Aurobindo Pharma gets final approval for Esmolol Hydrochloride Injection

From USFDA

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Esmolol Hydrochloride Injection, 100mg/10mL (10mg/mL), (ANDA 205520).

Esmolol Hydrochloride Injection, 100mg/10mL (10mg/mL) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Brevibloc Injection, 10mg/mL of Baxter Healthcare Corporation. Esmolol Hydrochloride Injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period.

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