# EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
> **ANDA218483** · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON PHARMA INC · Approved 2024-10-15
## Drug
- **FDA Application Number:** ANDA218483
- **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:** PRINSTON PHARMA INC
- **First approval:** 2024-10-15
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218483)
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