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SYNJARDY XR

NDA · New Drug Application · Sponsor: BOEHRINGER INGELHEIM · Approved 2016-12-09

Drug application

FDA Application #

NDA208658

Application type

New Drug Application

Brand name

SYNJARDY XR

Generic name

EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE

Active ingredients

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

BOEHRINGER INGELHEIM

Manufacturer

Boehringer Ingelheim Pharmaceuticals, Inc.

First approval

2016-12-09

Source

Authoritative

Drugs@FDA application overview

Machine

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