# DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
> **ANDA211559** · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2026-04-06
## Drug
- **FDA Application Number:** ANDA211559
- **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:** MACLEODS PHARMS LTD
- **Manufacturer:** Macleods Pharmaceuticals Limited
- **First approval:** 2026-04-06
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211559)
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