# EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
> **ANDA212373** · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2025-07-16
## Drug
- **FDA Application Number:** ANDA212373
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- **Generic name:** Empagliflozin
- **Active ingredients:** EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** MACLEODS PHARMS LTD
- **First approval:** 2025-07-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212373)
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