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SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2023-07-31

Drug application

FDA Application #
ANDA205981
Application type
Abbreviated New Drug Application (Generic)
Brand name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Generic name
SAXAGLIPTIN AND METFORMIN
Active ingredients
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
MYLAN
Manufacturer
Mylan Pharmaceuticals Inc.
First approval
2023-07-31

Source

Authoritative
Drugs@FDA application overview
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