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Selegiline Hydrochloride

Selegiline Hydrochloride Tablets USP 5 mg

Approved
Approval ID

040a97e5-efd1-4a2f-b737-2f13e5366d70

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2023

Manufacturers
FDA

Golden State Medical Supply, Inc.

DUNS: 603184490

Products 1

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

Selegiline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60429-176
Application NumberANDA074871
Product Classification
M
Marketing Category
C73584
G
Generic Name
Selegiline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification

INGREDIENTS (5)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SELEGILINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 6W731X367Q
Classification: ACTIB

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Selegiline Hydrochloride - FDA Drug Approval Details