Application Nr Approved Date Route Status External Links
ANDA078371 2013-11-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & 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, Usp Are Not Indicated For Use In Women. Finasteride Is 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 (7 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Ferric Oxide Red FERRIC OXIDE RED Molecular
3. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polyethylene Glycol 6000 POLYETHYLENE GLYCOL 6000 Unresolved

Active Ingredients ( 1 Total)

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

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