From USFDAWockhardt announced that the abbreviated new drug application ('ANDA') of Piperacillin and Tazobactam for Injection USP, 40.5 g/vial, pharmacy bulk package submitted by Wockhardt Bio AG (Wockhardt), Subsidiary of the Company has been approved by U.S. Food and Drug Administration ('USFDA').
Wockhardt's ANDA was determined to be therapeutically equivalent to the reference listed drug (RLD) Zosyn for Injection 40.5g/vial, pharmacy bulk package of Wyeth Pharmaceuticals Inc.
Wockhardt Bio AG had filed this ANDA in collaboration with Fresinius Kabi, Italy (FKAI), where the product development was completed. The ANDA will be manufactured commercially at FKAI, Mitim, Italy.
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