Drug information for DEXEDRINE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE, EXTENDED RELEASE; ORAL 10MG Prescription AB  DEXTROAMPHETAMINE SULFATE Dextroamphetamine COREPHARMA 17078
2009-11-18 Medication Guide
2008-06-12 Label
2008-05-28 Letter
2007-05-18 Other Important Information from FDA
2007-05-07 Letter
2007-05-07 Label
2006-08-14 Letter
2006-08-11 Label
CAPSULE, EXTENDED RELEASE; ORAL 15MG Prescription AB (Reference Drug) DEXTROAMPHETAMINE SULFATE Dextroamphetamine COREPHARMA   "
CAPSULE, EXTENDED RELEASE; ORAL 5MG Prescription AB  DEXTROAMPHETAMINE SULFATE Dextroamphetamine COREPHARMA   "
ELIXIR; ORAL 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Discontinued   DEXTROAMPHETAMINE SULFATE Dextroamphetamine GLAXOSMITHKLINE 83902
2007-05-18 Other Important Information from FDA
TABLET; ORAL 5MG Discontinued   DEXTROAMPHETAMINE SULFATE Dextroamphetamine GLAXOSMITHKLINE 84935
2007-05-18 Other Important Information from FDA

Drug Adverse Effects information for DEXEDRINE

Role code Indications Reaction # Reports
SS HYPERTENSION AORTIC VALVE INCOMPETENCE 2
SS HYPERTENSION CARDIAC VALVE DISEASE 2
SS HYPERTENSION DYSPNOEA EXERTIONAL 2
SS HYPERTENSION HYPERTENSION 2
SS NARCOLEPSY AORTIC VALVE INCOMPETENCE 10
SS NARCOLEPSY CARDIAC VALVE DISEASE 10
SS NARCOLEPSY DYSPNOEA EXERTIONAL 10
SS NARCOLEPSY HYPERTENSION 10
C ACNE ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C ACNE COLITIS ULCERATIVE 1
C ACNE CROHN'S DISEASE 1
C ACNE DEPRESSION 2
C ACNE GASTROINTESTINAL HYPOMOTILITY 1
C ACNE INFLAMMATORY BOWEL DISEASE 1
C ACNE INTESTINAL HAEMORRHAGE 1
C ACNE INTESTINAL OBSTRUCTION 2
C ACNE IRRITABLE BOWEL SYNDROME 1
C ACNE NEPHROLITHIASIS 1
C ACNE OSTEOPOROSIS 1
C ATTENTION DEFICIT/HYPERACTIVITY DISORDER BLOOD THYROID STIMULATING HORMONE DECREASED 1
C BACK PAIN SUNBURN 3
C BIPOLAR DISORDER BLOOD THYROID STIMULATING HORMONE DECREASED 1
C DEPRESSION AORTIC VALVE INCOMPETENCE 2
C DEPRESSION COLITIS ULCERATIVE 1
C DEPRESSION CROHN'S DISEASE 1
C DEPRESSION DEPRESSION 1
C DEPRESSION INFLAMMATORY BOWEL DISEASE 1
C DEPRESSION INTESTINAL HAEMORRHAGE 1
C DEPRESSION INTESTINAL OBSTRUCTION 1
C DEPRESSION IRRITABLE BOWEL SYNDROME 1
C DEPRESSION NEPHROLITHIASIS 1
C DEPRESSION OFF LABEL USE 2
C DEPRESSION OSTEOPOROSIS 1
C DEPRESSION SUNBURN 1
C FATIGUE SUNBURN 1
C MULTIPLE SCLEROSIS CATARACT 1
C MULTIPLE SCLEROSIS DIABETES MELLITUS 1
C MULTIPLE SCLEROSIS IMMUNE RECONSTITUTION SYNDROME 1
C MULTIPLE SCLEROSIS ORAL HERPES 1
C MULTIPLE SCLEROSIS PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY 1
C MULTIPLE SCLEROSIS SUNBURN 1
C MULTIPLE SCLEROSIS ULCER 1
C NARCOLEPSY AORTIC VALVE INCOMPETENCE 10
C NARCOLEPSY OFF LABEL USE 10
C ORAL CONTRACEPTION COLITIS ULCERATIVE 1
C ORAL CONTRACEPTION CROHN'S DISEASE 1
C ORAL CONTRACEPTION DEPRESSION 1
C ORAL CONTRACEPTION INFLAMMATORY BOWEL DISEASE 1
C ORAL CONTRACEPTION INTESTINAL HAEMORRHAGE 1
C ORAL CONTRACEPTION INTESTINAL OBSTRUCTION 1
C ORAL CONTRACEPTION IRRITABLE BOWEL SYNDROME 1
C ORAL CONTRACEPTION NEPHROLITHIASIS 1
C ORAL CONTRACEPTION OSTEOPOROSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION AORTIC VALVE INCOMPETENCE 4
C PRODUCT USED FOR UNKNOWN INDICATION OFF LABEL USE 4
C SYSTEMIC LUPUS ERYTHEMATOSUS AORTIC VALVE INCOMPETENCE 4
C SYSTEMIC LUPUS ERYTHEMATOSUS OFF LABEL USE 4
C TYPE 2 DIABETES MELLITUS AORTIC VALVE INCOMPETENCE 2
C TYPE 2 DIABETES MELLITUS OFF LABEL USE 2
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