← FDA Drug Approvals (Drugs@FDA)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2026-04-06
Drug application
- FDA Application #
ANDA211563- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Generic name
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Active ingredients
- DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKEM LABS LTD
- Manufacturer
- Ascend Laboratories, LLC
- First approval
- 2026-04-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown