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ZITUVIMET XR

NDA · New Drug Application · Sponsor: ZYDUS LIFESCIENCES · Approved 2024-07-18

Drug application

FDA Application #

NDA216778

Application type

New Drug Application

Brand name

ZITUVIMET XR

Generic name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Active ingredients

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS LIFESCIENCES

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2024-07-18

Source

Authoritative

Drugs@FDA application overview

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