Application Nr Approved Date Route Status External Links
ANDA077251 2006-12-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Finasteride Tablets Are 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. Finasterid 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 (6 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Polyethylene Glycol 6000 POLYETHYLENE GLYCOL 6000 Unresolved
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. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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