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… Brevibloc Concentrate (Esmolol Hydrochloride), 10 mg/mL Ampuls, Baxter NDA 19-386/S24 8/18/03 8/26/03 Brevibloc (Esmolol Hydrochloride) Injection, 10 mg/mL Vial, Baxter Pharmaceutical Products NDA 19-386/S21 2/25/03 3/10/03 7/8/03 Brevibloc Premixed Injection (esmolol hydrochloride) and Brevibloc Double Strength Premixed Injection, Baxter Healthcare NDA 19-386/S19 & S20 1/27/03 2/12/03 Brevibloc (Esmolol Hydrochloride) Injection, 250 mg/mL Ampule & 10 mg/mL Vial, Baxter Pharmaceutical Products NDA 19-386 Esmolol Hydrochloride Concentrate, 250 mg/mL, Pharmaforce ANDA 76-456 6/26/03 Esmolol Hydrochloride Concentrate, 250 mg/mL, Bedford ANDA 76-326 6/26/03 Esmolol Hydrochloride Injection, 10 mg/mL, PharmaForce, ANDA 76-474 6/26/03 Esmolol Hydrochloride Injection, 10 mg/mL, Bedford ANDA 76-323 Esmolol Hydrochloride Injection, Bedford Labs, Approval   For the latest approval information, locate this drug using this index.