Application Nr Approved Date Route Status External Links
ANDA091643 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 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 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. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. 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.
4. Hypromelloses HYPROMELLOSES Unresolved
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Ferric Oxide Red FERRIC OXIDE RED Molecular

Active Ingredients ( 1 Total)

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

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