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DAPAGLIFLOZIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2019-01-04

Drug application

FDA Application #

ANDA211442

Application type

Abbreviated New Drug Application (Generic)

Brand name

DAPAGLIFLOZIN

Generic name

Dapagliflozin

Active ingredients

DAPAGLIFLOZIN

Dosage form

TABLET

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

APOTEX INC

First approval

2019-01-04

Source

Authoritative

Drugs@FDA application overview

Machine

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