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DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2026-04-06

Drug application

FDA Application #

ANDA211489

Application type

Abbreviated New Drug Application (Generic)

Brand name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Generic name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Active ingredients

DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

AUROBINDO PHARMA

Manufacturer

Aurobindo Pharma Limited

First approval

2026-04-06

Source

Authoritative

Drugs@FDA application overview

Machine

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