Application Nr Approved Date Route Status External Links
ANDA077914 2007-03-28 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 Administered In Combination With The Alpha-Blocker Doxazosin Is Indicated To Reduce The Risk Of Symptomatic Progression Of Bph (a Confirmed Greater Than Or Equal To 4 Point Increase In American Urological Association (aua) Symptom Score) (1.2). Limitations Of Use: Finasteride Is Not Approved For The Prevention Of Prostate Cancer (1.3). 1.1 Monotherapy Finasteride Tablets, Usp 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 Administered In Combination With The Alpha-Blocker Doxazosin Is Indicated To Reduce The Risk Of Symptomatic Progression Of Bph (a Confirmed Greater Than Or Equal To 4 Point Increase In American Urological Association (aua) Symptom Score). 1.3 Limitations Of Use Finasteride Is Not Approved For The Prevention Of Prostate Cancer.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

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

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