# EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
> **ANDA217049** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2025-11-25
## Drug
- **FDA Application Number:** ANDA217049
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
- **Generic name:** Empagliflozin
- **Active ingredients:** EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** ZYDUS PHARMS USA INC
- **First approval:** 2025-11-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217049)
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