Selegiline Hydrochloride
Selegiline Hydrochloride Tablets USP 5 mg
Approved
Approval ID
f286c854-3b8c-44a8-b3b5-c828dbabb207
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-2918
Application NumberANDA074871
Product Classification
M
Marketing Category
C73584
G
Generic Name
Selegiline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2018
FDA Product Classification
INGREDIENTS (5)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SELEGILINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 6W731X367Q
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT