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FDA Approval

EMSAM

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Mylan Specialty L.P.
DUNS: 194775557
Effective Date
May 15, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Selegiline(9 mg in 24 h)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

EMSAM

Product Details

NDC Product Code
49502-901
Application Number
NDA021336
Marketing Category
NDA (C73594)
Route of Administration
TRANSDERMAL
Effective Date
May 15, 2020
Code: 2K1V7GP655Class: ACTIBQuantity: 9 mg in 24 h

EMSAM

Product Details

NDC Product Code
49502-900
Application Number
NDA021336
Marketing Category
NDA (C73594)
Route of Administration
TRANSDERMAL
Effective Date
May 15, 2020
Code: 2K1V7GP655Class: ACTIBQuantity: 6 mg in 24 h

EMSAM

Product Details

NDC Product Code
49502-902
Application Number
NDA021336
Marketing Category
NDA (C73594)
Route of Administration
TRANSDERMAL
Effective Date
May 15, 2020
Code: 2K1V7GP655Class: ACTIBQuantity: 12 mg in 24 h
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