← FDA Drug Approvals (Drugs@FDA)
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
- Machine
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