Application Nr Approved Date Route Status External Links
ANDA076511 2006-12-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Finasteride Tablets Are 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 Is 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 (0 Total)

None

Active Ingredients ( 1 Total)

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

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