Finasteride

Product manufactured by Unit Dose Services

Application Nr Approved Date Route Status External Links
ANDA090507 2011-08-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Finasteride Tablets 5 Mgare 5α-Reductase Inhibitors, 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 5 Mgadministered 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) ( ). : Finasteride Tablets 5 Mg Are Not Approved For The Prevention Of Prostate Cancer ( ). 1.2 Limitations Of Use 1.3 1.1 Monotherapy Finasteride Tablets 5 Mg 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 5 Mg 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 5 Mg Are Not Approved For The Prevention Of Prostate Cancer.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Starch, Corn STARCH, CORN Unresolved
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Povidones POVIDONES Unresolved
5. Docusate Sodium DOCUSATE SODIUM Molecular
6. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
7. 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.
8. Hypromelloses HYPROMELLOSES Unresolved
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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