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METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2026-06-30

Drug application

FDA Application #
ANDA208535
Application type
Abbreviated New Drug Application (Generic)
Brand name
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE
Generic name
Metformin Hydrochloride
Active ingredients
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
ZYDUS PHARMS USA INC
First approval
2026-06-30

Source

Authoritative
Drugs@FDA application overview
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