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

Indications And Usage Finasteride Is 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.

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

Comments