Application Nr Approved Date Route Status External Links
ANDA077578 2006-12-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Finasteride Is A 5α-Reductase Inhibitor, Indicated For The Treatment Of Symptomatic Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate To ( 1.1): Improve Symptoms Reduce The Risk Of The Need For Surgery Including Transurethral Resection Of The Prostate (turp) And Prostatectomy. Finasteride Tablets Administered In Combination With The Alpha-Blocker Doxazosin Are Indicated To Reduce The Risk Of Symptomatic Progression Of Bph (a Confirmed ≥ 4 Point Increase In American Urological Association (aua) Symptom Score) ( 1.2). Limitations Of Use: Finasteride Tablets Are Not Approved For The Prevention Of Prostate Cancer ( 1.3). 1.1 Monotherapy Finasteride Tablets Are Indicated For The Treatment Of Symptomatic Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate To: Improve Symptoms Reduce The Risk Of The Need For Surgery Including Transurethral Resection Of The Prostate (turp) And Prostatectomy. 1.2 Combination With Alpha-Blocker Finasteride Tablets Administered In Combination With The Alpha-Blocker Doxazosin Are Indicated To Reduce The Risk Of Symptomatic Progression Of Bph (a Confirmed ≥ 4 Point Increase In American Urological Association (aua) Symptom Score). 1.3 Limitations Of Use Finasteride Tablets Are Not Approved For The Prevention Of Prostate Cancer.

All Formulated Excipients (10 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
5. Hypromelloses HYPROMELLOSES Unresolved
6. 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.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

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

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