Application Nr Approved Date Route Status External Links
ANDA204262 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 Soft Gelatin 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 (10 Total)

Name Structure Kind Function Status
1. Glycine GLYCINE Molecular MISC-Miscellaneous , NUTR-Nutrient , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
2. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
3. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
5. Medium-Chain Triglycerides MEDIUM-CHAIN TRIGLYCERIDES Unresolved
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Ferric Oxide Red FERRIC OXIDE RED Molecular
8. Polyvinyl Acetate Phthalate POLYVINYL ACETATE PHTHALATE Unresolved
9. Water WATER Molecular
10. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

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

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