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SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2025-06-04

Drug application

FDA Application #
ANDA204144
Application type
Abbreviated New Drug Application (Generic)
Brand name
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Generic name
Metformin Hydrochloride
Active ingredients
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
PH HEALTH
First approval
2025-06-04

Source

Authoritative
Drugs@FDA application overview
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