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FDA Approval

SELEGILINE HYDROCHLORIDE

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

FDA Approval Summary

Company
Effective Date
August 4, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Selegiline(5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Carilion Materials Management

Carilion Materials Management

079239644

Products1

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

SELEGILINE HYDROCHLORIDE

Product Details

NDC Product Code
68151-2649
Application Number
ANDA075352
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 3, 2011
Code: 6W731X367QClass: ACTIBQuantity: 5 mg in 1 1
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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