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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
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