Dutasteride

Product manufactured by Apotex Corp.

Application Nr Approved Date Route Status External Links
ANDA204292 2015-11-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dutasteride Capsules Are A 5 Alpha-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 Acute Urinary Retention, And Reduce The Risk Of The Need For Bph-Related Surgery. Dutasteride Capsules In Combination With The Alpha Adrenergic Antagonist, Tamsulosin, Are Indicated For The Treatment Of Symptomatic Bph In Men With An Enlarged Prostate. (1.2) Limitations Of Use: Dutasteride Capsules Are Not Approved For The Prevention Of Prostate Cancer. (1.3) 1.1 Monotherapy Dutasteride Capsules Are Indicated For The Treatment Of Symptomatic Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate To: Improve Symptoms, Reduce The Risk Of Acute Urinary Retention (aur), And Reduce The Risk Of The Need For Bph-Related Surgery. 1.2 Combination With Alpha Adrenergic Antagonist Dutasteride Capsules In Combination With The Alpha Adrenergic Antagonist, Tamsulosin, Are Indicated For The Treatment Of Symptomatic Bph In Men With An Enlarged Prostate. 1.3 Limitations Of Use Dutasteride Capsules Are Not Approved For The Prevention Of Prostate Cancer.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Ferric Oxide Red FERRIC OXIDE RED Molecular
4. Shellac SHELLAC Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dutasteride DUTASTERIDE ZINC3932831

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