← FDA Drug Approvals (Drugs@FDA)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: INVENTIA HEALTHCARE LIMITED · Approved 2026-04-09
Drug application
- FDA Application #
ANDA219755- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Generic name
- Dapagliflozin, Metformin Hydrochloride
- Active ingredients
- DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- INVENTIA HEALTHCARE LIMITED
- First approval
- 2026-04-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown