Drug information for EMSAM

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
FILM, EXTENDED RELEASE; TRANSDERMAL 12MG/24HR Prescription   SELEGILINE Selegiline SOMERSET 21336
2008-02-14 Letter

2007-09-10 Review

2007-08-02 Letter

2007-07-31 Label

2007-05-09 Other Important Information from FDA

2007-02-20 Medication Guide

2006-03-03 Label

2006-03-03 Letter
FILM, EXTENDED RELEASE; TRANSDERMAL 6MG/24HR Prescription  (Reference Drug) SELEGILINE Selegiline SOMERSET   "
FILM, EXTENDED RELEASE; TRANSDERMAL 9MG/24HR Prescription   SELEGILINE Selegiline SOMERSET   "
SYSTEM; TRANSDERMAL 12MG Prescription   SELEGILINE Selegiline SOMERSET 21708
2007-09-10 Review

2007-05-09 Other Important Information from FDA

2007-02-20 Medication Guide

2006-03-03 Label

2006-03-03 Letter
SYSTEM; TRANSDERMAL 6MG Prescription   SELEGILINE Selegiline SOMERSET   "
SYSTEM; TRANSDERMAL 9MG Prescription   SELEGILINE Selegiline SOMERSET   "

Drug Adverse Effects information for EMSAM

Role code Indications Reaction # Reports
PS ANXIETY ANGIOEDEMA 1
PS ANXIETY APPLICATION SITE RASH 1
PS DEPRESSION ANGIOEDEMA 1
PS DEPRESSION APPLICATION SITE RASH 1
PS DEPRESSION DISSOCIATIVE FUGUE 2
PS DEPRESSION DISTURBANCE IN ATTENTION 2
PS DEPRESSION RESTLESSNESS 2
SS ANXIETY ANGIOEDEMA 1
SS ANXIETY APPLICATION SITE RASH 1
SS DEPRESSION ANGIOEDEMA 1
SS DEPRESSION APPLICATION SITE RASH 1
C BIPOLAR DISORDER HYPOMANIA 3
C DEPRESSION BURNING SENSATION 2
C DEPRESSION CYANOSIS 2
C DEPRESSION DENTAL CARIES 2
C DEPRESSION ERYTHEMA 2
C DEPRESSION HYPERHIDROSIS 2
C DEPRESSION HYPOAESTHESIA 2
C DEPRESSION OEDEMA PERIPHERAL 2
C DEPRESSION OVERDOSE 2
C DEPRESSION PARAESTHESIA 2
C DEPRESSION PERIPHERAL COLDNESS 2
C DEPRESSION PRURITUS 2
C DEPRESSION RASH MACULAR 2
C DEPRESSION TEMPERATURE INTOLERANCE 2
C PARKINSON'S DISEASE BURNING SENSATION 4
C PARKINSON'S DISEASE CYANOSIS 4
C PARKINSON'S DISEASE DENTAL CARIES 4
C PARKINSON'S DISEASE ERYTHEMA 4
C PARKINSON'S DISEASE HYPERHIDROSIS 4
C PARKINSON'S DISEASE HYPOAESTHESIA 4
C PARKINSON'S DISEASE OEDEMA PERIPHERAL 4
C PARKINSON'S DISEASE OVERDOSE 4
C PARKINSON'S DISEASE PARAESTHESIA 4
C PARKINSON'S DISEASE PERIPHERAL COLDNESS 4
C PARKINSON'S DISEASE PRURITUS 4
C PARKINSON'S DISEASE RASH MACULAR 4
C PARKINSON'S DISEASE TEMPERATURE INTOLERANCE 4
C PRODUCT USED FOR UNKNOWN INDICATION DYSGEUSIA 1
C PRODUCT USED FOR UNKNOWN INDICATION HYPOMANIA 2
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE ERYTHEMA 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE INDURATION 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE REACTION 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE SWELLING 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE URTICARIA 1
C PRODUCT USED FOR UNKNOWN INDICATION RHINORRHOEA 1
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