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EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2026-02-25

Drug application

FDA Application #

ANDA220511

Application type

Abbreviated New Drug Application (Generic)

Brand name

EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Generic name

Empagliflozin, Metformin Hydrochloride

Active ingredients

EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

—

Marketing status

None (Tentative Approval)

Sponsor

AJANTA PHARMA LTD

First approval

2026-02-25

Source

Authoritative

Drugs@FDA application overview

Machine

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