EMSAM
These highlights do not include all the information needed to use EMSAM safely and effectively. See full prescribing information for EMSAM. EMSAM (selegiline transdermal system) Initial U.S. Approval: 2006
Approved
Approval ID
b891bd9f-fdb8-4862-89c5-ecdd700398a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2020
Manufacturers
FDA
Mylan Specialty L.P.
DUNS: 194775557
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
selegiline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49502-901
Application NumberNDA021336
Product Classification
M
Marketing Category
C73594
G
Generic Name
selegiline
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMay 15, 2020
FDA Product Classification
INGREDIENTS (1)
SELEGILINEActive
Quantity: 9 mg in 24 h
Code: 2K1V7GP655
Classification: ACTIB
selegiline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49502-900
Application NumberNDA021336
Product Classification
M
Marketing Category
C73594
G
Generic Name
selegiline
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMay 15, 2020
FDA Product Classification
INGREDIENTS (1)
SELEGILINEActive
Quantity: 6 mg in 24 h
Code: 2K1V7GP655
Classification: ACTIB
selegiline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49502-902
Application NumberNDA021336
Product Classification
M
Marketing Category
C73594
G
Generic Name
selegiline
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMay 15, 2020
FDA Product Classification
INGREDIENTS (1)
SELEGILINEActive
Quantity: 12 mg in 24 h
Code: 2K1V7GP655
Classification: ACTIB