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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
Major Pharmaceuticals
DUNS: 191427277
Effective Date
December 8, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Finasteride(5 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
0904-6830
Application Number
ANDA090061
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 6, 2019
Code: 57GNO57U7GClass: ACTIBQuantity: 5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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