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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
Proficient Rx LP
DUNS: 079196022
Effective Date
February 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Finasteride(5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Proficient Rx LP

Proficient Rx LP

079196022

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
71205-767
Application Number
ANDA204304
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 1, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: 57GNO57U7GClass: ACTIBQuantity: 5 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
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