Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Esmolol Hydrochloride Injection, American Pharma, Approval | Esmolol Hydrochloride Injection, PharmaForce, Approval | Brevibloc (esmolol hydrochloride) IV, Baxter Healthcare, Labeling Revision | Brevibloc, esmolol hydrochloride, Injectable; Injection, Baxter Hlthcare, Labeling Revision | Brevibloc Double Strength In Plastic Container, esmolol hydrochloride, Injectable; Injection, Baxter Hlthcare, Labeling Revision | Brevibloc In Plastic Container, esmolol hydrochloride, Injectable; Injection, Baxter Hlthcare, Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com