Application Nr Approved Date Route Status External Links
NDA020180 1992-06-19 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Proscar, 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 Acute Urinary Retention Reduce The Risk Of The Need For Surgery Including Transurethral Resection Of The Prostate (turp) And Prostatectomy. Proscar 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) (1.2). Limitations Of Use: Proscar Is Not Approved For The Prevention Of Prostate Cancer (1.3). 1.1 Monotherapy Proscar® Is Indicated For The Treatment Of Symptomatic Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate To: Improve Symptoms Reduce The Risk Of Acute Urinary Retention Reduce The Risk Of The Need For Surgery Including Transurethral Resection Of The Prostate (turp) And Prostatectomy. 1.2 Combination With Alpha-Blocker Proscar 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 Proscar Is Not Approved For The Prevention Of Prostate Cancer.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
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. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
6. Docusate Sodium DOCUSATE SODIUM Molecular

Active Ingredients ( 1 Total)

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

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