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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
December 27, 2023
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.

Golden State Medical Supply, Inc.

Golden State Medical Supply, Inc.

603184490

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
60429-176
Application Number
ANDA074871
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 27, 2023
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: 6W731X367QClass: ACTIBQuantity: 5 mg in 1 1
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