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SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN LABORATORIES PRIVATE LTD · Approved 2025-11-17

Drug application

FDA Application #
ANDA217395
Application type
Abbreviated New Drug Application (Generic)
Brand name
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Generic name
Sitagliptin Phosphate Anhydrous, Metformin Hydrochloride
Active ingredients
SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE
Dosage form
TABLET
Route
—
Marketing status
None (Tentative Approval)
Sponsor
MSN LABORATORIES PRIVATE LTD
First approval
2025-11-17

Source

Authoritative
Drugs@FDA application overview
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