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SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2026-03-10

Drug application

FDA Application #

ANDA214494

Application type

Abbreviated New Drug Application (Generic)

Brand name

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Generic name

Metformin Hydrochloride, Sitagliptin

Active ingredients

METFORMIN HYDROCHLORIDE, SITAGLIPTIN

Dosage form

TABLET, EXTENDED RELEASE

Route

—

Marketing status

None (Tentative Approval)

Sponsor

APOTEX INC

First approval

2026-03-10

Source

Authoritative

Drugs@FDA application overview

Machine

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