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XIGDUO XR

NDA · New Drug Application · Sponsor: ASTRAZENECA AB · Approved 2014-10-29

Drug application

FDA Application #

NDA205649

Application type

New Drug Application

Brand name

XIGDUO XR

Generic name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Active ingredients

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ASTRAZENECA AB

Manufacturer

Prasco Laboratories

First approval

2014-10-29

Source

Authoritative

Drugs@FDA application overview

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