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… Fosinopril Sodium Tablets, 10, 20 & 40 mg, 7/10/2003 Geneva ANDA 76-188 7/10/03 Fosinopril Sodium Tablets, 10, 20 & 40 mg, 7/10/2003 Teva ANDA 76-139 Monopril (fosinopril soidum) Tablets, 10, 20, and 40 mg, Bristol-Myers Squibb Company NDA 19-915/S-037 5/27/03 8/25/03 Monopril (fosinopril soidum) Tablets, 10, 20, and 40 mg, Bristol-Myers Squibb Company NDA 19-915/S-032 Monopril and Monopril-HCT (fosinopril sodium/hydrochloride) Tablets, Bristol-Myers Fosinopril Sodium Tablets, Teva Fosinopril Sodium Tablets, Eon Labs, Fosinopril Sodium Tablets, Ranbaxy Fosinopril Sodium Tablets, Eon Labs Fosinopril Sodium & Hydrochlorothiazide Tablets, Ranbaxy, Tentative Approval   For the latest approval information, locate this drug using this index.