Dutasteride

Product manufactured by Impax Generics

Application Nr Approved Date Route Status External Links
ANDA200899 2015-11-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dutasteride Is 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 In Combination With The Alpha Adrenergic Antagonist, Tamsulosin, Is Indicated For The Treatment Of Symptomatic Bph In Men With An Enlarged Prostate. (1.2) Limitations Of Use: Dutasteride Is 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 In Combination With The Alpha Adrenergic Antagonist, Tamsulosin, Is Indicated For The Treatment Of Symptomatic Bph In Men With An Enlarged Prostate. 1.3 Limitations Of Use Dutasteride Is 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. Ferrosoferric Oxide FERROSOFERRIC OXIDE Unresolved
3. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

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

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