Drug information for ORTHO EVRA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
FILM, EXTENDED RELEASE; TRANSDERMAL 0.02MG/24HR;0.15MG/24HR Prescription  (Reference Drug) ETHINYL ESTRADIOL; NORELGESTROMIN Ortho Evra JANSSEN PHARMS 21180
2012-01-03 Letter

2011-12-28 Label

2011-08-12 Label

2011-07-28 Letter

2011-03-28 Label

2011-03-25 Letter

2010-04-19 Label

2010-04-19 Letter

2010-01-25 Letter

2009-12-02 Label

2009-11-10 Letter

2009-11-10 Letter

2009-09-17 Label

2009-08-13 Label

2008-11-07 Label

2008-11-07 Label

2008-11-07 Label

2008-11-03 Letter

2008-11-03 Letter

2008-11-03 Letter

2008-08-01 Review

2008-08-01 Review

2008-07-31 Review

2008-01-18 Label

2007-06-29 Review

2006-09-22 Other Important Information from FDA

2006-09-20 Letter

2006-09-20 Label

2006-07-11 Review

2006-07-11 Review

2006-05-21 Letter

2005-11-18 Letter

2005-11-10 Label

2005-05-17 Label

2005-05-17 Letter

2004-12-02 Letter

2004-03-02 Letter

2001-11-20 Review

2001-11-20 Label

2001-11-20 Letter

Drug Adverse Effects information for ORTHO EVRA

Role code Indications Reaction # Reports
PS ANTIINFLAMMATORY THERAPY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS ANTIINFLAMMATORY THERAPY MENSTRUATION IRREGULAR 1
PS ANTIINFLAMMATORY THERAPY TENDONITIS 1
PS ASTHMA ASTHMA 5
PS ASTHMA CONTUSION 3
PS ASTHMA DRUG DOSE OMISSION 2
PS ASTHMA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 5
PS ASTHMA INCORRECT DOSE ADMINISTERED 2
PS ASTHMA INTERVERTEBRAL DISC DISPLACEMENT 3
PS ASTHMA MENSTRUATION DELAYED 2
PS ASTHMA PRESBYOPIA 3
PS ASTHMA PRODUCT ADHESION ISSUE 3
PS ASTHMA ROAD TRAFFIC ACCIDENT 3
PS ASTHMA WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
PS CONTRACEPTION ABORTION 2
PS CONTRACEPTION ACNE 1
PS CONTRACEPTION ADNEXA UTERI PAIN 2
PS CONTRACEPTION ANAEMIA 3
PS CONTRACEPTION ANGER 1
PS CONTRACEPTION ARTHRITIS 1
PS CONTRACEPTION ARTHROPATHY 1
PS CONTRACEPTION ASTHMA 3
PS CONTRACEPTION CARDIAC VALVE DISEASE 1
PS CONTRACEPTION CONTUSION 1
PS CONTRACEPTION CONVULSION 1
PS CONTRACEPTION DEHYDRATION 1
PS CONTRACEPTION DEPRESSION 1
PS CONTRACEPTION DRUG DOSE OMISSION 3
PS CONTRACEPTION DRUG PRESCRIBING ERROR 1
PS CONTRACEPTION EPILEPSY 1
PS CONTRACEPTION EYELID OEDEMA 1
PS CONTRACEPTION FOOT FRACTURE 1
PS CONTRACEPTION GASTROENTERITIS VIRAL 1
PS CONTRACEPTION HAIR GROWTH ABNORMAL 1
PS CONTRACEPTION HYPERCOAGULATION 2
PS CONTRACEPTION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 8
PS CONTRACEPTION INCORRECT DOSE ADMINISTERED 2
PS CONTRACEPTION INSOMNIA 1
PS CONTRACEPTION INTERVERTEBRAL DISC DISPLACEMENT 1
PS CONTRACEPTION INTRACARDIAC THROMBUS 2
PS CONTRACEPTION JOINT DISLOCATION 1
PS CONTRACEPTION MALAISE 2
PS CONTRACEPTION MATERNAL EXPOSURE DURING PREGNANCY 2
PS CONTRACEPTION MENSTRUATION DELAYED 2
PS CONTRACEPTION MENSTRUATION IRREGULAR 1
PS CONTRACEPTION METRORRHAGIA 2
PS CONTRACEPTION MIGRAINE 1
PS CONTRACEPTION OEDEMA PERIPHERAL 1
PS CONTRACEPTION OFF LABEL USE 5
PS CONTRACEPTION OVARIAN CYST 1
PS CONTRACEPTION PALLOR 1
PS CONTRACEPTION POLYMENORRHOEA 1
PS CONTRACEPTION PREGNANCY WITH CONTRACEPTIVE PATCH 2
PS CONTRACEPTION PRESBYOPIA 1
PS CONTRACEPTION PRODUCT ADHESION ISSUE 1
PS CONTRACEPTION PRODUCT QUALITY ISSUE 1
PS CONTRACEPTION PULMONARY EMBOLISM 4
PS CONTRACEPTION RIGHT VENTRICULAR FAILURE 2
PS CONTRACEPTION ROAD TRAFFIC ACCIDENT 1
PS CONTRACEPTION SEXUALLY TRANSMITTED DISEASE 1
PS CONTRACEPTION SUICIDAL IDEATION 1
PS CONTRACEPTION TENDONITIS 1
PS CONTRACEPTION THROMBOSIS 2
PS CONTRACEPTION TOXICITY TO VARIOUS AGENTS 1
PS CONTRACEPTION TREATMENT NONCOMPLIANCE 3
PS CONTRACEPTION VAGINAL HAEMORRHAGE 3
PS CONTRACEPTION VARICOSE VEIN 1
PS CONTRACEPTION WEIGHT INCREASED 1
PS CONTRACEPTION WITHDRAWAL BLEED 3
PS CONTRACEPTION WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
PS DYSMENORRHOEA CARDIAC VALVE DISEASE 1
PS DYSMENORRHOEA MIGRAINE 1
PS DYSMENORRHOEA OFF LABEL USE 2
PS DYSMENORRHOEA PULMONARY EMBOLISM 2
PS DYSMENORRHOEA RIGHT VENTRICULAR FAILURE 2
PS FATIGUE ANGER 1
PS FATIGUE EPILEPSY 1
PS FATIGUE EYELID OEDEMA 1
PS FATIGUE INSOMNIA 1
PS FATIGUE MALAISE 1
PS FATIGUE OEDEMA PERIPHERAL 1
PS FATIGUE TREATMENT NONCOMPLIANCE 1
PS GASTROINTESTINAL DISORDER THERAPY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS GASTROINTESTINAL DISORDER THERAPY MENSTRUATION IRREGULAR 1
PS GASTROINTESTINAL DISORDER THERAPY TENDONITIS 1
PS HAEMORRHAGE ARTHRITIS 1
PS HAEMORRHAGE ARTHROPATHY 1
PS HAEMORRHAGE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS HAEMORRHAGE JOINT DISLOCATION 1
PS HAEMORRHAGE OFF LABEL USE 2
PS HAEMORRHAGE PRODUCT QUALITY ISSUE 1
PS HORMONE THERAPY CARDIAC VALVE DISEASE 1
PS HORMONE THERAPY MIGRAINE 1
PS HORMONE THERAPY OFF LABEL USE 1
PS HORMONE THERAPY PULMONARY EMBOLISM 1
PS HORMONE THERAPY RIGHT VENTRICULAR FAILURE 1
PS ILL-DEFINED DISORDER ADNEXA UTERI PAIN 2
PS ILL-DEFINED DISORDER POLYMENORRHOEA 1
PS ILL-DEFINED DISORDER TREATMENT NONCOMPLIANCE 2
PS ILL-DEFINED DISORDER WITHDRAWAL BLEED 1
PS MENSTRUATION IRREGULAR CHEST PAIN 1
PS MENSTRUATION IRREGULAR DYSPNOEA 1
PS MENSTRUATION IRREGULAR MUSCULOSKELETAL PAIN 1
PS MENSTRUATION IRREGULAR OFF LABEL USE 1
PS MENSTRUATION IRREGULAR OVARIAN CYST 1
PS MENSTRUATION IRREGULAR PAIN IN EXTREMITY 1
PS MOOD SWINGS CARDIAC VALVE DISEASE 1
PS MOOD SWINGS MIGRAINE 1
PS MOOD SWINGS OFF LABEL USE 2
PS MOOD SWINGS PULMONARY EMBOLISM 2
PS MOOD SWINGS RIGHT VENTRICULAR FAILURE 2
PS MUSCLE SPASMS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS MUSCLE SPASMS MENSTRUATION IRREGULAR 1
PS MUSCLE SPASMS TENDONITIS 1
PS PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS PAIN MENSTRUATION IRREGULAR 1
PS PAIN TENDONITIS 1
PS POLYCYSTIC OVARIES OFF LABEL USE 1
PS POLYCYSTIC OVARIES VISUAL IMPAIRMENT 1
PS PRODUCT USED FOR UNKNOWN INDICATION ACNE 1
PS PRODUCT USED FOR UNKNOWN INDICATION BURNING SENSATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION CYSTITIS 2
PS PRODUCT USED FOR UNKNOWN INDICATION DEATH 1
PS PRODUCT USED FOR UNKNOWN INDICATION DEPRESSION 1
PS PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 1
PS PRODUCT USED FOR UNKNOWN INDICATION HOT FLUSH 1
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERCOAGULATION 3
PS PRODUCT USED FOR UNKNOWN INDICATION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION INFECTION 1
PS PRODUCT USED FOR UNKNOWN INDICATION INTRACARDIAC THROMBUS 3
PS PRODUCT USED FOR UNKNOWN INDICATION KIDNEY ENLARGEMENT 1
PS PRODUCT USED FOR UNKNOWN INDICATION METRORRHAGIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION MOOD SWINGS 1
PS PRODUCT USED FOR UNKNOWN INDICATION MUSCULOSKELETAL CHEST PAIN 1
PS PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION NEPHROLITHIASIS 1
PS PRODUCT USED FOR UNKNOWN INDICATION NEPHROTIC SYNDROME 1
PS PRODUCT USED FOR UNKNOWN INDICATION PARAESTHESIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION PRURITUS 1
PS PRODUCT USED FOR UNKNOWN INDICATION PULMONARY EMBOLISM 3
PS PRODUCT USED FOR UNKNOWN INDICATION SYNCOPE 1
PS PRODUCT USED FOR UNKNOWN INDICATION THROMBOSIS 3
PS PRODUCT USED FOR UNKNOWN INDICATION TREATMENT NONCOMPLIANCE 1
PS PRODUCT USED FOR UNKNOWN INDICATION VAGINAL HAEMORRHAGE 1
PS PRODUCT USED FOR UNKNOWN INDICATION WITHDRAWAL BLEED 1
PS PRODUCT USED FOR UNKNOWN INDICATION WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
SS ASTHMA ASTHMA 3
SS ASTHMA CONTUSION 3
SS ASTHMA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 3
SS ASTHMA INTERVERTEBRAL DISC DISPLACEMENT 3
SS ASTHMA PRESBYOPIA 3
SS ASTHMA PRODUCT ADHESION ISSUE 3
SS ASTHMA ROAD TRAFFIC ACCIDENT 3
SS ASTHMA WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
SS CONTRACEPTION ARTHRITIS 1
SS CONTRACEPTION ARTHROPATHY 1
SS CONTRACEPTION ASTHMA 1
SS CONTRACEPTION CARDIAC VALVE DISEASE 3
SS CONTRACEPTION CONTUSION 1
SS CONTRACEPTION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 2
SS CONTRACEPTION INTERVERTEBRAL DISC DISPLACEMENT 1
SS CONTRACEPTION JOINT DISLOCATION 1
SS CONTRACEPTION MIGRAINE 3
SS CONTRACEPTION OFF LABEL USE 8
SS CONTRACEPTION OVARIAN CYST 1
SS CONTRACEPTION PRESBYOPIA 1
SS CONTRACEPTION PRODUCT ADHESION ISSUE 1
SS CONTRACEPTION PRODUCT QUALITY ISSUE 1
SS CONTRACEPTION PULMONARY EMBOLISM 5
SS CONTRACEPTION RIGHT VENTRICULAR FAILURE 5
SS CONTRACEPTION ROAD TRAFFIC ACCIDENT 1
SS CONTRACEPTION WRONG TECHNIQUE IN DRUG USAGE PROCESS 1
SS DYSMENORRHOEA CARDIAC VALVE DISEASE 3
SS DYSMENORRHOEA MIGRAINE 3
SS DYSMENORRHOEA OFF LABEL USE 5
SS DYSMENORRHOEA PULMONARY EMBOLISM 5
SS DYSMENORRHOEA RIGHT VENTRICULAR FAILURE 5
SS FOETAL EXPOSURE DURING PREGNANCY ANKYLOGLOSSIA CONGENITAL 2
SS FOETAL EXPOSURE DURING PREGNANCY FEEDING DISORDER NEONATAL 2
SS FOETAL EXPOSURE DURING PREGNANCY JAW DISORDER 2
SS FOETAL EXPOSURE DURING PREGNANCY LIP DISORDER 2
SS HAEMORRHAGE ARTHRITIS 1
SS HAEMORRHAGE ARTHROPATHY 1
SS HAEMORRHAGE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
SS HAEMORRHAGE JOINT DISLOCATION 1
SS HAEMORRHAGE OFF LABEL USE 2
SS HAEMORRHAGE PRODUCT QUALITY ISSUE 1
SS HORMONE THERAPY CARDIAC VALVE DISEASE 3
SS HORMONE THERAPY MIGRAINE 3
SS HORMONE THERAPY OFF LABEL USE 3
SS HORMONE THERAPY PULMONARY EMBOLISM 3
SS HORMONE THERAPY RIGHT VENTRICULAR FAILURE 3
SS MENSTRUATION IRREGULAR OFF LABEL USE 1
SS MENSTRUATION IRREGULAR OVARIAN CYST 1
SS MOOD SWINGS CARDIAC VALVE DISEASE 3
SS MOOD SWINGS MIGRAINE 3
SS MOOD SWINGS OFF LABEL USE 5
SS MOOD SWINGS PULMONARY EMBOLISM 5
SS MOOD SWINGS RIGHT VENTRICULAR FAILURE 5
C ACNE ABDOMINAL PAIN 1
C ACNE BILE DUCT STONE 1
C ACNE CHOLECYSTITIS ACUTE 1
C ACNE CHOLECYSTITIS CHRONIC 1
C ACNE COLITIS ULCERATIVE 1
C ACNE DEPRESSION 1
C ACNE EMOTIONAL DISTRESS 1
C ACNE INFLAMMATORY BOWEL DISEASE 1
C ACNE IRRITABLE BOWEL SYNDROME 1
C ACNE NAUSEA 1
C ACNE PAIN 1
C ACNE PANIC ATTACK 1
C ACNE VOMITING 1
C BACK PAIN BILIARY DYSKINESIA 2
C BACK PAIN CHOLECYSTECTOMY 2
C BACK PAIN CHOLECYSTITIS CHRONIC 1
C BACK PAIN GALLBLADDER DISORDER 1
C CONTRACEPTION ABDOMINAL PAIN 3
C CONTRACEPTION ANXIETY 2
C CONTRACEPTION BILE DUCT STONE 1
C CONTRACEPTION CHOLECYSTITIS ACUTE 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 5
C CONTRACEPTION CHOLELITHIASIS 4
C CONTRACEPTION EMOTIONAL DISTRESS 2
C CONTRACEPTION INJURY 4
C CONTRACEPTION IRRITABILITY 2
C CONTRACEPTION MALAISE 2
C CONTRACEPTION MENSTRUATION IRREGULAR 1
C CONTRACEPTION MIGRAINE 2
C CONTRACEPTION NAUSEA 3
C CONTRACEPTION PAIN 5
C CONTRACEPTION VOMITING 1
C MIGRAINE ABDOMINAL PAIN 1
C MIGRAINE BILE DUCT STONE 1
C MIGRAINE CHOLECYSTITIS ACUTE 1
C MIGRAINE CHOLECYSTITIS CHRONIC 1
C MIGRAINE NAUSEA 1
C MIGRAINE PAIN 1
C MIGRAINE VOMITING 1
C ORAL CONTRACEPTION ABDOMINAL PAIN 1
C ORAL CONTRACEPTION BILE DUCT STONE 1
C ORAL CONTRACEPTION BILIARY DYSKINESIA 2
C ORAL CONTRACEPTION CHOLECYSTECTOMY 2
C ORAL CONTRACEPTION CHOLECYSTITIS ACUTE 1
C ORAL CONTRACEPTION CHOLECYSTITIS CHRONIC 2
C ORAL CONTRACEPTION GALLBLADDER DISORDER 1
C ORAL CONTRACEPTION NAUSEA 1
C ORAL CONTRACEPTION PAIN 1
C ORAL CONTRACEPTION VOMITING 1
C POST COITAL CONTRACEPTION MENSTRUATION IRREGULAR 1
C PREMENSTRUAL SYNDROME BILIARY DYSKINESIA 2
C PREMENSTRUAL SYNDROME CHOLECYSTECTOMY 2
C PREMENSTRUAL SYNDROME CHOLECYSTITIS CHRONIC 1
C PREMENSTRUAL SYNDROME GALLBLADDER DISORDER 1
C SMOKING CESSATION THERAPY IRRITABILITY 2
C SMOKING CESSATION THERAPY MALAISE 2
C SMOKING CESSATION THERAPY MIGRAINE 2
C SMOKING CESSATION THERAPY NAUSEA 2
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