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FDA Approval

Finasteride

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

FDA Approval Summary

Company
Effective Date
July 28, 2017
Labeling Type
Human Prescription Drug Label
Finasteride(1 mg in 1 1)

Products1

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

Finasteride

Product Details

NDC Product Code
31722-526
Application Number
ANDA090060
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 29, 2017
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Code: 57GNO57U7GClass: ACTIBQuantity: 1 mg in 1 1
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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