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Wockhardt receives ANDA approval for Piperacillin and Tazobactam for Injection

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From USFDA

announced that the abbreviated new drug application ('ANDA') of Piperacillin and Tazobactam for Injection USP, 40.5 g/vial, pharmacy bulk package submitted by 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.

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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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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Wockhardt receives ANDA approval for Piperacillin and Tazobactam for Injection

From USFDA

From USFDA

announced that the abbreviated new drug application ('ANDA') of Piperacillin and Tazobactam for Injection USP, 40.5 g/vial, pharmacy bulk package submitted by 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.

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.

Powered by Capital Market - Live News

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

image
Business Standard
177 22

Wockhardt receives ANDA approval for Piperacillin and Tazobactam for Injection

From USFDA

announced that the abbreviated new drug application ('ANDA') of Piperacillin and Tazobactam for Injection USP, 40.5 g/vial, pharmacy bulk package submitted by 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.

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.

Powered by Capital Market - Live News

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

image
Business Standard
177 22