Aurobindo Pharma gets final approval for Pantoprazole Sodium for Injection
From USFDA
Aurobindo Pharma announced that the Company has received final approval from the United States Food & Drug Administration to manufacture and market Pantoprazole Sodium for Injection, 40 mg/vial (single dose vial). This product is expected to be launched in Q1 FY 2016-17.The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Protonix I.V. for injection, 40 mg/vial, of Wyeth Pharmaceuticals, Inc.
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