Drug information for PROMETHAZINE HYDROCHLORIDE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 25MG/ML Prescription AP  PROMETHAZINE HYDROCHLORIDE Promethazine HOSPIRA 40372
2004-06-14 Label

2003-07-31 Review

2000-06-08 Letter
INJECTABLE; INJECTION 50MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine HOSPIRA   "
INJECTABLE; INJECTION 25MG/ML Prescription AP (Reference Drug) PROMETHAZINE HYDROCHLORIDE Promethazine TEVA PARENTERAL 40454
2011-02-15 Review

2007-07-06 Review

2003-04-09 Letter
INJECTABLE; INJECTION 50MG/ML Prescription AP (Reference Drug) PROMETHAZINE HYDROCHLORIDE Promethazine TEVA PARENTERAL   "
INJECTABLE; INJECTION 25MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine BIONICHE PHARMA 40471
INJECTABLE; INJECTION 25MG/ML Prescription AP  PROMETHAZINE HYDROCHLORIDE Promethazine LUITPOLD 40515
INJECTABLE; INJECTION 25MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine BEDFORD LABS 40524
INJECTABLE; INJECTION 50MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine BEDFORD LABS   "
INJECTABLE; INJECTION 25MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine SANDOZ 40593
INJECTABLE; INJECTION 50MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine SANDOZ   "
INJECTABLE; INJECTION 25MG/ML Prescription AP  PROMETHAZINE HYDROCHLORIDE Promethazine X-GEN PHARMS 40737
2008-05-02 Other Important Information from FDA
INJECTABLE; INJECTION 50MG/ML Prescription AP  PROMETHAZINE HYDROCHLORIDE Promethazine X-GEN PHARMS   "
INJECTABLE; INJECTION 25MG/ML Prescription AP  PROMETHAZINE HYDROCHLORIDE Promethazine WOCKHARDT 40785
2008-11-13 Other Important Information from FDA
INJECTABLE; INJECTION 50MG/ML Prescription AP  PROMETHAZINE HYDROCHLORIDE Promethazine WOCKHARDT   "
INJECTABLE; INJECTION 50MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 80629
INJECTABLE; INJECTION 25MG/ML Prescription AP  PROMETHAZINE HYDROCHLORIDE Promethazine BAXTER HLTHCARE 83312
INJECTABLE; INJECTION 50MG/ML Prescription AP  PROMETHAZINE HYDROCHLORIDE Promethazine BAXTER HLTHCARE   "
INJECTABLE; INJECTION 25MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 83532
INJECTABLE; INJECTION 50MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS   "
INJECTABLE; INJECTION 50MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine HOSPIRA 83838
INJECTABLE; INJECTION 25MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine AKORN 83955
INJECTABLE; INJECTION 50MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine AKORN   "
INJECTABLE; INJECTION 50MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABBOTT 84222
INJECTABLE; INJECTION 25MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABBOTT 84223
INJECTABLE; INJECTION 25MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 84591
INJECTABLE; INJECTION 25MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine MARSAM PHARMS LLC 89463
INJECTABLE; INJECTION 50MG/ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine MARSAM PHARMS LLC 89477
SUPPOSITORY; RECTAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine G AND W LABS 40428
2004-12-08 Review
SUPPOSITORY; RECTAL 25MG Prescription AB (Reference Drug) PROMETHAZINE HYDROCHLORIDE Promethazine G AND W LABS   "
SUPPOSITORY; RECTAL 50MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABLE 40449
SUPPOSITORY; RECTAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine PADDOCK LLC 40479
SUPPOSITORY; RECTAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine PADDOCK LLC   "
SUPPOSITORY; RECTAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine PERRIGO NEW YORK 40500
SUPPOSITORY; RECTAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine PERRIGO NEW YORK   "
SUPPOSITORY; RECTAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABLE 40504
SUPPOSITORY; RECTAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABLE   "
SUPPOSITORY; RECTAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine TARO 40603
2006-11-02 Other Important Information from FDA
SUPPOSITORY; RECTAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine TARO   "
SYRUP; ORAL 6.25MG/5ML Prescription AA  PROMETHAZINE HYDROCHLORIDE Promethazine HI TECH PHARMA 40026
1998-09-25 Letter
SYRUP; ORAL 6.25MG/5ML Prescription AA  PROMETHAZINE HYDROCHLORIDE Promethazine VINTAGE 40643
2006-05-03 Other Important Information from FDA
SYRUP; ORAL 6.25MG/5ML Prescription AA  PROMETHAZINE HYDROCHLORIDE Promethazine TARO 40718
2007-04-10 Other Important Information from FDA
SYRUP; ORAL 6.25MG/5ML Prescription AA  PROMETHAZINE HYDROCHLORIDE Promethazine AMNEAL PHARMS 40882
SYRUP; ORAL 6.25MG/5ML Prescription AA  PROMETHAZINE HYDROCHLORIDE Promethazine SUN PHARM INDS INC 40891
SYRUP; ORAL 25MG/5ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine KV PHARM 85385
SYRUP; ORAL 6.25MG/5ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine KV PHARM 85388
SYRUP; ORAL 6.25MG/5ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WHITEWORTH TOWN PLSN 86395
SYRUP; ORAL 6.25MG/5ML Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine PHARM ASSOC 87518
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABLE 40558
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABLE   "
TABLET; ORAL 50MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABLE   "
TABLET; ORAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine ZYDUS PHARMS USA 40596
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine ZYDUS PHARMS USA   "
TABLET; ORAL 50MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine ZYDUS PHARMS USA   "
TABLET; ORAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine VINTAGE PHARMS 40622
2006-07-31 Other Important Information from FDA
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine VINTAGE PHARMS   "
TABLET; ORAL 50MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine VINTAGE PHARMS   "
TABLET; ORAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine EMCURE PHARMS USA 40673
2008-03-10 Other Important Information from FDA
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine EMCURE PHARMS USA   "
TABLET; ORAL 50MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine EMCURE PHARMS USA   "
TABLET; ORAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine KVK TECH 40712
2006-08-11 Letter
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine KVK TECH   "
TABLET; ORAL 50MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine KVK TECH 40713
2006-08-11 Letter
TABLET; ORAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine IMPAX LABS 40724
2008-02-28 Other Important Information from FDA
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine IMPAX LABS   "
TABLET; ORAL 50MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine IMPAX LABS 40791
2008-05-30 Other Important Information from FDA
TABLET; ORAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine SUN PHARM INDS INC 40863
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine SUN PHARM INDS INC   "
TABLET; ORAL 50MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine SUN PHARM INDS INC   "
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine LANNETT 80949
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine LANNETT   "
TABLET; ORAL 50MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine LANNETT   "
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 83204
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine PVT FORM 83214
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 83401
TABLET; ORAL 50MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 83403
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 83426
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine IVAX SUB TEVA PHARMS 83603
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine IVAX SUB TEVA PHARMS 83604
TABLET; ORAL 50MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine IVAX SUB TEVA PHARMS 83613
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine PVT FORM 83658
TABLET; ORAL 50MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 83711
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 83712
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine TABLICAPS 84027
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine TABLICAPS 84080
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABBOTT 84160
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABBOTT 84166
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine SANDOZ 84176
TABLET; ORAL 50MG Prescription AB (Reference Drug) PROMETHAZINE HYDROCHLORIDE Promethazine SANDOZ   "
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine IMPAX LABS 84214
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine SANDOZ 84233
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine SANDOZ 84234
TABLET; ORAL 50MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine ABBOTT 84539
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine MUTUAL PHARM 84554
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine MUTUAL PHARM 84555
TABLET; ORAL 50MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine MUTUAL PHARM 84557
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine SANDOZ 85146
TABLET; ORAL 50MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine SANDOZ   "
TABLET; ORAL 50MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 85664
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 85684
TABLET; ORAL 12.5MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine WATSON LABS 85986
TABLET; ORAL 25MG Discontinued   PROMETHAZINE HYDROCHLORIDE Promethazine TEVA 89109
TABLET; ORAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine MYLAN 91054
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine MYLAN   "
TABLET; ORAL 50MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine MYLAN   "
TABLET; ORAL 12.5MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine AMNEAL PHARMS NY 91179
TABLET; ORAL 25MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine AMNEAL PHARMS NY   "
TABLET; ORAL 50MG Prescription AB  PROMETHAZINE HYDROCHLORIDE Promethazine AMNEAL PHARMS NY   "

Drug Adverse Effects information for PROMETHAZINE HYDROCHLORIDE

Role code Indications Reaction # Reports
SS ANXIETY ACTIVITIES OF DAILY LIVING IMPAIRED 2
SS ANXIETY MALAISE 2
SS DEPRESSION INTRAOCULAR PRESSURE INCREASED 2
SS HEADACHE ACTIVITIES OF DAILY LIVING IMPAIRED 2
SS HEADACHE MALAISE 2
SS HYPERTENSION ACTIVITIES OF DAILY LIVING IMPAIRED 1
SS HYPERTENSION MALAISE 1
SS MALAISE ACTIVITIES OF DAILY LIVING IMPAIRED 1
SS MALAISE MALAISE 1
SS PRODUCT USED FOR UNKNOWN INDICATION DEATH 3
SS SLEEP DISORDER ACTIVITIES OF DAILY LIVING IMPAIRED 1
SS SLEEP DISORDER INTRAOCULAR PRESSURE INCREASED 1
SS SLEEP DISORDER MALAISE 1
SS VOMITING ANKYLOGLOSSIA CONGENITAL 1
SS VOMITING CAESAREAN SECTION 1
SS VOMITING MATERNAL DRUGS AFFECTING FOETUS 1
C BREAST CANCER PANCREATITIS 2
C CONTRACEPTION ABDOMINAL PAIN 1
C CONTRACEPTION ABDOMINAL PAIN UPPER 1
C CONTRACEPTION ANXIETY 1
C CONTRACEPTION CHEST PAIN 1
C CONTRACEPTION CHOLECYSTITIS 2
C CONTRACEPTION CHOLELITHIASIS 1
C CONTRACEPTION DIARRHOEA 1
C CONTRACEPTION EMOTIONAL DISTRESS 1
C CONTRACEPTION GALLBLADDER CHOLESTEROLOSIS 1
C CONTRACEPTION GALLBLADDER DISORDER 2
C CONTRACEPTION HYPERTENSION 1
C CONTRACEPTION NAUSEA 2
C CONTRACEPTION VOMITING 1
C CONVULSION AMAUROSIS FUGAX 2
C CONVULSION ANXIETY 2
C CONVULSION AORTIC STENOSIS 2
C CONVULSION ASTHENIA 2
C CONVULSION BRONCHITIS BACTERIAL 2
C CONVULSION COLONIC STENOSIS 2
C CONVULSION CONVULSION 2
C CONVULSION COUGH 2
C CONVULSION DEHYDRATION 2
C CONVULSION DEPRESSION 2
C CONVULSION DRUG EFFECT DECREASED 2
C CONVULSION FIBROMYALGIA 2
C CONVULSION GALLBLADDER DISORDER 2
C CONVULSION GASTROOESOPHAGEAL REFLUX DISEASE 2
C CONVULSION INHIBITORY DRUG INTERACTION 2
C CONVULSION MIGRAINE 2
C CONVULSION NAUSEA 2
C CONVULSION OSTEOPENIA 2
C CONVULSION PALPITATIONS 2
C CONVULSION RESTLESS LEGS SYNDROME 2
C CONVULSION SUICIDAL IDEATION 2
C CONVULSION VOMITING 2
C CONVULSION VULVOVAGINAL CANDIDIASIS 2
C HYPOTHYROIDISM PANCREATITIS 1
C MULTIPLE ALLERGIES ABDOMINAL PAIN UPPER 1
C MULTIPLE ALLERGIES CHEST PAIN 1
C MULTIPLE ALLERGIES CHOLECYSTITIS 1
C MULTIPLE ALLERGIES CHOLELITHIASIS 1
C MULTIPLE ALLERGIES DIARRHOEA 1
C MULTIPLE ALLERGIES GALLBLADDER CHOLESTEROLOSIS 1
C MULTIPLE ALLERGIES GALLBLADDER DISORDER 1
C MULTIPLE ALLERGIES HYPERTENSION 1
C MULTIPLE ALLERGIES NAUSEA 1
C NAUSEA PANCREATITIS 1
C PAIN ABDOMINAL PAIN UPPER 1
C PAIN CHEST PAIN 1
C PAIN CHOLECYSTITIS 1
C PAIN CHOLELITHIASIS 1
C PAIN DIARRHOEA 1
C PAIN GALLBLADDER CHOLESTEROLOSIS 1
C PAIN GALLBLADDER DISORDER 1
C PAIN HYPERTENSION 1
C PAIN NAUSEA 1
C PAIN PANCREATITIS 1
C SICKLE CELL ANAEMIA ASTHENIA 1
C SICKLE CELL ANAEMIA BACK PAIN 1
C SICKLE CELL ANAEMIA BLOOD BILIRUBIN INCREASED 1
C SICKLE CELL ANAEMIA CHEST PAIN 1
C SICKLE CELL ANAEMIA DECREASED APPETITE 1
C SICKLE CELL ANAEMIA DYSPNOEA EXERTIONAL 1
C SICKLE CELL ANAEMIA GENERALISED OEDEMA 1
C SICKLE CELL ANAEMIA HEADACHE 1
C SICKLE CELL ANAEMIA HYPOXIA 1
C SICKLE CELL ANAEMIA PAIN IN EXTREMITY 1
C SICKLE CELL ANAEMIA SICKLE CELL ANAEMIA WITH CRISIS 1
C SMOKING CESSATION THERAPY AMAUROSIS FUGAX 1
C SMOKING CESSATION THERAPY ANXIETY 1
C SMOKING CESSATION THERAPY AORTIC STENOSIS 1
C SMOKING CESSATION THERAPY ASTHENIA 1
C SMOKING CESSATION THERAPY BRONCHITIS BACTERIAL 1
C SMOKING CESSATION THERAPY COLONIC STENOSIS 1
C SMOKING CESSATION THERAPY CONVULSION 1
C SMOKING CESSATION THERAPY COUGH 1
C SMOKING CESSATION THERAPY DEHYDRATION 1
C SMOKING CESSATION THERAPY DEPRESSION 1
C SMOKING CESSATION THERAPY DRUG EFFECT DECREASED 1
C SMOKING CESSATION THERAPY FIBROMYALGIA 1
C SMOKING CESSATION THERAPY GALLBLADDER DISORDER 1
C SMOKING CESSATION THERAPY GASTROOESOPHAGEAL REFLUX DISEASE 1
C SMOKING CESSATION THERAPY INHIBITORY DRUG INTERACTION 1
C SMOKING CESSATION THERAPY MIGRAINE 1
C SMOKING CESSATION THERAPY NAUSEA 1
C SMOKING CESSATION THERAPY OSTEOPENIA 1
C SMOKING CESSATION THERAPY PALPITATIONS 1
C SMOKING CESSATION THERAPY RESTLESS LEGS SYNDROME 1
C SMOKING CESSATION THERAPY SUICIDAL IDEATION 1
C SMOKING CESSATION THERAPY VOMITING 1
C SMOKING CESSATION THERAPY VULVOVAGINAL CANDIDIASIS 1
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