Drug information for SARAFEM

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL EQ 10MG BASE Prescription AB2  FLUOXETINE HYDROCHLORIDE Fluoxetine LILLY 18936
2011-06-16 Label

2011-06-16 Letter

2011-06-15 Medication Guide

2011-06-15 Medication Guide

2011-06-15 Medication Guide

2011-04-13 Letter

2011-04-13 Letter

2011-04-13 Letter

2011-04-04 Label

2011-04-04 Label

2011-04-04 Label

2009-11-20 Medication Guide

2009-06-24 Label

2009-06-24 Letter

2009-03-24 Letter

2009-03-24 Letter

2009-03-20 Label

2009-03-20 Label

2009-02-04 Label

2009-02-03 Letter

2008-07-01 Letter

2008-06-30 Label

2008-03-24 Letter

2008-03-24 Label

2008-03-13 Label

2008-03-12 Letter

2007-12-06 Review

2007-08-07 Letter

2007-08-07 Letter

2007-08-03 Label

2007-08-03 Label

2007-03-23 Letter

2007-02-20 Review

2007-02-20 Review

2007-02-20 Review

2006-09-21 Label

2006-04-13 Letter

2005-12-05 Letter

2005-12-05 Letter

2005-08-01 Other Important Information from FDA

2005-02-23 Letter

2004-09-03 Letter

2004-08-25 Letter

2004-08-09 Review

2004-08-09 Review

2003-09-25 Review

2003-09-25 Review

2003-01-07 Label

2003-01-07 Letter

2002-07-29 Label

2002-06-12 Label

2002-06-12 Letter

2000-07-06 Letter

2000-07-06 Label
CAPSULE; ORAL EQ 20MG BASE Prescription AB2 (Reference Drug) FLUOXETINE HYDROCHLORIDE Fluoxetine LILLY   "
TABLET; ORAL EQ 10MG BASE Prescription   FLUOXETINE HYDROCHLORIDE Fluoxetine WARNER CHILCOTT 21860
2010-12-03 Medication Guide

2009-04-28 Label

2009-04-27 Letter

2008-09-05 Review

2007-12-03 Letter

2007-12-03 Label

2007-05-09 Other Important Information from FDA

2007-04-09 Letter

2007-04-09 Label

2006-05-22 Label

2006-05-22 Letter
TABLET; ORAL EQ 15MG BASE Prescription   FLUOXETINE HYDROCHLORIDE Fluoxetine WARNER CHILCOTT   "
TABLET; ORAL EQ 20MG BASE Prescription  (Reference Drug) FLUOXETINE HYDROCHLORIDE Fluoxetine WARNER CHILCOTT   "

Drug Adverse Effects information for SARAFEM

Role code Indications Reaction # Reports
C ANTICOAGULANT THERAPY ANHEDONIA 1
C ANTICOAGULANT THERAPY ARTHRALGIA 1
C ANTICOAGULANT THERAPY CHOLECYSTITIS CHRONIC 1
C ANTICOAGULANT THERAPY DEEP VEIN THROMBOSIS 1
C ANTICOAGULANT THERAPY EMOTIONAL DISTRESS 1
C ANTICOAGULANT THERAPY ERYTHEMA 1
C ANTICOAGULANT THERAPY HYPOAESTHESIA 1
C ANTICOAGULANT THERAPY LIMB DISCOMFORT 1
C ANTICOAGULANT THERAPY MUSCLE SPASMS 1
C ANTICOAGULANT THERAPY OEDEMA PERIPHERAL 1
C ANTICOAGULANT THERAPY POOR PERIPHERAL CIRCULATION 1
C ANTICOAGULANT THERAPY TENDERNESS 1
C ANTICOAGULANT THERAPY THROMBOPHLEBITIS SUPERFICIAL 1
C ASTHMA ANHEDONIA 1
C ASTHMA ARTHRALGIA 1
C ASTHMA CHOLECYSTITIS CHRONIC 1
C ASTHMA DEEP VEIN THROMBOSIS 1
C ASTHMA EMOTIONAL DISTRESS 1
C ASTHMA ERYTHEMA 1
C ASTHMA HYPOAESTHESIA 1
C ASTHMA LIMB DISCOMFORT 1
C ASTHMA MUSCLE SPASMS 1
C ASTHMA OEDEMA PERIPHERAL 1
C ASTHMA POOR PERIPHERAL CIRCULATION 1
C ASTHMA TENDERNESS 1
C ASTHMA THROMBOPHLEBITIS SUPERFICIAL 1
C CONTRACEPTION ADRENAL INSUFFICIENCY 1
C CONTRACEPTION BILIARY DYSKINESIA 1
C CONTRACEPTION CHOLECYSTITIS 2
C CONTRACEPTION CHOLECYSTITIS CHRONIC 1
C CONTRACEPTION DEPRESSION 1
C CONTRACEPTION FLUID RETENTION 1
C CONTRACEPTION GALLBLADDER DISORDER 3
C CONTRACEPTION HYPERTENSION 1
C CONTRACEPTION LYMPHOMA 1
C CONTRACEPTION NON-HODGKIN'S LYMPHOMA 1
C CONTRACEPTION PAIN 2
C CONTRACEPTION PALPITATIONS 1
C CONTRACEPTION STRESS 1
C DYSMENORRHOEA CALCULUS URETERIC 2
C DYSMENORRHOEA INJURY 2
C DYSMENORRHOEA NEPHROLITHIASIS 2
C DYSMENORRHOEA PAIN 2
C DYSPEPSIA CHOLECYSTITIS 2
C DYSPEPSIA DYSPNOEA 2
C DYSPEPSIA PAIN 2
C DYSPEPSIA VOMITING 2
C DYSPEPSIA VOMITING PSYCHOGENIC 2
C GASTROOESOPHAGEAL REFLUX DISEASE ANHEDONIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE ARTHRALGIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE CHOLECYSTITIS CHRONIC 1
C GASTROOESOPHAGEAL REFLUX DISEASE DEEP VEIN THROMBOSIS 1
C GASTROOESOPHAGEAL REFLUX DISEASE EMOTIONAL DISTRESS 1
C GASTROOESOPHAGEAL REFLUX DISEASE ERYTHEMA 1
C GASTROOESOPHAGEAL REFLUX DISEASE HYPOAESTHESIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE LIMB DISCOMFORT 1
C GASTROOESOPHAGEAL REFLUX DISEASE MUSCLE SPASMS 1
C GASTROOESOPHAGEAL REFLUX DISEASE OEDEMA PERIPHERAL 1
C GASTROOESOPHAGEAL REFLUX DISEASE POOR PERIPHERAL CIRCULATION 1
C GASTROOESOPHAGEAL REFLUX DISEASE TENDERNESS 1
C GASTROOESOPHAGEAL REFLUX DISEASE THROMBOPHLEBITIS SUPERFICIAL 1
C MENSTRUAL CYCLE MANAGEMENT ADRENAL INSUFFICIENCY 1
C MENSTRUAL CYCLE MANAGEMENT BILIARY DYSKINESIA 1
C MENSTRUAL CYCLE MANAGEMENT CHOLECYSTITIS 2
C MENSTRUAL CYCLE MANAGEMENT CHOLECYSTITIS CHRONIC 1
C MENSTRUAL CYCLE MANAGEMENT DEPRESSION 1
C MENSTRUAL CYCLE MANAGEMENT DYSPNOEA 2
C MENSTRUAL CYCLE MANAGEMENT FLUID RETENTION 1
C MENSTRUAL CYCLE MANAGEMENT GALLBLADDER DISORDER 1
C MENSTRUAL CYCLE MANAGEMENT HYPERTENSION 1
C MENSTRUAL CYCLE MANAGEMENT LYMPHOMA 1
C MENSTRUAL CYCLE MANAGEMENT NON-HODGKIN'S LYMPHOMA 1
C MENSTRUAL CYCLE MANAGEMENT PAIN 2
C MENSTRUAL CYCLE MANAGEMENT PALPITATIONS 1
C MENSTRUAL CYCLE MANAGEMENT STRESS 1
C MENSTRUAL CYCLE MANAGEMENT VOMITING 2
C MENSTRUAL CYCLE MANAGEMENT VOMITING PSYCHOGENIC 2
C MIGRAINE CHOLECYSTITIS 1
C MIGRAINE GALLBLADDER DISORDER 1
C MIGRAINE PAIN 1
C MULTIPLE ALLERGIES ANHEDONIA 1
C MULTIPLE ALLERGIES ARTHRALGIA 1
C MULTIPLE ALLERGIES CHOLECYSTITIS CHRONIC 1
C MULTIPLE ALLERGIES DEEP VEIN THROMBOSIS 1
C MULTIPLE ALLERGIES EMOTIONAL DISTRESS 1
C MULTIPLE ALLERGIES ERYTHEMA 1
C MULTIPLE ALLERGIES HYPOAESTHESIA 1
C MULTIPLE ALLERGIES LIMB DISCOMFORT 1
C MULTIPLE ALLERGIES MUSCLE SPASMS 1
C MULTIPLE ALLERGIES OEDEMA PERIPHERAL 1
C MULTIPLE ALLERGIES POOR PERIPHERAL CIRCULATION 1
C MULTIPLE ALLERGIES TENDERNESS 1
C MULTIPLE ALLERGIES THROMBOPHLEBITIS SUPERFICIAL 1
C PAIN MANAGEMENT ANHEDONIA 1
C PAIN MANAGEMENT ARTHRALGIA 1
C PAIN MANAGEMENT CHOLECYSTITIS CHRONIC 1
C PAIN MANAGEMENT DEEP VEIN THROMBOSIS 1
C PAIN MANAGEMENT EMOTIONAL DISTRESS 1
C PAIN MANAGEMENT ERYTHEMA 1
C PAIN MANAGEMENT HYPOAESTHESIA 1
C PAIN MANAGEMENT LIMB DISCOMFORT 1
C PAIN MANAGEMENT MUSCLE SPASMS 1
C PAIN MANAGEMENT OEDEMA PERIPHERAL 1
C PAIN MANAGEMENT POOR PERIPHERAL CIRCULATION 1
C PAIN MANAGEMENT TENDERNESS 1
C PAIN MANAGEMENT THROMBOPHLEBITIS SUPERFICIAL 1
C PREMENSTRUAL SYNDROME ANGER 2
C PREMENSTRUAL SYNDROME ANHEDONIA 2
C PREMENSTRUAL SYNDROME ANXIETY 2
C PREMENSTRUAL SYNDROME ARTHRALGIA 2
C PREMENSTRUAL SYNDROME CALCULUS URETERIC 2
C PREMENSTRUAL SYNDROME CHOLECYSTITIS 2
C PREMENSTRUAL SYNDROME CHOLECYSTITIS CHRONIC 2
C PREMENSTRUAL SYNDROME DEEP VEIN THROMBOSIS 4
C PREMENSTRUAL SYNDROME DEPRESSION 2
C PREMENSTRUAL SYNDROME DYSPNOEA 2
C PREMENSTRUAL SYNDROME EMOTIONAL DISTRESS 2
C PREMENSTRUAL SYNDROME ERYTHEMA 2
C PREMENSTRUAL SYNDROME GAIT DISTURBANCE 2
C PREMENSTRUAL SYNDROME HYPOAESTHESIA 2
C PREMENSTRUAL SYNDROME INJURY 2
C PREMENSTRUAL SYNDROME IRRITABILITY 2
C PREMENSTRUAL SYNDROME LIMB DISCOMFORT 2
C PREMENSTRUAL SYNDROME MUSCLE SPASMS 2
C PREMENSTRUAL SYNDROME NEPHROLITHIASIS 2
C PREMENSTRUAL SYNDROME OEDEMA PERIPHERAL 4
C PREMENSTRUAL SYNDROME PAIN 4
C PREMENSTRUAL SYNDROME PAIN IN EXTREMITY 2
C PREMENSTRUAL SYNDROME POOR PERIPHERAL CIRCULATION 2
C PREMENSTRUAL SYNDROME TENDERNESS 2
C PREMENSTRUAL SYNDROME THROMBOPHLEBITIS SUPERFICIAL 2
C PREMENSTRUAL SYNDROME VOMITING 2
C PREMENSTRUAL SYNDROME VOMITING PSYCHOGENIC 2
C SINUS HEADACHE CALCULUS URETERIC 1
C SINUS HEADACHE INJURY 1
C SINUS HEADACHE NEPHROLITHIASIS 1
C SINUS HEADACHE PAIN 1
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