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ZAYNICH

NDA · New Drug Application · Sponsor: WOCKHARDT BIO AG · Approved 2026-05-29

Drug application

FDA Application #

NDA220787

Application type

New Drug Application

Brand name

ZAYNICH

Generic name

ZIDEBACTAM DIHYDRATE AND CEFEPIME HYDROCHLORIDE

Active ingredients

CEFEPIME HYDROCHLORIDE; ZIDEBACTAM

Dosage form

POWDER

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

WOCKHARDT BIO AG

Manufacturer

Wockhardt Suisse USA LLC

First approval

2026-05-29

Source

Authoritative

Drugs@FDA application overview

Machine

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