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GLYBURIDE AND METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2016-02-29

Drug application

FDA Application #

ANDA206748

Application type

Abbreviated New Drug Application (Generic)

Brand name

GLYBURIDE AND METFORMIN HYDROCHLORIDE

Generic name

GLYBURIDE AND METFORMIN HYDROCHLORIDE

Active ingredients

GLYBURIDE; METFORMIN HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals (USA) Inc.

First approval

2016-02-29

Source

Authoritative

Drugs@FDA application overview

Machine

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