Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… AVODART (dutasteride) soft-gelatin capsules, GlaxoSmithKline NDA 21-319/S-001 Duagen (Dutasteride) Soft gel Capsules, 0.5 mg, GlaxoSmithKline NDA 21-319 11/20/01 1/14/02 Dutasteride Indications: for the signs and symptoms of benign prostatic hyperplasia. AVODART (dutasteride) soft-gelatin capsules, GlaxoSmithKline Avodart (dutasteride) soft-gelatin capsules, GlaxoSmithKline, Labeling Revision   For the latest approval information, locate this drug using this index.