Finasteride

Product manufactured by Hetero Labs Limited

Application Nr Approved Date Route Status External Links
ANDA090061 2010-06-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Finasteride Tablets Usp, 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 Usp 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: Finasteride Tablets Usp 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 Tablets Usp 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 Usp Are Not Approved For The Prevention Of Prostate Cancer.

All Formulated Excipients (7 Total)

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

Active Ingredients ( 1 Total)

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

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