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LIST OF DRUGS BANNED FOR MARKETING IN INDIA

The Government of India vide notifications published in the Gazette of India vide G.S.R. No. 578 (E) dated 23/07/1983 and subsequent amendments, made under Section 26 A of Drugs and Cosmetics Act, 1940 has prohibited the manufacture, sale and distribution of the following categories of fixed dose combinations which do not have any therapeutic justification or are likely to involve risk to human beings:

G.S.R. No. 578 (E) dt 23-07-1983

  • (1) Amidopyrine.
  • (2) Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers.
  • (3) Fixed dose combinations of Atropine and Analgesic and Antipyretics.
  • (4) Fixed dose combinations of Strychnine and Caffeine in tonics.
  • (5) Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.
  • (6) Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.
  • (7) Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs.
  • (8) Phenacetin.
  • (9) Fixed dose combinations of antihistaminic with anti-diarrhoeals.
  • (10) Fixed dose combinations of Penicillin with Sulphonamides.
  • (11) Fixed dose combinations of Vitamins with Analgesics.
  • (12) Fixed dose combinations of Tetracycline with Vitamin C.

G.S.R. No. 793 (E) dtd 13-12-1995

(13) Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use only.

[Substituted vide G.S.R. No. 255 (E) dtd 07-04-2021]

(14) Fixed Dose Combination of corticosteroid with any other drug [excluding Fixed Dose Combination of Tamsulosin HCI 0.4 mg (as film coated modified release tablet) + Deflazacort 30mg in hard gelatin capsule] for internal use except for preparations meant for meter dose inhalers and dry powder inhalers.

[Substituted vide GSR 738 (E) dtd 9.10.2009]

(15) Fixed dose combinations of Chloramphenicol with any other drug for internal use.

G.S.R. No. 304 (E) dtd 07-06-1991

(16) Fixed dose combinations of crude Ergot preparation except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headache.

G.S.R. No. 578 (E) dtd 23-07-1983

  • (17) Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).
  • (18) Penicillin skin/eye Ointment.
  • (19) Tetracycline Liquid Oral preparations.
  • (20) Nialamide.
  • (21) Practolol.
  • (22)  Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.

G.S.R. No. 49 (E) dtd 31-01-1984

(23) Methaqualone.

G.S.R. No. 322 (E) dtd 03-05-1984

  • (24) Oxytetracycline Liquid Oral preparations.
  • (25) Demeclocycline Liquid Oral preparations.

G.S.R. No. 863 (E) dtd 22-11-1985

(26) Methaqualone.

G.S.R. No. 743 (E) dtd 10-08-1989

(27) Fixed dose combination of Oestrogen and Progestin (other than oral contraceptives) containing per tablet Estrogen content of more than 50 mcg (equivalent to Ethinyl Estradiol) and Progestin content of more than 3 mg (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone. (Subs. By Noti. No. 743 (E) dt 10-08-1989)

G.S.R. No. 999 (E) dtd 26-12-1990

(28) Fixed dose combinations of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.

G.S.R 100 (E) dtd 11-02-2003 (with effect from 11-02-2003)

(29) Fixed dose combination of Rifampicin, Isoniazid and Pyrazinamide, except those which provide daily adult dose given below: -

DrugsMinimumMaximum
Rifampicin450 mg 600 mg
Isoniazid300 mg400 mg
Pyrazinamide1000 mg1500 mg

G.S.R. No. 999 (E) dtd 26-12-1990

  • (30) Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India.
  • (31) The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia.
  • (32) All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate.

G.S.R. No. 69 (E) dtd 11-02-1991

  • (33) Fixed dose combination of Ethambutol with INH other than the following: INH Ethambutol 200 mg. 600 mg. 300 mg. 800 mg
  • (34) Fixed dose combination containing more than one antihistamine.
  • (35) Fixed dose combination of anthelmintic with cathartic/purgative except for piperazine.

Substituted vide G.S.R 290 (E) dtd 16-04-2008

(36) Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine.

G.S.R. No. 69 (E) dtd 11-02-1991

(37) Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.

Substituted vide G.S.R 603 (E) dtd 24-08-2001 (with effect from 01-09-2002)

(38) Fixed dose combination of Metoclopramide with other drugs except combination of Metoclopramide with Aspirin/ Paracetamol with effect from 1st September, 2002.

G.S.R. No. 69 (E) dtd 11-02-1991

  • (39) Fixed dose combination of centrally acting, antitussive with antihistamine, having atropine like activity in expectorants.
  • (40) Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine.
  • (41) Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and / or central nervous system stimulant and such preparations containing alcohol more than 20% proof.
  • (42) Fixed dose combination containing Pectin and/or Kaolin with any drug which is systemically absorbed from GI tract except for combination of Pectin and/or Kaolin with drugs not systemically absorbed.

G.S.R. No. 304 (E) dtd 07-06-1991

(43) Chloral Hydrate as a drug.

G.S.R. No. 612 (E) dtd 09-08-1994

  • (44) Dovers Powder I.P.
  • (45) Dover's Powder Tablets I.P.

G.S.R. No. 731 (E) dtd30-09-1994

  • (46) Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.
  • (47) Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.
  • (48) Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.
  • (49) Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.
  • (50) Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.
  • (51) Fixed dose combination of antidiarrhoeals with electrolytes.

G.S.R. No. 57 (E) dtd 07-02-1995

(43) Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters:

(a)  Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:- Sodium - 50 to 90 millimoles. Total osmolarity - 240 - 290 milli osmoles. Dextrose : Sodium molar ratio - Not less than 1:1 and not more than 3:1 (b)  Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain :- Total osmolarity - Not more than 2900 milli osmoles. Precooked rice- Equivalent to not less than 50 gm and not more than 80 gm as total replacement of Dextrose. (c)  Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salt conforming to the parameters specified above and labeled with the indication for "Adult Choleratic Diarrhoea" only. (d)  Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharin sweetening agent.

G.S.R. No. 633 (E) dtd 30-09-1995, GSR No. 123 (E) dtd 11-03-1996 and GSR No. 230 (E) dtd 04-06-1996

  • (53) Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
  • (54) Fixed dose combination of Analgin with any other drug. [Words "other than antispasmodics"omitted vide G.S.R. No.405 (E) dtd 03-06-1996]
  • Clarification : Fixed dose combination of Analgin with any other drug other than antispasmodics were banned by the Government of India vide G.S.R. No. 633(E), dated 13.09.1995. However, the Drug Action Forum contended before the Supreme Court that the preparations of Analgin and antispasmodics should also be banned. Dr. J.S. Bajaj, being directed by the court, submitted his report supporting these contentions.
    On 17th Dec. 1996, a learned additional Solicitor submitted that the Central Government has decided that all State/U.T. Drug Licensing Authorities will be given directions by the Government under Section 33-P of the Drugs and Cosmetics Act, to suspend manufacturing licenses of all fixed dose formulations of Analgin including Analgin with Antispasmodics till further notice. Accordingly, the Government of India, under letter dated 17th Dec.1996, issued such directives. In view of the above directives, the manufacture, sale and distribution of fixed dose combinations of Analgin and antispasmodics is prohibited.

  • (55) Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS).
  • (56) Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug.

G.S.R. No. 93 (E) dtd 25-02-1997

(57)  Parenteral preparations containing fixed dose combination of streptomycin with penicillins with effect from 01-01-1998.

G.S.R. No. 499 (E) dtd 14-08-1998

  • (57) Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.
  • (58) Fenfluramine and Dexfenfluramine.
  • (59) Fixed dose combination of haemoglobin in any form (natural or synthetic).
  • (60) Fixed dose combination of Pancreatin and Pancrelipase containing amylase, protease, and lipase with any other enzyme.

Both 59 & 60 added by G.S.R. 590 (E) dtd 17-8-1999.

Sr. No. 59 & 60 omitted by G.S.R. 704(E) dtd 20-10-1999.)

G.S.R. No. 169 (E) dt 12-03-2001

(59)  Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.

G.S.R. No. 885 (E) dtd 11-12-2009 (with effect from 11-12-2009)

(60)  Rimonabant.

G.S.R. No. 702 (E) dtd 20-10-1999 (with effect from 1-1-2001)

(61)  Fixed dose combination of Vitamin B1, Vitamin B6 and Vitamin B12 for human use with effect from 01-01-2001

G.S.R. No. 814 (E) dtd 16-12-1999 (w.e.f. 01-09-2000)

  • (62) Fixed dose combination of haemoglobin in any form (natural or synthetic).
  • (63) Fixed dose combination of Pancreatin and Pancrelipase containing amylase, protease and lipase with any other enzyme.

G.S.R. No. 170 (E) dtd 12-03-2001 (with effect from 01-01-2002)

  • (64) Fixed dose combination of Nitrofurantoin and trimethoprim.
  • (65) Fixed dose combination of Phenobarbitone with any anti-asthmatic drug.
  • (66) Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine.
  • (67) Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona.
  • (68) Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propantheline Bromide.
  • (69) Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole.
  • (70) Fixed dose combination of Loperamide Hydrochloride with Furazolidone.
  • (71) Fixed dose combination of Cyproheptadine with Lysine or Peptone.

G.S.R 603 (E) dtd 13-08-2001 (with effect from 01-09-2002)

(72)  Fixed dose combination of Metoclopramide with other drugs except combination of Metoclopramide with Aspirin/ Paracetamol with effect from 1st September, 2002.

G.S.R 100 (E) dtd 11-02-2003 (with effect from 11-02-2003)

(75) Fixed dose combination of Rifampicin, Isoniazid and Pyrazinamide, except those which provide daily adult dose given below: -

DrugsMinimumMaximum
Rifampicin450 mg 600 mg
Isoniazid300 mg400 mg
Pyrazinamide1000 mg1500 mg

G.S.R. No. 780 (E) dtd 01-10-2003 (with effect from 01-10-2003)

(76)  Phenformin for human use.

G.S.R. No. 810 (E) dtd 13-12-2004 (with effect from 13-12-2004)

(77)  Rofecoxib and its formulations for human use.

G.S.R. No. 510 (E) dtd 25-7-2005 (with effect from 25-7-2005)

(78)  Valdecoxib and its formulations for human use.

G.S.R. No. 499 (E) dtd 4-7-2008 (with effect from 5-7-2008)

(79)  Diclofenac and its formulations for animal use.

G.S.R. No. 910 (E) dtd 12-11-2010 (with effect from 12-11-2010)

(80)  Rosiglitazone and its formulations for human use.

G.S.R. No. 82 (E) dtd 10-2-2011 (with effect from 10-2-2011)

  • (81) Nimesulide formulations for human use in children below 12 years of age.
  • (82) Cisapride and its formulations for human use.
  • (83) Phenylpropanolamine and its formulations for human use,*
  • (84) Human Placental Extract and its formulations for human use except its,
  • (i)  Topical application for wound healing, and (ii)  Injection for pelvic inflammatory disease
  • (Substituted videG.S.R. No. 418 (E) dtd 30-5-2011 (with effect from 30-5-2011)
  • (85) Sibutramine and its formulations for human use, and
  • (86) R-Sibutramine and its formulations for human use.

G.S.R. No. 218 (E) dtd 16-3-2011 (with effect from 16-3-2011)

  • (87) Gatifloxacin formulation for systemic use in human by any route including oral and injectable; and
  • (88) Tegaserod and its formulations for human use.

G.S.R. No. 752 (E) dtd 12-10-2011 (with effect from 12-10-2011)

(89)  Letrozole for induction of ovulation in anovulatory infertility.

G.S.R. No. 432 (E) dtd 7-6-2012 (with effect from 7-6-2012)

(90)  Serodiagnostic test kits for diagnosis of tuberculosis.

G.S.R. No. 332 (E) dtd 23-5-2013 (with effect from 23-5-2013) ƫ

(91)  [Dextropropoxyphene]¢ and formulations containing Dextropropoxyphene for human use.

G.S.R. No. 377 (E) dt 18-6-2013 (with effect from 18-6-2013)

(Quashed in WP Nos 28354/2013 c/w 32766-32768/2013 Lundbeck India Pvt Ltd v. UOI and others, High Court of Karnataka, D/d 14.8.2013)

(92)  Fixed dose combination of Flupenthixol+Melitracen for human use.

G.S.R. No. 498 (E) dtd 11-7-2014 (with effect from 11-7-2014)

Fixed dose combination of Flupenthixol and Melitracen for human use

G.S.R. No. 378 (E) dtd 18-6-2013

(revoked allowing the use of drug with condition “The drug is indicated for Severe pain or pain due to tumor and also for bringing down temperature in refractory cases when other antipyretics fail to do so.” vide G.S.R. No.86(E) dtd 13-02-2014)

(93)  Analgin and all formulations containing Analgin for human use.

G.S.R. No. 379 (E) dtd 18-6-2013 (with effect from 18-6-2013)

[G.S.R. No. 520 (E) dt 31-7-2013 revoked the notification with certain conditions]

(94)  Pioglitazone and all formulations containing Pioglitazone for human use.

G.S.R . 29 (E) dtd 17-01-2014 (Remained effective from 17-01-2014 to 30-06-2018)

(95)  The drug oxytocin shall be manufactured for sale or for distribution or sold in the manner specified below, in addition to the provisions contained in the Act and Rules made thereunder, namely:-

(i)  The manufacturers of bulk oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug. (ii)  The formulations meant for veterinary use shall be sold to the veterinary hospitals only.

S. O. 1352 (E) dtd 23-03-2018 (with effect from 23-03-2018)

(96)  Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria.

G.S.R. 411 (E) dtd 27-04-2018 (with effect from 01-09-2018)Extended vide G. S. R. 602 (E) dtd 29-06-2018

(97)  The Oxytocin in any form or name shall not be allowed to be sold through retail Chemist.

S. O. 4379 (E) dtd 07-09-2018 (with effect from 08-09-2018)(Delhi High Court set asided in Wockhardt Limited And Anr vs Union Of India And Anr., W.P.(C) 9739/2018, D/j 7.1.2019, 2019:DHC:3)

(98)  Fixed dose combination of Aceclofenac + Paracetamol + Rabeprazole.

S. O. 4380 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(99)  Fixed dose combination of Nimesulide + Diclofenac.

S. O. 4381 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(100)  Fixed dose combination of Nimesulide + Cetirizine + Caffeine.

S. O. 4382 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(101)  Fixed dose combination of Nimesulide + Tizanidine.

S. O. 4383 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(102)  Fixed dose combination of Paracetamol + Cetirizine + Caffeine.

S. O. 4384 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(103)  Fixed dose combination of Diclofenac + Tramadol + Chlorzoxazone.

S. O. 4385 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(104)  Fixed dose combination of Dicyclomine + Paracetamol + Domperidone.

S. O. 4386 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(105)  Fixed dose combination of Diclofenac + Tramadol + Paracetamol.

S. O. 4387 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(106)  Fixed dose combination of Diclofenac + Paracetamol + Chlorzoxazone + Famotidine.

S. O. 4388 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(107)  Fixed dose combination of Naproxen + Paracetamol.

S. O. 4389 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(108)  Fixed dose combination of Nimesulide + Serratiopeptidase.

S. O. 4390 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(109)  Fixed dose combination of Paracetamol + Diclofenac + Famotidine.

S. O. 4391 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(110)  Fixed dose combination of Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol.

S. O. 4392 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(111)  Fixed dose combination of Omeprazole + Paracetamol + Diclofenac.

S. O. 4393 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(112)  Fixed dose combination of Nimesulide + Paracetamol Injection.

S. O. 4394 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(113)  Fixed dose combination of Tamsulosin + Diclofenac.

S. O. 4395 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(114)  Fixed dose combination of Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + Caffeine.

S. O. 4396 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(115)  Fixed dose combination of Diclofenac + Zinc Carnosine.

S. O. 4397 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(116)  Fixed dose combination of Diclofenac + Paracetamol + Chlorpheniramine Maleate + Magnesium Trisillicate.

S. O. 4398 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(117)  Fixed dose combination of Paracetamol + Pseudoephedrine + Cetirizine.

S. O. 4399 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(118)  Fixed dose combination of Phenylbutazone + Sodium Salicylate.

S. O. 4400 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(119)  Fixed dose combination of Lornoxicam + Paracetamol + Trypsin.

S. O. 4401 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(120)  Fixed dose combination of Paracetamol + Mefenamic Acid + Ranitidine + Dicyclomine.

S. O. 4402 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(121)  Fixed dose combination of Nimesulide + Dicyclomine.

S. O. 4403 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(122)  Fixed dose combination of Heparin + Diclofenac.

S. O. 4404 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(123)  Fixed dose combination of Glucosamine + Methyl Sulfonyl Methane + Vitamin D3 + Manganese + Boron + Copper + Zinc.

S. O. 4405 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(124)  Fixed dose combination of Paracetamol + Tapentadol.

S. O. 4406 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(125)  Fixed dose combination of Tranexamic Acid + Proanthocyanidin.

S. O. 4407 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(126)  Fixed dose combination of Lornoxicam + Paracetamol + Tramadol.

S. O. 4408 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(127)  Fixed dose combination of Lornoxicam + Paracetamol + Serratiopeptidase.

S. O. 4409 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(128)  Fixed dose combination of Diclofenac + Paracetamol + Magnesium Trisilicate.

S. O. 4410 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(129)  Fixed dose combination of Paracetamol + Domperidone + Caffeine.

S. O. 4411 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(130)  Fixed dose combination of Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol.

S. O. 4412 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(131)  4412. Combikit of 3 tablets of Serratiopeptidase (enteric coated 20000 units) + Diclofenac Potassium & 2 tablets of Doxycycline.

S. O. 4413 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(132)  Fixed dose combination of Nimesulide + Paracetamol Suspension.

S. O. 4414 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(133)  Fixed dose combination of Aceclofenac + Paracetamol + Famotidine.

S. O. 4415 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(134)  Fixed dose combination of Aceclofenac + Zinc Carnosine.

S. O. 4416 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(135)  Fixed dose combination of Paracetamol + Disodium Hydrogen Citrate + Caffeine.

S. O. 4417 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(136)  Fixed dose combination of Paracetamol + DL Methionine.

S. O. 4418 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(137)  Fixed dose combination of Disodium Hydrogen Citrate + Paracetamol.

S. O. 4419 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(138)  Fixed dose combination of Paracetamol + Caffeine + Codeine Phosphate.

S. O. 4420 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(139)  Fixed dose combination of Aceclofenac (SR) + Paracetamol.

S. O. 4421 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(140)  Fixed dose combination of Diclofenac + Paracetamol Injection.

S. O. 4422 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(141)  Fixed dose combination of Azithromycin + Cefixime.

S. O. 4423 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(142)  Fixed dose combination of Amoxicillin + Dicloxacillin.

S. O. 4424 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(143)  Fixed dose combination of Azithromycin + Levofloxacin.

S. O. 4425 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(144)  Fixed dose combination of Cefixime + Linezolid.

S. O. 4426 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(145)  Fixed dose combination of Amoxicillin + Cefixime + Potassium Clavulanic Acid.

S. O. 4427 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(146)  Fixed dose combination of Ofloxacin + Nitazoxanide.

S. O. 4428 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(147)  Fixed dose combination of Cefpodoxime Proxetil + Levofloxacin.

S. O. 4429 (E) dtd 07-09-2018 (with effect from 08-09-2018)(Delhi High Court set asided in Hetero Healthcare Ltd. vs Union Of India And Anr., W.P.(C) 10220/2018 & CM Appln. No.39861/2018, D/j 18.02.2019, 2019:DHC:1101)

(148)  4429. Combikit of Azithromycin dihydrare, Secnidazole and Fluconazole.

S. O. 4430 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(149)  Fixed dose combination of Levofloxacin + Ornidazole + Alpha Tocopherol Acetate.

S. O. 4431 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(150)  Fixed dose combination of Nimorazole + Ofloxacin.

S. O. 4432 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(151)  Fixed dose combination of Azithromycin + Ofloxacin.

S. O. 4433 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(152)  Fixed dose combination of Amoxycillin + Tinidazole.

S. O. 4434 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(153)  Fixed dose combination of Doxycyclin + Serratiopeptidase.

S. O. 4435 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(154)  Fixed dose combination of Cefixime + Levofloxacin.

S. O. 4436 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(155)  Fixed dose combination of Ofloxacin + Metronidazole + Zinc Acetate.

S. O. 4437 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(156)  Fixed dose combination of Diphenoxylate + Atropine + Furazolidone.

S. O. 4438 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(157)  4438. Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole Tablets.

S. O. 4439 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(158)  Fixed dose combination of Ciprofloxacin + Phenazopyridine.

S. O. 4440 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(159)  Fixed dose combination of Amoxycillin + Dicloxacillin + Serratiopeptidase.

S. O. 4441 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(160)  Fixed dose combination of Azithromycin + Cefpodoxime.

S. O. 4442 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(161)  Fixed dose combination of Lignocaine + Clotrimazole + Ofloxacin + Beclomethasone.

S. O. 4443 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(162)  Fixed dose combination of Cefuroxime + Linezolid.

S. O. 4444 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(163)  Fixed dose combination of Ofloxacin + Ornidazole + Zinc Bisglycinate.

S. O. 4445 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(164)  Fixed dose combination of Metronidazole + Norfloxacin.

S. O. 4446 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(165)  Fixed dose combination of Ciprofloxacin + Fluticasone + Clotrimazole + Neomycin.

S. O. 4447 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(166)  Fixed dose combination of Metronidazole + Tetracycline.

S. O. 4448 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(167)  Fixed dose combination of Cephalexin + Neomycin + Prednisolone.

S. O. 4449 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(168)  Fixed dose combination of Azithromycin + Ambroxol.

S. O. 4450 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(169)  Fixed dose combination of Cilnidipine + Metoprolol Succinate + Metoprolol Tartrate.

S. O. 4451(E) dtd 07-09-2018 (with effect from 08-09-2018)

(170)  Fixed dose combination of L-Arginine + Sildenafil.

S. O. 4452 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(171)  Fixed dose combination of Atorvastatin + Vitamin D3 + Folic Acid + Vitamin B12 + Pyridoxine.

S. O. 4453 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(172)  Fixed dose combination of Metformin + Atorvastatin.

S. O. 4454 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(173)  Fixed dose combination of Clindamycin + Telmisartan.

S. O. 4455 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(174)  Fixed dose combination of Olmesartan + Hydrochlorothiazide + Chlorthalidone.

S. O. 4456 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(175)  Fixed dose combination of L-5-Methyltetrahydrofolate Calcium + Escitalopram.

S. O. 4457(E) dtd 07-09-2018 (with effect from 08-09-2018)

(176)  Fixed dose combination of Paracetamol + Promethazine.

S. O. 4458(E) dtd 07-09-2018 (with effect from 08-09-2018)

(177)  Fixed dose combination of Betahistine + Ginkgo Biloba Extract + Vinpocetine + Piracetam.

S. O. 4459 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(178)  Fixed dose combination of Cetirizine + Diethyl Carbamazine.

S. O. 4460 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(179)  Fixed dose combination of Doxylamine + Pyridoxine + Mefenamic Acid + Paracetamol.

S. O. 4461 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(180)  Fixed dose combination of Drotaverine + Clidinium + Chlordiazepoxide.

S. O. 4462 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(181)  Fixed dose combination of Flupentixol + Escitalopram.

S. O. 4463 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(182)  Fixed dose combination of Gabapentin + Mecobalamin + Pyridoxine + Thiamine.

S. O. 4464 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(183)  Fixed dose combination of Imipramine + Chlordiazepoxide + Trifluoperazine + Trihexyphenidyl.

S. O. 4465 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(184)  Fixed dose combination of Chlorpromazine + Trihexyphenidyl.

S. O. 4466 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(185)  Fixed dose combination of Ursodeoxycholic Acid + Silymarin.

S. O. 4467 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(186)  Fixed dose combination of Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride1/2/1/2mg.

S. O. 4468 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(187)  Fixed dose combination of Gliclazide 80 mg + Metformin 325 mg.

S. O. 4469 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(188)  Fixed dose combination of Voglibose + Metformin + Chromium Picolinate.

S. O. 4470 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(189)  Fixed dose combination of Pioglitazone 7.5/7.5mg + Metformin 500/1000mg.

S. O. 4471 (E) dtd 07-09-2018 (with effect from 08-09-2018)(Delhi High Court set asided in M/S Micro Labs Limited vs Drugs Controller General Of India, W.P.(C) 9978/2018 and CM APPL.38873/2018 & 38874/2018, D/j 13.02.2019, 2019:DHC:944)

(190)  Fixed dose combination of Glimepiride 1mg/2mg/3mg + Pioglitazone 15mg/15mg/15mg + Metformin 1000mg/1000mg/1000mg.

S. O. 4472 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(191)  Fixed dose combination of Glimepiride 1mg/2mg+ Pioglitazone 15mg/15mg + Metformin 850mg/850mg.

S. O. 4473 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(192)  Fixed dose combination of Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 2mg.

S. O. 4474 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(193)  Fixed dose combination of Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 1mg.

S. O. 4475 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(194)  Fixed dose combination of Metformin 500mg/500mg+Gliclazide SR 30mg/60mg + Pioglitazone 7.5mg/7.5mg.

S. O. 4476 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(195)  Fixed dose combination of Voglibose + Pioglitazone + Metformin.

S. O. 4477 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(196)  Fixed dose combination of Metformin + Bromocriptine.

S. O. 4478 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(197)  Fixed dose combination of Metformin + Glimepiride + Methylcobalamin.

S. O. 4479 (E) dtd 07-09-2018 (with effect from 08-09-2018)(Delhi High Court set asided in Lupin Limited and Anr vs UoI & Anr, WP(C) 10917/2018 & CM Appl No. 45389/2018, D/j 22.2.2019, 2019:DHC:1236)

(198)  Fixed dose combination of Pioglitazone 30 mg + Metformin 500 mg.

S. O. 4480 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(199)  Fixed dose combination of Glipizide 2.5mg + Metformin 400 mg.

S. O. 4481 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(200)  Fixed dose combination of Pioglitazone 15mg + Metformin 850 mg.

S. O. 4482 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(201)  Fixed dose combination of Metformin ER + Gliclazide MR + Voglibose.

S. O. 4483 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(202)  Fixed dose combination of Chromium Polynicotinate + Metformin.

S. O. 4484 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(203)  Fixed dose combination of Metformin + Gliclazide + Piogllitazone + Chromium Polynicotinate.

S. O. 4485 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(204)  Fixed dose combination of Metformin + Gliclazide + Chromium Polynicotinate.

S. O. 4486 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(205)  Fixed dose combination of Metformin (Sustainded Release) 500mg + Pioglitazone 15 mg + Glimepiride 3mg.

S. O. 4487 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(206)  Fixed dose combination of Metformin (SR) 500mg + Pioglitazone 5mg.

S. O. 4488 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(207)  Fixed dose combination of Chloramphenicol + Beclomethasone + Clotrimazole + Lignocaine.

S. O. 4489 (E) dtd 07-09-2018 (with effect from 08-09-2018)(Amended vide S. O. 4973(E) dtd 25-09-2018)

(208)  Fixed dose combination of Clotrimazole + Ofloxaxin + Lignocaine + Glycerine and Propylene Glycol.

S. O. 4490 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(209)  Fixed dose combination of Chloramphennicol + Lignocaine + Betamethasone + Clotrimazole + Ofloxacin + Antipyrine.

S. O. 4491 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(210)  Fixed dose combination of Ofloxacin + Clotrimazole + Betamethasone + Lignocaine.

S. O. 4492 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(211)  Fixed dose combination of Gentamicin Sulphate + Clotrimazole + Betamethasone + Lignocaine.

S. O. 4493 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(212)  Fixed dose combination of Ofloxacin +Clotrimazole + Beclomethasone + Lignocaine.

S. O. 4494 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(213)  Fixed dose combination of Becloemthasone + Clotrimazole + Chloramphenicol + Gentamycin + Lignocaine Ear drop.

S. O. 4495 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(214)  Fixed dose combination of Flunarizine + Paracetamol + Domperidone.

S. O. 4496 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(215)  Fixed dose combination of Rabeprazole + Zinc Carnosine.

S. O. 4497 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(216)  Fixed dose combination of Magaldrate + Famotidine + Simethicone.

S. O. 4498 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(217)  Fixed dose combination of Cyproheptadine + Thiamine.

S. O. 4499 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(218)  Fixed dose combination of Magaldrate + Ranitidine + Pancreatin + Domperidone.

S. O. 4500 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(219)  Fixed dose combination of Ranitidine + Magaldrate + Simethicone.

S. O. 4501 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(220)  Fixed dose combination of Magaldrate + Papain + Fungul Diastase + Simethicone.

S. O. 4502 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(221)  Fixed dose combination of Rabeprazole + Zinc + Domperidone.

S. O. 4503 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(222)  Fixed dose combination of Famotidine + Oxytacaine + Magaldrate.

S. O. 4504 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(223)  Fixed dose combination of Ranitidine + Domperidone + Simethicone.

S. O. 4505 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(224)  Fixed dose combination of Alginic Acid + Sodium Bicarbonate + Dried Aluminium Hydroxide + Magnesium Hydroxide.

S. O. 4506 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(225)  Fixed dose combination of Clidinium + Paracetamol + Dicyclomine + Activated Dimethicone.

S. O. 4507 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(226)  Fixed dose combination of Furazolidone + Metronidazole + Loperamide.

S. O. 4508 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(227)  Fixed dose combination of Rabeprazole + Diclofenac + Paracetamol.

S. O. 4509 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(228)  Fixed dose combination of Ranitidine + Magaldrate.

S. O. 4510 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(229)  Fixed dose combination of Norfloxacin + Metronidazole + Zinc Acetate.

S. O. 4511 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(230)  Fixed dose combination of Zinc Carnosine + Oxetacaine.

S. O. 4512 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(231)  Fixed dose combination of Oxetacaine + Magaldrate + Famotidine.

S. O. 4513 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(232)  Fixed dose combination of Pantoprazole (as Enteric Coated Tablet) + Zinc Carnosine (as Film Coated Tablets).

S. O. 4514 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(233)  Fixed dose combination of Zinc Carnosine + Magnesium Hydroxide + Dried Aluminium Hydroxide + Simethicone.

S. O. 4515 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(234)  Fixed dose combination of Zinc Carnosine + Sucralfate.

S. O. 4516 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(235)  Fixed dose combination of Mebeverine & Inner HPMC capsule (Streptococcus Faecalis + Clostridium butyricum + Bacillus mesentricus + Lactic Acid Bacillus).

S. O. 4517 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(236)  Fixed dose combination of Clindamycin + Clotrimazole + Lactic Acid Bacillus.

S. O. 4518 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(237)  Fixed dose combination of Sildenafil + Estradiol Valerate.

S. O. 4519 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(238)  Fixed dose combination of Clomifene Citrate + Ubidecarenone + Zinc + Folic Acid + Methylcobalamin + Pyridoxine + Lycopene + Selenium + Levocarnitine Tartrate + L-Arginine.

S. O. 4520 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(239)  Fixed dose combination of Thyroxine + Pyridoxine + Folic Acid.

S. O. 4521 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(240)  Fixed dose combination of Gentamycin + Dexamethasone + Chloramphenicol + Tobramycin + Ofloxacin.

S. O. 4522 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(241)  Fixed dose combination of Dextromethorphan + Levocetirizine + Phenylephrine + Zinc.

S. O. 4523 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(242)  Fixed dose combination of Nimesulide + Loratadine + Phenylephrine + Ambroxol.

S. O. 4524 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(243)  Fixed dose combination of Bromhexine + Phenylephrine + Chlorepheniramine Maleate.

S. O. 4525 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(244)  Fixed dose combination of Dextromethorphan + Bromhexine + Guaiphenesin.

S. O. 4526 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(245)  Fixed dose combination of Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + Caffeine.

S. O. 4527 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(246)  Fixed dose combination of Nimesulide + Phenylephrine + Caffeine + Levocetirizine.

S. O. 4528 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(247)  Fixed dose combination of Azithromycin + Acebrophylline.

S. O. 4529 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(248)  Fixed dose combination of Diphenhydramine + Terpine + Ammonium Chloride + Sodium Chloride + Menthol.

S. O. 4530 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(249)  Fixed dose combination of Nimesulide + Paracetamol + Cetirizine + Phenylephrine.

S. O. 4531 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(250)  Fixed dose combination of Paracetamol + Loratadine + Dextromethophan + Pseudoepheridine + Caffeine.

S. O. 4532 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(251)  Fixed dose combination of Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate.

S. O. 4533 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(252)  Fixed dose combination of Cetirizine + Phenylephrine + Paracetamol + Zinc Gluconate.

S. O. 4534 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(253)  Fixed dose combination of Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + Menthol.

S. O. 4535 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(254)  Fixed dose combination of Dextromethorphen + Bromhexine + Chlorpheniramine Maleate + Guaiphenesin.

S. O. 4536 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(255)  Fixed dose combination of Levocetirizine + Ambroxol + Phenylephrine + Guaiphenesin.

S. O. 4537 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(256)  Fixed dose combination of Dextromethorphan + Chlorpheniramine + Chlorpheniramine Maleate.

S. O. 4538 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(257)  Fixed dose combination of Cetirizine + Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine + Menthol.

S. O. 4539 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(258)  Fixed dose combination of Chlorpheniramine + Phenylephrine + Caffeine.

S. O. 4540 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(259)  Fixed dose combination of Dextromethorphan + Triprolidine + Phenylephrine.

S. O. 4541 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(260)  Fixed dose combination of Terpin hydrate + Dextromethorphan + Menthol.

S. O. 4542 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(261)  Fixed dose combination of Dextromethorphan + Phenylephrine + Zinc Gluconate + Menthol.

S. O. 4543 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(262)  Fixed dose combination of Dextromethorphan + Phenylephrine + Zinc Gluconate + Menthol Syrup.

S. O. 4544 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(263)  Fixed dose combination of Enrofloxacin + Bromhexin.

S. O. 4545 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(264)  Fixed dose combination of Bromhexine + Dextromethorphan + Phenylephrine + Menthol.

S. O. 4546 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(265)  Fixed dose combination of Levofloxacin + Bromhexine.

S. O. 4547 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(266)  Fixed dose combination of Levocetirizine + Ranitidine.

S. O. 4548 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(267)  Fixed dose combination of Levocetirizine + Phenylephrine + Ambroxol + Guaiphenesin + Paracetamol.

S. O. 4549 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(268)  Fixed dose combination of Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol + Menthol.

S. O. 4550 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(269)  Fixed dose combination of Paracetamol + Pseudoephedrine + Dextromethorphan + Cetirizine.

S. O. 4551 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(270)  Fixed dose combination of Diphenhydramine + Guaiphenesin + Ammonium Chloride + Bromhexine.

S. O. 4552 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(271)  Fixed dose combination of Chlorpheniramine + Dextromethorphan + Phenylephrine + Paracetamol.

S. O. 4553 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(272)  Fixed dose combination of Dextromethorphen + Promethazine.

S. O. 4554 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(273)  Fixed dose combination of Diethylcabamazine Citrate + Cetirizine + Guaiphenesin.

S. O. 4555 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(274)  Fixed dose combination of Pseudoephedrine + Dextromethorphan + Cetirizine.

S. O. 4556 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(275)  Fixed dose combination of Chlorpheniramine + Phenylephrine + Dextromethophan + Menthol.

S. O. 4557 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(276)  Fixed dose combination of Ambroxol + Terbutaline + Dextromethorphan.

S. O. 4558 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(277)  Fixed dose combination of Dextromethorphan + Chlorpheniramine + Guaiphenesin.

S. O. 4559 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(278)  Fixed dose combination of Terbutaline + Bromhexine + Guaiphenesin + Dextromethorphan.

S. O. 4560 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(279)  Fixed dose combination of Dextromethorphan + Tripolidine + Phenylephirine.

S. O. 4561 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(280)  Fixed dose combination of Paracetamol + Dextromethorphan + Chlorpheniramine.

S. O. 4562 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(281)  Fixed dose combination of Pholcodine + Phenylephrine + Promethazine.

S. O. 4563 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(282)  Fixed dose combination of Codeine + Levocetirizine + Menthol.

S. O. 4564 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(283)  Fixed dose combination of Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine.

S. O. 4565 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(284)  Fixed dose combination of Cetirizine + Phenylephrine + Dextromethorphan + Menthol.

S. O. 4566 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(285)  Fixed dose combination of Roxithromycin + Serratiopeptidase.

S. O. 4567 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(286)  Fixed dose combination of Paracetamol + Phenylephrine + Triprolidine.

S. O. 4568 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(287)  Fixed dose combination of Acetaminophen + Loratadine + Ambroxol + Phenylephrine.

S. O. 4569 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(288)  Fixed dose combination of Cetirizine + Acetaminophen + Dextromethorphan + Phenyephrine + Zinc Gluconate.

S. O. 4570 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(289)  Fixed dose combination of Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + Menthol.

S. O. 4571 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(290)  Fixed dose combination of Cetirizine + Dextromethorphan + Zinc Gluconate + Menthol.

S. O. 4572 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(291)  Fixed dose combination of Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + Ambroxol.

S. O. 4573 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(292)  Fixed dose combination of Levocetirizine + Montelukast + Acebrophylline.

S. O. 4574 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(293)  Fixed dose combination of Dextromethorphan + Phenylephrine + Ammonium Chloride + Menthol.

S. O. 4575 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(294)  Fixed dose combination of Dextromethorphan + Bromhexine + Guaiphenesin + Menthol.

S. O. 4576 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(295)  Fixed dose combination of Acrivastine + Paracetamol + Caffeine + Phenylephrine.

S. O. 4577 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(296)  Fixed dose combination of Naphazoline + Carboxy Methyl Cellulose + Menthol + Camphor + Phenylephrine.

S. O. 4578 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(297)  Fixed dose combination of Dextromethorphan + Cetirizine.

S. O. 4579 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(298)  Fixed dose combination of Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine.

S. O. 4580 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(299)  Fixed dose combination of Terbutaline + Ambroxol + Guaiphenesin + Zinc + Menthol.

S. O. 4581 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(300)  Fixed dose combination of Codeine + Chlorpheniramine + Alcohol Syrup.

S. O. 4582 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(301)  Fixed dose combination of Dextromethorphan + Phenylephrine + Guaifenesin + Triprolidine.

S. O. 4583 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(302)  Fixed dose combination of Diethylcarbamazine + Cetirizine + Ambroxol.

S. O. 4584 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(303)  Fixed dose combination of Ethylmorphine + Noscapine + Chlorpheniramine.

S. O. 4585 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(304)  Fixed dose combination of Cetirizine + Dextromethorphan + Ambroxol.

S. O. 4586 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(305)  Fixed dose combination of Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine.

S. O. 4587 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(306)  Fixed dose combination of Paracetamol + Phenylephrine + Chlorpheniramine + Zinc Gluconate.

S. O. 4588 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(307)  Fixed dose combination of Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + Caffeine.

S. O. 4589 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(308)  Fixed dose combination of Levocetirizine + Dextromethorphan + Zinc.

S. O. 4590 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(309)  Fixed dose combination of Paracetamol + Phenylephrine + Levocetirizine + Caffeine.

S. O. 4591 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(310)  Fixed dose combination of Chlorphaniramine + Ammonium Chloride + Sodium Chloride.

S. O. 4592 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(311)  Fixed dose combination of Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine + Diphenhydramine.

S. O. 4593 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(312)  Fixed dose combination of Salbutamol + Bromhexine + Guaiphenesin + Menthol.

S. O. 4594 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(313)  Fixed dose combination of Chlorpheniramine + Ammonium Chloride + Noscapine + Sodium Citrate.

S. O. 4595 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(314)  Fixed dose combination of Cetirizine + Dextromethorphan + Bromhexine + Guaifenesin.

S. O. 4596 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(315)  Fixed dose combination of Diethyl Carbamazine + Chlorpheniramine + Guaifenesin.

S. O. 4597 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(316)  Fixed dose combination of Ketotifen + Cetirizine.

S. O. 4598 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(317)  Fixed dose combination of Terbutaline + Bromhexine + Etofylline.

S. O. 4599 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(318)  Fixed dose combination of Ketotifen + Theophylline.

S. O. 4600 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(319)  Fixed dose combination of Ambroxol + Salbutamol + Theophylline.

S. O. 4601 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(320)  Fixed dose combination of Cetririzine + Nimesulide + Phenylephrine.

S. O. 4602 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(321)  Fixed dose combination of Chlorpheniramine + Phenylephrine + Paracetamol + Zinc Gluconate.

S. O. 4603 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(322)  Fixed dose combination of Acetaminophen + Guaifenesin + Dextromethorphan + Chlorpheniramine.

S. O. 4604 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(323)  Fixed dose combination of Cetirizine + Dextromethorphan + Phenylephrine + Tulsi.

S. O. 4605 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(324)  Fixed dose combination of Cetirizine + Phenylephrine + Paracetamol + Ambroxol + Caffeine.

S. O. 4606 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(325)  Fixed dose combination of Guaifenesin + Dextromethorphan.

S. O. 4607 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(326)  Fixed dose combination of Levocetirizine + Paracetamol + Phenylephirine + Caffeine.

S. O. 4608 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(327)  Fixed dose combination of Ketotifen + Levocetrizine.

S. O. 4609 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(328)  Fixed dose combination of Paracetamol + Levocetirizine + Phenylephirine + Zinc Gluconate.

S. O. 4610 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(329)  Fixed dose combination of Paracetamol + Phenylephrine + Triprolidine + Caffeine.

S. O. 4611 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(330)  Fixed dose combination of Caffeine + Paracetamol + Phenylephrine + Cetirizine.

S. O. 4612 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(331)  Fixed dose combination of Dextromethorphan + Phenylephrine + Guaifenesin.

S. O. 4613 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(332)  Fixed dose combination of Ambroxol + Levocetirizine + Phenylephrine + Guaiphenesin + Menthol.

S. O. 4614 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(333)  Fixed dose combination of Pseudoephedrine + Cetirizine.

S. O. 4615 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(334)  Fixed dose combination of Dextromethorphan + Chlorpheniramine + Ammonium Chloride + Menthol.

S. O. 4616 (E) dtd 07-09-2018 (with effect from 08-09-2018)(Rescinded vide S. O. 697 (E) dtd 05-02-2019)

(335)  Fixed dose combination of Paracetamol + Caffeine + Phenylephrine + Chlorpheniramine.

S. O. 4617 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(336)  Fixed dose combination of Salbutamol + Aminophylline + Guaifenesin.

S. O. 4618 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(337)  Fixed dose combination of Salbutamol + Theophylline + Bromhexine.

S. O. 4619 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(338)  Fixed dose combination of Chlorpheniramine + Dextromethorphan + Guaifenesin + Phenylephrine.

S. O. 4620 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(339)  Fixed dose combination of Caffeine + Paracetamol + Chlorpheniramine.

S. O. 4621 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(340)  Fixed dose combination of Ammonium Chloride + Dextromethorphan + Cetirizine + Menthol.

S. O. 4622 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(341)  Fixed dose combination of Dextromethorphan + Paracetamol + Cetirizine + Phenylephrine.

S. O. 4623 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(342)  Fixed dose combination of Chlorpheniramine + Terpin + Antimony Potassium Tartrate + Ammonium Chloride + Sodium Citrate + Menthol.

S. O. 4624 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(343)  Fixed dose combination of Terbutaline Sulphate + Etofylline + Ambroxol.

S. O. 4625 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(344)  Fixed dose combination of Paracetamol + Codeine + Chlorpheniramine.

S. O. 4626 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(345)  Fixed dose combination of Paracetamol + Pseudoephedrine + Cetirizine + Caffeine.

S. O. 4627 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(346)  Fixed dose combination of Chlorpheniramine + Ammonium Chloride + Menthol.

S. O. 4628 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(347)  Fixed dose combination of N-Acetyl Cysteine + Ambroxol + Phenylephrine + Levocertirizine.

S. O. 4629 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(348)  Fixed dose combination of Dextromethorphan + Phenylephrine + Tripolidine + Menthol.

S. O. 4630 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(349)  Fixed dose combination of Salbutamol + Certirizine + Ambroxol.

S. O. 4631 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(350)  Fixed dose combination of Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin + Chlorpheniramine.

S. O. 4632 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(351)  Fixed dose combination of Nimesulide + Certirizine + Phenylephrine.

S. O. 4633 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(352)  Fixed dose combination of Naphazoline + Chlorpheniramine + Zinc Sulphate + Boric Acid + Sodium Chloride + Chlorobutol.

S. O. 4634 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(353)  Fixed dose combination of Dextromethorphan + Phenylephrine + Guaifenesin + Certirizine + Acetaminophen.

S. O. 4635 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(354)  Fixed dose combination of Guaifenesin + Bromhexine + Chlorpheniramine + Paracetamol.

S. O. 4636 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(355)  Fixed dose combination of Chlorpheniramine + Ammonium Chloride + Chloroform + Menthol.

S. O. 4637 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(356)  Fixed dose combination of Salbutamol + Choline Theophyllinate + Ambroxol.

S. O. 4638 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(357)  Fixed dose combination of Pseudoephedrine + Bromhexine.

S. O. 4639 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(358)  Fixed dose combination of Cetirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide.

S. O. 4640 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(359)  Fixed dose combination of Dextromethorphan + Cetirizine + Guaifenesin + Ammonium Chloride.

S. O. 4641 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(360)  Fixed dose combination of Ambroxol + Salbutamol + Choline Theophyllinate + Menthol.

S. O. 4642 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(361)  Fixed dose combination of Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + Phenylephrine

S. O. 4643 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(362)  Fixed dose combination of Chlorpheniramine + Vasaka + Tolubalsm + Ammonium Chloride + Sodium Citrate + Menthol.

S. O. 4644 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(363)  Fixed dose combination of Bromhexine + Cetirizine + Phenylephrine + Guaifenesin + Menthol.

S. O. 4645 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(364)  Fixed dose combination of Dextromethorphan + Ambroxol + Ammonium Chloride + Chlorpheniramine + Menthol.

S. O. 4646 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(365)  Fixed dose combination of Dextromethorphan + Phenylephrine + Cetirizine + Zinc + Menthol.

S. O. 4647 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(366)  Fixed dose combination of Terbutaline + N-Acetyl L-Cysteine + Guaifenesin.

S. O. 4648 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(367)  Fixed dose combination of Calcium Gluconate + Levocetirizine.

S. O. 4649 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(368)  Fixed dose combination of Paracetamol + Levocetirizine + Pseudoephedrine.

S. O. 4650 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(369)  Fixed dose combination of Salbutamol + Choline Theophyllinate + Carbocisteine.

S. O. 4651 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(370)  Fixed dose combination of Chlorpheniramine + Vitamin C.

S. O. 4652 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(371)  Fixed dose combination of Calcium Gluconate + Chlorpheniramine + Vitamin C.

S. O. 4653 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(372)  Fixed dose combination of Chlorpheniramine + Paracetamol + Pseudoephedrine + Caffeine.

S. O. 4654 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(373)  Fixed dose combination of Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase (as enteric coated granules) 10000 SP Units.

S. O. 4655 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(374)  Fixed dose combination of Paracetamol + Pheniramine.

S. O. 4656 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(375)  Fixed dose combination of Betamethasone + Fusidic Acid + Gentamycin + Tolnaftate + lodochlorhydroxyquinoline(ICHQ).

S. O. 4657 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(376)  Fixed dose combination of Clobetasol + Ofloxacin + Miconazole + Zinc Sulphate.

S. O. 4658 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(377)  Fixed dose combination of Clobetasole + Gentamicin + Miconazole + Zinc Sulphate.

S. O. 4659 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(378)  Fixed dose combination of Levocetirizine + Ambroxol + Phenylephrine + Paracetamol.

S. O. 4660 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(379)  Fixed dose combination of Permethrin + Cetrimide + Menthol.

S. O. 4661 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(380)  Fixed dose combination of Beclomethasone + Clotrimazole + Neomycin + Iodochlorohydroxyquinone.

S. O. 4662 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(381)  Fixed dose combination of Neomycin + Doxycycline.

S. O. 4663 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(382)  Fixed dose combination of Ciprofloxacin + Fluocinolone + Clotrimazole + Neomycin.

S. O. 4664 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(383)  Fixed dose combination of Clobetasol + Ofloxacin + Ketoconazole + Zinc Sulphate.

S. O. 4665 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(384)  Fixed dose combination of Betamethasone + Gentamicin + Tolnaftate + lodochlorhydroxyquinoline.

S. O. 4666 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(385)  Fixed dose combination of Clobetasol + Gentamicin + Tolnaftate + lodochlorhydroxyquinone + Ketoconazole.

S. O. 4667 (E) dtd 07-09-2018 (with effect from 08-09-2018)(Amended vide S. O. 4974(E) dtd 25-09-2018)

(386)  Fixed dose combination of Allantoin + Dimethicone + Urea + Propylene + Glycerin + Liquid Paraffin.

S. O. 4668 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(387)  Fixed dose combination of Acriflavine + Thymol + Cetrimide.

S. O. 4669 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(388)  Fixed dose combination of Betamethasone + Neomycin + Tolnaftate + lodo chloro hydroxyl quinoline + Cholorocresol.

S. O. 4670 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(389)  Fixed dose combination of Clobetasol + Neomycin + Miconazole + Clotrimazole.

S. O. 4671 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(390)  Fixed dose combination of Ketoconazole + Tea Tree oil + Allantion + Zinc Oxide + Aloe Vera + Jojoba oil + Lavander oil + Soap noodels.

S. O. 4672 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(391)  Fixed dose combination of Clobetasol + Ofloxacin + Ornidazole + Terbinafine.

S. O. 4673 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(392)  Fixed dose combination of Clobetasol + Neomycin + Miconazole + Zinc Sulphate.

S. O. 4674 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(393)  Fixed dose combination of Beclomethasone + Neomycin + Tolnaftate + lodochlorhydroxyquinoline + Chlorocresol.

S. O. 4675 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(394)  Fixed dose combination of Betamethasone + Gentamycin + Zinc Sulphate + Clotrimazole + Chlorocresol.

S. O. 4676 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(395)  Fixed dose combination of Borax + Boric Acid + Naphazoline + Menthol + Camphor + Methyl Hydroxy Benzoate.

S. O. 4677 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(396)  Fixed dose combination of Bromhexine + Dextromethorphan.

S. O. 4678 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(397)  Fixed dose combination of Dextromethorphan + Chlorpheniramine + Bromhexine.

S. O. 4679 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(398)  Fixed dose combination of Menthol + Anesthetic Ether.

S. O. 4680 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(399)  Fixed dose combination of Dextrometharphan + Chlopheniramine + Ammonium Chloride + Sodium Citrate + Menthol.

S. O. 4681 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(400)  Fixed dose combination of Ergotamine Tartrate + Belladona Dry Extract+Caffeine + Paracetamol.

S. O. 4682 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(401)  Fixed dose combination of Gliclazide 40mg + Metformin 400mg.

S. O. 4683 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(402)  Fixed dose combination of Paracetamol + Ambroxol + Phenylephrine + Chlorpheniramine.

S. O. 4684 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(403)  Fixed dose combination of Oflaxacin + Ornidazole Suspension.

S. O. 4685 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(404)  Fixed dose combination of Albuterol + Etofylline + Bromhexine + Menthol Suspension.

S. O. 4686 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(405)  Fixed dose combination of Albuterol + Bromhexine + Theophylline.

S. O. 4687 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(406)  Fixed dose combination of Salbutamol+Hydroxyethyltheophylline (Etofylline) + Bromhexine.

S. O. 4688 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(407)  Fixed dose combination of Paracetamol + Phenylephrine + Levocetirizine +Sodium Citrate.

S. O. 4689 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(408)  Fixed dose combination of Paracetamol + Propyphenazone + Caffeine.

S. O. 4690 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(409)  Fixed dose combination of Guaifenesin + Diphenhydramine + Bromhexine + Phenylephrine.

S. O. 4691 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(410)  Fixed dose combination of Dried Alumnium Hydroxide Gel + Propantheline + Diazepam.

S. O. 4692 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(411)  Fixed dose combination of Bromhexine + Phenylephrine + Chlorpheniramine + Paracetamol.

S. O. 4693 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(412)  Fixed dose combination of Beclomethasone + Clotrimazole + Gentamicin + lodochlorhydroxyquinoline.

S. O. 4694 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(413)  Fixed dose combination of Telmisartan + Metformin.

S. O. 4695 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(414)  Fixed dose combination of Ammonium Citrate + Vitamin B 12 + Folic Acid + Zinc Sulphate.

S. O. 4696 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(415)  Fixed dose combination of Levothyroxine + Pyridoxine + Nicotinamide.

S. O. 4697 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(416)  Fixed dose combination of Benfotiamine + Metformin.

S. O. 4698 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(417)  Fixed dose combination of Thyroid + Thiamine + Riboflavin + Pyridoxine + Calcium Pantothenate + Tocopheryl Acetate + Nicotinamide.

S. O. 4699 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(418)  Fixed dose combination of Ascorbic Acid + Manadione Sodium Bisulphate + Rutin + Dibasic Calcium Phosphate + Adrenochrome mono Semicarbazone.

S. O. 4700 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(419)  Fixed dose combination of Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + Caffeine.

S. O. 4701 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(420)  Fixed dose combination of Clotrimazole + Beclomethasone + Lignocaine + Ofloxacin + Acetic Aicd + Sodium Methyl Paraben + Propyl Parabene.

S. O. 4702 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(421)  Fixed dose combination of Nimesulide + Levocetrizine.

S. O. 4703 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(422)  Fixed dose combination of Ofloxacin + Ornidazole Injection .

S. O. 4704 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(423)  Fixed dose combination of Gemifloxacin + Ambroxol.

S. O. 4705 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(424)  Fixed dose combination of Glucosamine + Ibuprofen.

S. O. 4706 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(425)  Fixed dose combination of Etodolac + Paracetamol.

S. O. 4707 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(426)  Fixed dose combination of Benzoxonium Chloride+Lidocaine subject to conditions.

S. O. 4708 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(427)  Fixed dose combination of Paracetamol + Prochlorperazine Maleate except the strength mentioned in the notification subject to conditions.

S. O. 4709 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(428)  Fixed dose combination of Amoxicillin 250 mg + Potassium Clavulanate Diluted 62.5 mg subject to the condition that the manufacture, sale or distribution of the said drug shall be for suspension only.

S. O. 4710 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(429)  Fixed dose combination of Paracetamol + Prochlorperazine except the strength mentioned in the notification subject to the conditions.

S. O. 4711 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(430)  Fixed dose combination of Glimepiride + Pioglitazone + Metformin except the strength mentioned in the notification subject to the conditions.

S. O. 4712 (E) dtd 07-09-2018 (with effect from 08-09-2018)

(431)  Fixed dose combination of Glibenclamide + Metformin (SR) + Pioglitazone except the strength mentioned in the notification subject to the conditions.

S. O. 6161 (E) dtd 13-12-2018 (with effect from 13-12-2018)

(432)  Manufacture, sale and distribution of Buclizine for the indication “as appetite stimulant”.

S. O. 180 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(433)  Fixed dose combination of 5-bromosalicyl-4-chloranilide + Salicylic acid for human use.

S. O. 181 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(434)  Fixed dose combination of Activated charcoal + Fungal diastase + Lactic acid for human use.

S. O. 182 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(435)  Fixed dose combination of Allobarbitone + Phospho-dimethyl-isopropyl-pyrazolone for human use.

S. O. 183 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(436)  Fixed dose combination of Artesunate + Arteether + Artemether for human use.

S. O. 184 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(437)  Fixed dose combination of Atorvastatin + Acetyl Salicylic acid + Caffeine for human use.

S. O. 185 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(438)  Fixed dose combination of Chlormezanone + Paracetamol + Diclofenac sodium for human use.

S. O. 186 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(439)  Fixed dose combination of Chlormezanone + Paracetamol + Ibuprofen for human use.

S. O. 187 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(440)  Fixed dose of combination of Chlorzoxazone + Ibuprofen + Paracetamol + Diclofenac + Oxyphenbutazone + Magnesium Hydroxide for human use.

S. O. 188 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(441)  Fixed dose combination of Chlorzoxazone + Paracetamol + Ibuprofen + Diclofenac sodium for human use.

S. O. 189 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(442)  Fixed dose combination of Ciprofloxacin + Tinidazole + Dicyclomine for human use.

S. O. 190 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(443)  Fixed dose combination of Dicyclomine + Dextromethorphan + Paracetamol for human use.

S. O. 191 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(444)  Fixed dose combination of Dicyclomine + Paracetamol + Chlordiazepoxide for human use.

S. O. 192 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(445)  Fixed dose combination of Dicyclomine + Paracetamol + Phenylisopropyl Pyrazolone for human use.

S. O. 193 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(446)  Fixed dose combination of Dicyclomine + Serratiopeptidase for human use.

S. O. 194 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(447)  Fixed dose combination of Ibuprofen + Colchicine for human use.

S. O. 195 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(448)  Fixed dose of combination of Ibuprofen + Dextropropoxyphene + Paracetamol for human use.

S. O. 196 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(449)  Fixed dose combination of Ibuprofen + Paracetamol + Colchicine for human use.

S. O. 197 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(450)  Fixed dose combination of Ibuprofen + Paracetamol + Magnesium Trisilicate for human use.

S. O. 198 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(451)  Fixed dose combination of Mebeverine + Alprazolam for human use.

S. O. 199 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(452)  Fixed dose combination of Mecobalamin + Methenamine mandelate for human use.

S. O. 200 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(453)  Fixed dose combination of Norfloxacin + Tinidazole + Dicyclomine for human use.

S. O. 201 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(454)  Fixed dose combination of Norfloxacin + Tinidazole + Loperamide for human use.

S. O. 202 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(455)  Fixed dose combination of Ondansetron + Paracetamol for human use.

S. O. 203 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(456)  Fixed dose of combination of Paracetamol + Alprazolam for human use.

S. O. 204 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(457)  Fixed dose combination of Paracetamol + Diclofenac Sodium + Amoxicillin + Cloxacillin + Pantoprazole + Lactic Acid Bacillus + Serratiopeptidase for human use.

S. O. 205 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(458)  Fixed dose combination of Paracetamol + Diclofenac sodium + Magnesium Trisilicate + Chlorpheniramine Maleate for human use.

S. O. 206 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(459)  Fixed dose of combination of Paracetamol + Ketoprofen + Dextropropoxyphene for human use.

S. O. 207 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(460)  Fixed dose combination of Ranitidine + Dicyclomine + Clidinium Bromide for human use.

S. O. 208 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(461)  Fixed dose combination of Ranitidine + Omeprazole for human use.

S. O. 209 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(462)  Fixed dose combination of Acriflavine + Gentian violet + Brilliant green for human use.

S. O. 210 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(463)  Fixed dose combination of Allantoin + Triclosan + Vitamin E + Zinc Oxide for human use.

S. O. 211 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(464)  Fixed dose combination of Allantoin + Vitamin E + Camellia Sinensis for human use.

S. O. 212 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(465)  Fixed dose combination of Atorvastatin + Omega 3 Fatty Acid 250mg for human use.

S. O. 213 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(466)  Fixed dose combination of Atorvastatin + Ubidecarenone for human use.

S. O. 214 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(467)  Fixed dose combination of Cefixime + Lactobacillus + Clavulanic Acid for human use.

S. O. 215 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(468)  Fixed dose combination of Cefixime + Ornidazole for human use.

S. O. 216 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(469)  Fixed dose combination of Ceftriaxone + Vancomycin for human use.

S. O. 217 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(470)  Fixed dose combination of Cefuroxime + Ornidazole for human use.

S. O. 218 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(471)  Fixed dose combination of Diclofenac + Pitofenone Hydrochloride + Fenpiverinium Bromide + Paracetamol for human use.

S. O. 219 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(472)  Fixed dose combination of Dicyclomine + Paracetamol + Dextropropoxyphene + Chlordiazepoxide for human use.

S. O. 220 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(473)  Fixed dose combination of Dicyclomine + Paracetamol + Dimethylpolysiloxane for human use.

S. O. 221 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(474)  Fixed dose combination of Dicyclomine + Paracetamol + Simethicone for human use.

S. O. 222 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(475)  Fixed dose combination of Doxycycline + Tinidazole for human use.

S. O. 223 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(476)  Fixed dose combination of Drotaverine + Omeprazole for human use.

S. O. 224 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(477)  Fixed dose combination of Fenpiverinium Bromide + Diclofenac Sodium + Pitofenone Hydrochloride for human use.

S. O. 225 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(478)  Fixed dose combination of Glucosamine + Ascorbic Acid for human use.

S. O. 226 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(479)  Fixed dose combination of Glucosamine + Boswellia Serrata for human use.

S. O. 227 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(480)  Fixed dose combination of Glucosamine + Calcium Carbonate for human use.

S. O. 228 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(481)  Fixed dose combination of Glucosamine + Cetyl Myristate Oleate for human use.

S. O. 229 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(482)  Fixed dose combination of Glucosamine + Chondroitin sulphate + Methyl sulfonyl methane for human use.

S. O. 230 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(483)  Fixed dose combination of Glucosamine + Chondroitin sulphate + Vitamin C + Manganese sulphate for human use.

S. O. 231 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(484)  Fixed dose combination of Glucosamine + Chondroitin + Vitamin C + Vitamin E + Manganese for human use.

S. O. 232 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(485)  Fixed dose combination of Glucosamine + Chondroitin + Vitamin C for human use.

S. O. 233 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(486)  Fixed dose combination of Glucosamine + Chondroitin + Vitamin C + Vitamin E + Manganese sulphate + Sodium borate + Selenium dioxide for human use.

S. O. 234 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(487)  Fixed dose combination of Glucosamine + Cholecalciferol + Manganese + Ascorbic acid for human use.

S. O. 235 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(488)  Fixed dose combination of Glucosamine + Manganese for human use.

S. O. 236 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(489)  Fixed dose combination of Glucosamine + Mecobalamin + Dimethyl Sulfone for human use.

S. O. 237 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(490)  Fixed dose combination of Glucosamine + Mecobalamin for human use.

S. O. 238 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(491)  Fixed dose combination of Glucosamine + Mecobalamin + Milk calcium for human use.

S. O. 239 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(492)  Fixed dose combination of Glucosamine + Methyl sulfonyl methane for human use.

S. O. 240 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(493)  Fixed dose combination of Glucosamine + Methyl sulfonyl methane + Cetyl Myristate for human use.

S. O. 241 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(494)  Fixed dose combination of Glucosamine + Vitamin C + Calcium + Methyl Sulfonyl Methane + Chondroitin + Manganese for human use.

S. O. 242 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(495)  Fixed dose combination of Glucosamine + Vitamin C+ Vitamin E + Chondroitin sulphate + Methyl sulfonyl methane + Manganese sulphate for human use.

S. O. 243 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(496)  Fixed dose combination of Glucosamine sulphate + Chondroitin sulphate + Vitamin E + Manganese for human use.

S. O. 244 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(497)  Fixed dose combination of Glucosamine + Calcium + Vitamin D3 for human use.

S. O. 245 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(498)  Fixed dose of combination of Ornidazole + Doxycycline for human use.

S. O. 246 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(499)  Fixed dose combination of Ornidazole + Fluconazole + Azithromycin for human use.

S. O. 247 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(500)  Fixed dose combination of Propranolol + Hydralazine for human use.

S. O. 248 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(501)  Fixed dose combination of Propranolol + Hydrochlorothiazide + Dihydralazine for human use.

S. O. 249 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(502)  Fixed dose combination of Ranitidine + Dicyclomine + Nimesulide for human use.

S. O. 250 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(503)  Fixed dose of combination of Ranitidine + Dicycloverine + Simethicone for human use.

S. O. 251 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(504)  Fixed dose combination of Ranitidine + Drotaverine for human use.

S. O. 252 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(505)  Fixed dose combination of Telmisartan + Ramipril + Hydrochlorothiazide for human use.

S. O. 253 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(506)  Fixed dose combination of Ibuprofen + Paracetamol + Phenylephrine + Chlorpheniramine maleate for human use.

S. O. 254 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(507)  Fixed dose combination of Nimesulide + Phenylephrine + Chlorpheniramine maleate + Caffeine for human use.

S. O. 255 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(508)  Fixed dose of combination of Nimesulide + Pitofenone + Fenpiverinium Bromide for human use.

S. O. 256 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(509)  Fixed dose combination of Nimesulide+ Pseudoephedrine + Cetirizine for human use.

S. O. 257 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(510)  Fixed dose combination of Ofloxacin + Diclofenac + Lignocaine with immediate effect.

S. O. 258 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(511)  Fixed dose of combination of Ondansetron + Omeprazole for human use.

S. O. 259 (E) dtd 11-01-2019 (with effect from 11-01-2019)

(512)  Fixed dose combination of Hydrochlorothiazide + Ramipril + Losartan Potassium for human use.

S. O. 2607 (E) dtd 19-07-2019 (with effect from 19-07-2019)

(513)  "Colistin and its formulations for food producing animals, poultry, aqua farming and animal feed supplements"; and directs that the manufacturer of Colistin and its formulations shall label the container of the drug and mention the words “NOT TO BE USED IN FOOD PRODUCING ANIMALS, POULTRY, AQUA FARMING AND ANIMAL FEED SUPPLEMENTS” in conspicuous manner on the package insert and promotional literature of the said drug and its formulations.

S. O. 2394 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(514)  Fixed dose combination of Nimesulide + Paracetamol dispersible tablets for human use.

S. O. 2395 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(515)  Fixed dose combination of Amoxicillin+ Bromhexine for human use.

S. O. 2396 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(516)  Fixed dose combination of Pholcodine + Promethazine for human use.

S. O. 2397 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(517)  Fixed dose combination of Chlorpheniramine maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol for human use.

S. O. 2398 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(518)  Fixed dose combination of Chlopheniramine Maleate + Codeine Syrup for human use.

S. O. 2399 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(519)  Fixed dose combination of Ammomium Chloride + Bromhexine + Dextromethorphan for human use.

S. O. 2400 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(520)  Fixed dose combination of Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol for human use.

S. O. 2401 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(521)  Fixed dose combination of Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride for human use.

S. O. 2402 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(522)  Fixed dose combination of Paracetamol + Bromhexine+ Phenylephrine + Chlorpheniramine + Guaiphenesin for human use.

S. O. 2403 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(523)  Fixed dose combination of Salbutamol + Bromhexine for human use.

S. O. 2404 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(524)  Fixed dose combination of Chlorpheniramine + Codeine Phosphate + Menthol Syrup for human use.

S. O. 2405 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(525)  Fixed dose combination of Phenytoin + Phenobarbitone sodium for human use.

S. O. 2406 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(526)  Fixed dose combination of Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (100mg + 40mg + 2.5mg + 0.9mg), (125mg + 55mg + 4mg + 1mg), (110mg + 46mg + 3mg + 0.9mg) & (130mg + 55mg + 3mg + 0.5mg) per 5ml syrup for human use.

S. O. 2407 (E) dtd 02-06-2023 (with effect from 02-06-2023)

(527)  Fixed dose combination of Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine for human use.

S. O. 3448(E) dtd 31-07-2023 (with effect from 01-08-2023)

(528)  (i) Ketoprofen and its formulations for animal use  (ii) Aceclofenac and its formulations for animal use.

S. O. 3266(E) dtd 12-08-2024 (with effect from 12-08-2024)

(529)  FDC of Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate IP 20mg Capsule or Tablet shall be subject to conditions (i) to (iii) mentioned in the notification.

S. O. 3267(E) dtd 12-08-2024 (with effect from 12-08-2024)

(530)  FDC of Naproxen IP 250/500mg + Pantoprazole IP 20mg hard gelatin Capsules or Tablets shall be subject to conditions (i) to (iv) mentioned in the notification.

S.O. 3284(E) dtd 12-08-2024 (with effect from 12-08-2024)

(531)  Fixed dose combination of S(+) Etodolac + Paracetamol for human use.

S.O. 3285(E) dtd 02-08-2024 (with effect from 12-08-2024)

(532)  Fixed dose combination of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain for human use.

S.O. 3286(E) dtd 02-08-2024 (with effect from 12-08-2024)

(533)  Fixed dose combination of Antimony Potassium Tartrate + Dried Ferrous Sulphate for human use.

S.O. 3287(E) dtd 02-08-2024 (with effect from 12-08-2024)

(534)  Fixed dose combination of Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride for human use.

S.O. 3288(E) dtd 02-08-2024 (with effect from 12-08-2024)

(535)  Fixed dose combination of Bismuth Ammonium Citrate + Papain for human use.

S.O. 3289(E) dtd 02-08-2024 (with effect from 12-08-2024)

(536)  Fixed dose combination of Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide for human use.

S.O. 3290(E) dtd 02-08-2024 (with effect from 12-08-2024)

(537)  Fixed dose combination of Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride for human use.

S.O. 3291(E) dtd 02-08-2024 (with effect from 12-08-2024)

(538)  Fixed dose combination of Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide for human use.

S.O. 3292(E) dtd 02-08-2024 (with effect from 12-08-2024)

(539)  Fixed dose combination of Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol for human use.

S.O. 3293(E) dtd 02-08-2024 (with effect from 12-08-2024)

(540)  Fixed dose combination of Mefenamic Acid + Paracetamol Injection for human use.

S.O. 3294(E) dtd 02-08-2024 (with effect from 12-08-2024)

(541)  Fixed dose combination of Omeprazole Magnesium + Dicyclomine HCl for human use.

S.O. 3295(E) dtd 02-08-2024 (with effect from 12-08-2024)

(542)  Fixed dose combination of S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L-Methylfolate + Choline bitartratee + Silymarin + L-ornithine L-aspartate + Inositol + Taurine for human use.

S.O. 3296(E) dtd 02-08-2024 (with effect from 12-08-2024)

(543)  Fixed dose combination of Silymarin + Thiamine Mononitrate + Riboflavin+ Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 for human use.

S.O. 3297(E) dtd 02-08-2024 (with effect from 12-08-2024)

(544)  Fixed dose combination of Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid for human use.

S.O. 3298(E) dtd 02-08-2024 (with effect from 12-08-2024)

(545)  Fixed dose combination of Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate for human use.

S.O. 3299(E) dtd 02-08-2024 (with effect from 12-08-2024)

(546)  Fixed dose combination of Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol for human use.

S.O. 3300(E) dtd 02-08-2024 (with effect from 12-08-2024)

(547)  Fixed dose combination of Sucralfate + Acelofenac for human use.

S.O. 3301(E) dtd 02-08-2024 (with effect from 12-08-2024)

(548)  Fixed dose combination of Sucralfate + Domperidone + Dimethicone for human use.

S.O. 3302(E) dtd 02-08-2024 (with effect from 12-08-2024)

(549)  Fixed dose combination of Sucralfate + Domperidone for human use.

S.O. 3303(E) dtd 02-08-2024 (with effect from 12-08-2024)

(550)  Fixed dose combination of Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol for human use.

S.O. 3304(E) dtd 02-08-2024 (with effect from 12-08-2024)

(551)  Fixed dose combination of Ursodeoxycholic Acid + Metformin HCl for human use.

S.O. 3305(E) dtd 02-08-2024 (with effect from 12-08-2024)

(552)  Fixed dose combination of Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit +Chloroform +Sodium Bicarbonate +Compound Cardamom + Alcohol for human use.

S.O. 3306(E) dtd 02-08-2024 (with effect from 12-08-2024)

(553)  Fixed dose combination of Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate for human use.

S.O. 3307(E) dtd 02-08-2024 (with effect from 12-08-2024)

(554)  Fixed dose combination of Aloe + Vitamin E Soap for human use.

S.O. 3308(E) dtd 02-08-2024 (with effect from 12-08-2024)

(555)  Fixed dose combination of Povidone Iodine + Metronidazole + Aloe for human use.

S.O. 3309(E) dtd 02-08-2024 (with effect from 12-08-2024)

(556)  Fixed dose combination of Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles for human use.

S.O. 3310(E) dtd 02-08-2024 (with effect from 12-08-2024)

(557)  Fixed dose combination of Azithromycin + Adapalene for human use.

S.O. 3311(E) dtd 02-08-2024 (with effect from 12-08-2024)

(558)  Fixed dose combination of Calamine + Aloes + Allantoin for human use.

S.O. 3312(E) dtd 02-08-2024 (with effect from 12-08-2024)

(559)  Fixed dose combination of Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor for human use.

S.O. 3313(E) dtd 02-08-2024 (with effect from 12-08-2024)

(560)  Fixed dose combination of Chlorphenesin + Zinc oxide + Starch for human use.

S.O. 3314(E) dtd 02-08-2024 (with effect from 12-08-2024)

(561)  Fixed dose combination of Clindamycin Phosphate + Zinc acetate for human use.

S.O. 3315(E) dtd 02-08-2024 (with effect from 12-08-2024)

(562)  Fixed dose combination of Gamma Benzene Hexachloride + Benzocaine for human use.

S.O. 3316(E) dtd 02-08-2024 (with effect from 12-08-2024)

(563)  Fixed dose combination of Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin for human use.

S.O. 3317(E) dtd 02-08-2024 (with effect from 12-08-2024)

(564)  Fixed dose combination of Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w for human use.

S.O. 3318(E) dtd 02-08-2024 (with effect from 12-08-2024)

(565)  Fixed dose combination of Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes for human use.

S.O. 3319(E) dtd 02-08-2024 (with effect from 12-08-2024)

(566)  Fixed dose combination of Ketoconazole +Aloe vera+ Vitamin A Acetate for human use.

S.O. 3320(E) dtd 02-08-2024 (with effect from 12-08-2024)

(567)  Fixed dose combination of Ketoconazole +Aloes + ZPTO for human use.

S.O. 3321(E) dtd 02-08-2024 (with effect from 12-08-2024)

(568)  Fixed dose combination of Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry for human use.

S.O. 3322(E) dtd 02-08-2024 (with effect from 12-08-2024)

(569)  Fixed dose combination of Lornoxicam + capsaicin + menthol + camphor for human use.

S.O. 3323(E) dtd 02-08-2024 (with effect from 12-08-2024)

(570)  Fixed dose combination of Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate for human use.

S.O. 3324(E) dtd 02-08-2024 (with effect from 12-08-2024)

(571)  Fixed dose combination of Menthol + Aloe vera Topical Spray for human use.

S.O. 3325(E) dtd 02-08-2024 (with effect from 12-08-2024)

(572)  Fixed dose combination of Menthol + Lignocaine HCl+Aloe vera gel + Clotrimazole + Diphenhydramine for human use.

S.O. 3326(E) dtd 02-08-2024 (with effect from 12-08-2024)

(573)  Fixed dose combination of Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate for human use.

S.O. 3327(E) dtd 02-08-2024 (with effect from 12-08-2024)

(574)  Fixed dose combination of Miconazole +Tinidazole for human use.

S.O. 3328(E) dtd 02-08-2024 (with effect from 12-08-2024)

(575)  Fixed dose combination of Minoxidil +Aminexil + Alcohol for human use.

S.O. 3329(E) dtd 02-08-2024 (with effect from 12-08-2024)

(576)  Fixed dose combination of Minoxidil +Azelaic acid + saw palmetto for human use.

S.O. 3330(E) dtd 02-08-2024 (with effect from 12-08-2024)

(577)  Fixed dose combination of Minoxidil +Aminexil for human use.

S.O. 3331(E) dtd 02-08-2024 (with effect from 12-08-2024)

(578)  Fixed dose combination of Pine Bark extract + Kojic acid + Sodium Ascorbyl Phosphate for human use.

S.O. 3332(E) dtd 02-08-2024 (with effect from 12-08-2024)

(579)  Fixed dose combination of Povidone Iodine + Tinidazole + Zinc sulphate for human use.

S.O. 3333(E) dtd 02-08-2024 (with effect from 12-08-2024)

(580)  Fixed dose combination of Povidone Iodine + Ornidazole + Dexpanthenol for human use.

S.O. 3334(E) dtd 02-08-2024 (with effect from 12-08-2024)

(581)  Fixed dose combination of Salicyclic acid + Aloe vera + Allantoin + D-Panthenol for human use.

S.O. 3335(E) dtd 02-08-2024 (with effect from 12-08-2024)

(582)  Fixed dose combination of Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate for human use.

S.O. 3336(E) dtd 02-08-2024 (with effect from 12-08-2024)

(583)  Fixed dose combination of Sodium salicylate + Zinc gluconate + Pyridoxine HCl for human use.

S.O. 3337(E) dtd 02-08-2024 (with effect from 12-08-2024)

(584)  Fixed dose combination of Tetracycline + Colistin Sulphate for human use.

S.O. 3338(E) dtd 02-08-2024 (with effect from 12-08-2024)

(585)  Fixed dose combination of Clomiphene + Ubidecarenone for human use.

S.O. 3339(E) dtd 02-08-2024 (with effect from 12-08-2024)

(586)  Fixed dose combination of Combikit Clomiphene Citrate + Estradiol Valerate for human use.

S.O. 3340(E) dtd 02-08-2024 (with effect from 12-08-2024)

(587)  Fixed dose combination of Flavoxate HCl + Ofloxacin for human use.

S.O. 3341(E) dtd 02-08-2024 (with effect from 12-08-2024)

(588)  Fixed dose combination of Clomiphene Citrate + N-Acetylcysteine for human use.

S.O. 3342(E) dtd 02-08-2024 (with effect from 12-08-2024)

(589)  Fixed dose combination of Evening Primerose Oil +Cod liver oil for human use.

S.O. 3343(E) dtd 02-08-2024 (with effect from 12-08-2024)

(590)  Fixed dose combination of Sildenafil Citrate +Papaverine +L-Arginine for human use.

S.O. 3344(E) dtd 02-08-2024 (with effect from 12-08-2024)

(591)  Fixed dose combination of Tranexamic acid + Mefenamic acid + Vitamin K1 for human use.

S.O. 3345(E) dtd 02-08-2024 (with effect from 12-08-2024)

(592)  Fixed dose combination of Divalproex Sodium +Oxcarbazepine for human use.

S.O. 3346(E) dtd 02-08-2024 (with effect from 12-08-2024)

(593)  Fixed dose combination of Divalproex Sodium +Levetiracitam for human use.

S.O. 3347(E) dtd 02-08-2024 (with effect from 12-08-2024)

(594)  Fixed dose combination of Ergotamine tartrate + Caffeine + Paracetamol + Prochlorperazine maleate for human use.

S.O. 3348(E) dtd 02-08-2024 (with effect from 12-08-2024)

(595)  Fixed dose combination of Piracetam + Ginkgo biloba extracts + Vinpocetin for human use.

S.O. 3349(E) dtd 02-08-2024 (with effect from 12-08-2024)

(596)  Fixed dose combination of Ginkgo biloba + methylcobalamin for human use.

S.O. 3350(E) dtd 02-08-2024 (with effect from 12-08-2024)

(597)  Fixed dose combination of Ginkgo biloba + methylcobalamin + Alpha lipoic acid + Pyridoxine HCl for human use.

S.O. 3351(E) dtd 02-08-2024 (with effect from 12-08-2024)

(598)  Fixed dose combination of Ginseng Extract + Dried extract of Ginkgo Biloba for human use.

S.O. 3352(E) dtd 02-08-2024 (with effect from 12-08-2024)

(599)  Fixed dose combination of Meclizine HCl+ Paracetamol + Caffeine for human use.

S.O. 3353(E) dtd 02-08-2024 (with effect from 12-08-2024)

(600)  Fixed dose combination of Nicergoline + Vinpocetine for human use.

S.O. 3354(E) dtd 02-08-2024 (with effect from 12-08-2024)

(601)  Fixed dose combination of Gamma Linolenic Acid + Methylcobalamin for human use.

S.O. 3355(E) dtd 02-08-2024 (with effect from 12-08-2024)

(602)  Fixed dose combination of Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl for human use.

S.O. 3356(E) dtd 02-08-2024 (with effect from 12-08-2024)

(603)  Fixed dose combination of Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor for human use.

S.O. 3357(E) dtd 02-08-2024 (with effect from 12-08-2024)

(604)  Fixed dose combination of Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose for human use.

S.O. 3358(E) dtd 02-08-2024 (with effect from 12-08-2024)

(605)  Fixed dose combination of Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose for human use.

S.O. 3359(E) dtd 02-08-2024 (with effect from 12-08-2024)

(606)  Fixed dose combination of Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose for human use.

S.O. 3360(E) dtd 02-08-2024 (with effect from 12-08-2024)

(607)  Fixed dose combination of Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl for human use.

S.O. 3361(E) dtd 02-08-2024 (with effect from 12-08-2024)

(608)  Fixed dose combination of Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine for human use.

S.O. 3362(E) dtd 02-08-2024 (with effect from 12-08-2024)

(609)  Fixed dose combination of Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose for human use.

S.O. 3363(E) dtd 02-08-2024 (with effect from 12-08-2024)

(610)  Fixed dose combination of Ketorolac Tromethamine + Flurometholone for human use.

S.O. 3364(E) dtd 02-08-2024 (with effect from 12-08-2024)

(611)  Fixed dose combination of Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate for human use.

S.O. 3365(E) dtd 02-08-2024 (with effect from 12-08-2024)

(612)  Fixed dose combination of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor for human use.

S.O. 3366(E) dtd 02-08-2024 (with effect from 12-08-2024)

(613)  Fixed dose combination of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid + Sodium Chloride + Zinc Sulphate for human use.

S.O. 3367(E) dtd 02-08-2024 (with effect from 12-08-2024)

(614)  Fixed dose combination of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid for human use.

S.O. 3368(E) dtd 02-08-2024 (with effect from 12-08-2024)

(615)  Fixed dose combination of Naphazoline HCl + Chlorpheniramine Maleate + Methyl Cellulose for human use.

S.O. 3369(E) dtd 02-08-2024 (with effect from 12-08-2024)

(616)  Fixed dose combination of Naphazoline HCl + Hydroxy Methyl Cellulose + Boric Acid + Menthol + Camphor for human use.

S.O. 3370(E) dtd 02-08-2024 (with effect from 12-08-2024)

(617)  Fixed dose combination of Naphazoline HCl + Boric Acid+Menthol+Camphor +Methyl Cellulose + Chlorpheniramine Maleate + Zinc Sulphate + Sodium Chloride for human use.

S.O. 3371(E) dtd 02-08-2024 (with effect from 12-08-2024)

(618)  Fixed dose combination of Naphazoline HCl + Phenylephrine HCl+ HPMC + Chlorpheniramine Maleate + Menthol+ Camphor for human use.

S.O. 3372(E) dtd 02-08-2024 (with effect from 12-08-2024)

(619)  Fixed dose combination of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid + Sodium Chloride + Zinc Sulphate + Menthol + Camphor for human use.

S.O. 3373(E) dtd 02-08-2024 (with effect from 12-08-2024)

(620)  Fixed dose combination of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid +Zinc Sulphate for human use.

S.O. 3374(E) dtd 02-08-2024 (with effect from 12-08-2024)

(621)  Fixed dose combination of Naphazoline HCl + Azelastine HCl+ Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex for human use.

S.O. 3375(E) dtd 02-08-2024 (with effect from 12-08-2024)

(622)  Fixed dose combination of Naphazoline HCl + Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex for human use.

S.O. 3376(E) dtd 02-08-2024 (with effect from 12-08-2024)

(623)  Fixed dose combination of Naphazoline Nitrate + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Methyl Cellulose + Boric Acid+ Menthol+ Camphor for human use.

S.O. 3377(E) dtd 02-08-2024 (with effect from 12-08-2024)

(624)  Fixed dose combination of Naphazoline Nitrate + Chlorpheniramine Maleate + Zinc Sulphate + Boric Acid + Sodium Chloride for human use.

S.O. 3378(E) dtd 02-08-2024 (with effect from 12-08-2024)

(625)  Fixed dose combination of Norfloxacin + Tinidazole (with Betacyclodextrin) Eye ointment for human use.

S.O. 3379(E) dtd 02-08-2024 (with effect from 12-08-2024)

(626)  Fixed dose combination of Ofloxacin + Beclomethasone Dipropionate + Lignocaine HCl for human use.

S.O. 3380(E) dtd 02-08-2024 (with effect from 12-08-2024)

(627)  Fixed dose combination of Naphazoline HCl + Chlorpheniramine Maleate + Phenylephrine HCl+ Menthol+ Camphor for human use.

S.O. 3381(E) dtd 02-08-2024 (with effect from 12-08-2024)

(628)  Fixed dose combination of Phenylephrine HCl + Naphazoline HCl +Menthol+ Camphor + Hydroxy Propyl Methyl Cellulose for human use.

S.O. 3382(E) dtd 02-08-2024 (with effect from 12-08-2024)

(629)  Fixed dose combination of Phenylephrine HCl + Naphazoline HCl + Menthol + Camphor for human use.

S.O. 3383(E) dtd 02-08-2024 (with effect from 12-08-2024)

(630)  Fixed dose combination of Sulphacetamide Sodium + Zinc Sulphate + Chlorpheniramine Maleate + Boric acid + Sodium Chloride for human use.

S.O. 3384(E) dtd 02-08-2024 (with effect from 12-08-2024)

(631)  Fixed dose combination of Zinc Sulphate + Boric acid + Naphazoline HCl + Sodium Chloride + Phenyl Ethyl Alcohol for human use.

S.O. 3385(E) dtd 02-08-2024 (with effect from 12-08-2024)

(632)  Fixed dose combination of Cetirizine HCl + Paracetamol + Phenylephrine HCl for human use.

S.O. 3386(E) dtd 02-08-2024 (with effect from 12-08-2024)

(633)  Fixed dose combination of Cetirizine HCl + Phenylephrine HCl for human use.

S.O. 3387(E) dtd 02-08-2024 (with effect from 12-08-2024)

(634)  Fixed dose combination of Levocetirizine + Phenylephrine HCl for human use.

S.O. 3388(E) dtd 02-08-2024 (with effect from 12-08-2024)

(635)  Fixed dose combination of Levocetirizine + Phenylephrine HCl + Paracetamol for human use.

S.O. 3389(E) dtd 02-08-2024 (with effect from 12-08-2024)

(636)  Fixed dose combination of Phenylephrine HCl + Paracetamol + Levocetirizine HCl + Menthol for human use.

S.O. 3390(E) dtd 02-08-2024 (with effect from 12-08-2024)

(637)  Fixed dose combination of Levocetirizine HCl + Ambroxol HCl + Paracetamol for human use.

S.O. 3391(E) dtd 02-08-2024 (with effect from 12-08-2024)

(638)  Fixed dose combination of Levocetirizine HCl + Ambroxol HCl + Phenylephrine HCl for human use.

S.O. 3392(E) dtd 02-08-2024 (with effect from 12-08-2024)

(639)  Fixed dose combination of Diethylcarbamazine Citrate + Chlorpheniramine maleate for human use.

S.O. 3393(E) dtd 02-08-2024 (with effect from 12-08-2024)

(640)  Fixed dose combination of Diethylcarbamazine Citrate + Levocetirizine HCl for human use.

S.O. 3394(E) dtd 02-08-2024 (with effect from 12-08-2024)

(641)  Fixed dose combination of Ambroxol HCl + Phenylephrine HCl + Guaiphenesin for human use.

S.O. 3395(E) dtd 02-08-2024 (with effect from 12-08-2024)

(642)  Fixed dose combination of Bromhexine HCl + Phenylephrine HCl for human use.

S.O. 3396(E) dtd 02-08-2024 (with effect from 12-08-2024)

(643)  Fixed dose combination of Etofylline + Theophylline anhydrous eq. to Theophylline hydrate + Ambroxol HCl for human use.

S.O. 3397(E) dtd 02-08-2024 (with effect from 12-08-2024)

(644)  Fixed dose combination of Etofylline + Theophylline anhydrous eq. to Theophylline hydrate + Montelukast for human use.

S.O. 3398(E) dtd 02-08-2024 (with effect from 12-08-2024)

(645)  Fixed dose combination of Ambroxol HCl + Terbutaline Sulphate + Ammonium Chloride + Guaiphenesin + Menthol for human use.

S.O. 3399(E) dtd 02-08-2024 (with effect from 12-08-2024)

(646)  Fixed dose combination of Ambroxol HCl + Salbutamol Sulphate + Ammonium Chloride + Guaiphenesin + Menthol for human use.

S.O. 3400(E) dtd 02-08-2024 (with effect from 12-08-2024)

(647)  Fixed dose combination of Cetirizine HCl + Terbutaline Sulphate + Ambroxol HCl + Guaiphenesin for human use.

S.O. 3401(E) dtd 02-08-2024 (with effect from 12-08-2024)

(648)  Fixed dose combination of Dextromethorphan Hydrobromide + Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate + Menthol for human use.

S.O. 3402(E) dtd 02-08-2024 (with effect from 12-08-2024)

(649)  Fixed dose combination of Salbutamol Sulphate + Bromhexine HCl + Guaiphenesin + Ammonium Chloride + Menthol for human use.

S.O. 3403(E) dtd 02-08-2024 (with effect from 12-08-2024)

(650)  Fixed dose combination of Terbutaline Sulphate + Bromhexine HCl + Chlorpheniramine Maleate for human use.

S.O. 3404(E) dtd 02-08-2024 (with effect from 12-08-2024)

(651)  Fixed dose combination of Chlorpheniramine Maleate + P.G Sulphonate + Ammonium Chloride + Sodium Citrate + Menthol for human use.

S.O. 3405(E) dtd 02-08-2024 (with effect from 12-08-2024)

(652)  Fixed dose combination of Aminophylline + Ammonium Chloride + Sodium Citrate for human use.

S.O. 3406(E) dtd 02-08-2024 (with effect from 12-08-2024)

(653)  Fixed dose combination of Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine for human use.

S.O. 3407(E) dtd 02-08-2024 (with effect from 12-08-2024)

(654)  Fixed dose combination of Trithioparamethoxyphenyl Propene + Chlorpheniramine Maleate for human use.

S.O. 3408(E) dtd 02-08-2024 (with effect from 12-08-2024)

(655)  Fixed dose combination of Aceclofenac 50mg + Paracetamol 125mg oral liquid for human use.

S.O. 3409(E) dtd 02-08-2024 (with effect from 12-08-2024)

(656)  Fixed dose combination of Aceclofenac 50mg + Paracetamol 125mg tablet for human use.

S.O. 3410(E) dtd 02-08-2024 (with effect from 12-08-2024)

(657)  Fixed dose combination of Adenosine triphosphate diphosphate + Magnesium Orotate for human use.

S.O. 3411(E) dtd 02-08-2024 (with effect from 12-08-2024)

(658)  Fixed dose combination of Amoxicillin Trihydrate + Dicloxacillin Sodium + Lactobacillus for human use.

S.O. 3412(E) dtd 02-08-2024 (with effect from 12-08-2024)

(659)  Fixed dose combination of Camylofin Dihydrochloride 25 mg + Paracetamol 300mg for human use.

S.O. 3413(E) dtd 02-08-2024 (with effect from 12-08-2024)

(660)  Fixed dose combination of Cefixime + Acetyl Cysteine for human use.

S.O. 3414(E) dtd 02-08-2024 (with effect from 12-08-2024)

(661)  Fixed dose combination of Cephalexin Monohydrate + Serratiopeptidase for human use.

S.O. 3415(E) dtd 02-08-2024 (with effect from 12-08-2024)

(662)  Fixed dose combination of Cetyl Myristoleate + glucosamine Sulphate Potassium+ Methyl Sulfonyl methane for human use.

S.O. 3416(E) dtd 02-08-2024 (with effect from 12-08-2024)

(663)  Fixed dose combination of Diacerin IP + Glucosamine Sulphate Potassium Chloride USP + MSM (Methylsulphonyl Methane) + Cetyl Myristoleate for human use.

S.O. 3417(E) dtd 02-08-2024 (with effect from 12-08-2024)

(664)  Fixed dose combination of Paracetamol + Diclofenac Potassium + Caffeine Anhydrous for human use.

S.O. 3418(E) dtd 02-08-2024 (with effect from 12-08-2024)

(665)  Fixed dose combination of Diclofenac sodium + Thiocolchicoside Injection for human use.

S.O. 3419(E) dtd 02-08-2024 (with effect from 12-08-2024)

(666)  Fixed dose combination of Doxycycline + Ornidazole + Bromelain + Lactobacillus Rhamnosus + Lactobacillus Reuteri RC for human use.

S.O. 3420(E) dtd 02-08-2024 (with effect from 12-08-2024)

(667)  Fixed dose combination of Doxycycline HCl + Betacyclodextrin + Serratiopeptidase for human use.

S.O. 3421(E) dtd 02-08-2024 (with effect from 12-08-2024)

(668)  Fixed dose combination of Erythromycin stearate eq.to Erythromycin +Lactic acid Bacillus for human use.

S.O. 3422(E) dtd 02-08-2024 (with effect from 12-08-2024)

(669)  Fixed dose combination of Etodolac + Paracetamol +Serratiopeptidase for human use.

S.O. 3423(E) dtd 02-08-2024 (with effect from 12-08-2024)

(670)  Fixed dose combination of Flupirtine Maleate 400 mg + Paracetamol 325 mg tablet for human use.

S.O. 3424(E) dtd 02-08-2024 (with effect from 12-08-2024)

(671)  Fixed dose combination of Glucosamine sulphate potassium chloride 410 mg + Chondroitin Sulphate 100 mg for human use.

S.O. 3425(E) dtd 02-08-2024 (with effect from 12-08-2024)

(672)  Fixed dose combination of Glucosamine sulphate potassium chloride+ Methyl Sulphonyl Methane(MSM) + Sodium Borate + Copper Sulphate pentahydrate+ Manganese Sulphate + Vitamin D3 for human use.

S.O. 3426(E) dtd 02-08-2024 (with effect from 12-08-2024)

(673)  Fixed dose combination of Glucosamine Sulphate Sodium Chloride +Manganese +Boron + Zinc + Copper for human use.

S.O. 3427(E) dtd 02-08-2024 (with effect from 12-08-2024)

(674)  Fixed dose combination of Glucosamine sulphate + Chondroitin sulphate + Methylsulfonylmethane +Vitamin D3 + Vitamin E + Vitamin C + Selenium +Elemental Zinc +Elemental Manganese + Elemental Chromium + Elemental Copper + Elemental Boron for human use.

S.O. 3428(E) dtd 02-08-2024 (with effect from 12-08-2024)

(675)  Fixed dose combination of Glucosamine sulphate + Methyl sufonyl methane + manganese sulphate +Vit E acetate +calcium Carbonate for human use.

S.O. 3429(E) dtd 02-08-2024 (with effect from 12-08-2024)

(676)  Fixed dose combination of Glucosamine Sulphate + +Vitamin E acetate + Calcium Pantothenate + Vitamin D3 for human use.

S.O. 3430(E) dtd 02-08-2024 (with effect from 12-08-2024)

(677)  Fixed dose combination of Glucosamine Sulphate Potassium chloride +Calcium Carbonate from an organic source (oyster shell) eq. to elemental Calcium+ Vitamin D3 for human use.

S.O. 3431(E) dtd 02-08-2024 (with effect from 12-08-2024)

(678)  Fixed dose combination of Cetyl Myristoleate + Glucosamine Sulphate Potassium chloride + Methyl sulfonyl methane for human use.

S.O. 3432(E) dtd 02-08-2024 (with effect from 12-08-2024)

(679)  Fixed dose combination of Glucosamine Sulphate Potassium chloride + Methyl sulfonyl methane +Calcium carbonate +Vitamin E+ Manganese for human use.

S.O. 3433(E) dtd 02-08-2024 (with effect from 12-08-2024)

(680)  Fixed dose combination of Glucosamine Sulphate Potassium chloride + Calcium carbonate + Methyl sulfonyl methane +Vit D3 for human use.

S.O. 3434(E) dtd 02-08-2024 (with effect from 12-08-2024)

(681)  Fixed dose combination of Glucosamine Sulphate Potassium + Methyl sulphate Sodium+ Sulphonyl Methane +Chondroitin Sulphate Sodium+ Calcium Carbonate +Vitamin D3+Sodium Borate+ Cupric Oxide+ Colloidal Silicon Dioxide + Manganese Chloride for human use.

S.O. 3435(E) dtd 02-08-2024 (with effect from 12-08-2024)

(682)  Fixed dose combination of Methocarbamol + Diclofenac Sodium Injection for human use.

S.O. 3436(E) dtd 02-08-2024 (with effect from 12-08-2024)

(683)  Fixed dose combination of Paracetamol + Pentazocin for human use.

S.O. 3437(E) dtd 02-08-2024 (with effect from 12-08-2024)

(684)  Fixed dose combination of Sucralfate +Domperidone+ Simethicone for human use.

S.O. 3438(E) dtd 02-08-2024 (with effect from 12-08-2024)

(685)  Fixed dose combination of Sulfaquinoxaline +Diaveridine HCl+ Vitamin K for human use.

S.O. 3439(E) dtd 02-08-2024 (with effect from 12-08-2024)

(686)  Fixed dose combination of Tramadol HCl +Dicyclomine HCl + Domperidone for human use.

S.O. 3440(E) dtd 02-08-2024 (with effect from 12-08-2024)

(687)  Fixed dose combination of Tramadol HCl +Paracetamol +Caffeine +Taurine for human use.

In addition to the above-mentioned drugs, manufacture and sale of all Cosmetics and all Ayurvedic Drugs licensed as toothpaste, tooth powders containing tobacco have been prohibited under G.S.R. 443 (E) and 444(E) dated 30.4.92

*Quashed by Hon'ble High Court of Madras in Cipla Ltd vs UoI matter, W.P.No.7458 of 2011 & M.P.Nos.2, 3 and 4 of 2011, D/j 09.09.2011

¢Corrected wide GSR 590 (E) dtd 30.8.2013

ƫProhibition was revoked with following conditions vide G.S.R. No. 367 (E) dtd 13-04-2017:-

(a)  “Use of drug for cancer pain only.”; and

(i)  “Daily administered dose shall not exceed 300mg. per day.”. (ii)  The formulations meant for veterinary use shall be sold to the veterinary hospitals only.

(b)  the container of the medicine containing dextropropoxyphene shall be labelled with the following words,-

(i)  “Use of drug for cancer pain only.”; and (ii)  “Daily administered dose shall not exceed 300mg. per day”.

(c)  the manufacturer shall advise the registered medical practitioners to administer or prescribe the said drug and its formulations for use in patients with cancer pain only.

Earlier item No. 14 was substituted vide G.S.R. No. 1057 (E) dtd 03-11-1988 'Fixed dose combinations of Corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers'.

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