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DAPAGLIFLOZIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: JIANGSU HANSOH PHARM · Approved 2026-04-02

Drug application

FDA Application #
ANDA216119
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
JIANGSU HANSOH PHARM
First approval
2026-04-02

Source

Authoritative
Drugs@FDA application overview
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