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SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON PHARMACEUTICAL INC · Approved 2025-03-13

Drug application

FDA Application #
ANDA216885
Application type
Abbreviated New Drug Application (Generic)
Brand name
SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE
Generic name
Metformin Hydrochloride, Sitagliptin Phosphate
Active ingredients
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE
Dosage form
TABLET
Route
FILM COATED
Marketing status
None (Tentative Approval)
Sponsor
PRINSTON PHARMACEUTICAL INC
First approval
2025-03-13

Source

Authoritative
Drugs@FDA application overview
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