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JANUMET XR

NDA · New Drug Application · Sponsor: MSD SUB MERCK · Approved 2012-02-02

Drug application

FDA Application #
NDA202270
Application type
New Drug Application
Brand name
JANUMET XR
Generic name
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Active ingredients
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
MSD SUB MERCK
Manufacturer
Merck Sharp & Dohme LLC
First approval
2012-02-02

Source

Authoritative
Drugs@FDA application overview
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