Application Nr Approved Date Route Status External Links
ANDA202509 2014-02-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dutasteride And Tamsulosin Hydrochloride Capsules Are A Combination Of Dutasteride, A 5 Alpha-Reductase Inhibitor, And Tamsulosin, An Alpha Adrenergic Antagonist, Indicated For The Treatment Of Symptomatic Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate. (1.1) Limitations Of Use: Dutasteride-Containing Products, Including Dutasteride And Tamsulosin Hydrochloride Capsules, Are Not Approved For The Prevention Of Prostate Cancer. (1.2) 1.1 Benign Prostatic Hyperplasia (bph) Treatment Dutasteride And Tamsulosin Hydrochloride Capsules Are Indicated For The Treatment Of Symptomatic Bph In Men With An Enlarged Prostate. 1.2 Limitations Of Use Dutasteride-Containing Products, Including Dutasteride And Tamsulosin Hydrochloride Capsules, Are Not Approved For The Prevention Of Prostate Cancer.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
3. Lecithin LECITHIN Unresolved
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
6. Polyvinyl Acetate Phthalate POLYVINYL ACETATE PHTHALATE Unresolved

Active Ingredients ( 2 Total)

Comments