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DAPAGLIFLOZIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS UNIT III · Approved 2019-01-18

Drug application

FDA Application #
ANDA211439
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
HETERO LABS UNIT III
First approval
2019-01-18

Source

Authoritative
Drugs@FDA application overview
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