Application Nr Approved Date Route Status External Links
ANDA078161 2013-11-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Finasteride Tablets, Usp Are Indicated For The Treatment Of Male Pattern Hair Loss (androgenetic Alopecia) In Men Only. Efficacy In Bitemporal Recession Has Not Been Established. Finasteride Tablets Are Not Indicated For Use In Women. •finasteride Tablets, Usp Are A 5α-Reductase Inhibitor Indicated For The Treatment Of Male Pattern Hair Loss (androgenetic Alopecia) In Men Only (1). •finasteride Tablets Are Not Indicated For Use In Women (1, 4, 5.1).

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Docusate Sodium DOCUSATE SODIUM Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Finasteride FINASTERIDE ZINC3782599

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