# DAPAGLIFLOZIN
> **ANDA211582** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2026-04-06
## Drug
- **FDA Application Number:** ANDA211582
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DAPAGLIFLOZIN
- **Generic name:** DAPAGLIFLOZIN
- **Active ingredients:** DAPAGLIFLOZIN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ZYDUS PHARMS
- **Manufacturer:** Zydus Lifesciences 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=211582)
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*MORVS · CC0 1.0*