Application Nr Approved Date Route Status External Links
ANDA076436 2006-07-28 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 Tablet 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 (8 Total)

Name Structure Kind Function Status
1. Docusate Sodium DOCUSATE SODIUM Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
7. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Ferric Oxide Red FERRIC OXIDE RED Molecular

Active Ingredients ( 1 Total)

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

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