# SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
> **ANDA214494** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2026-03-10
## Drug
- **FDA Application Number:** ANDA214494
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
- **Generic name:** Metformin Hydrochloride, Sitagliptin
- **Active ingredients:** METFORMIN HYDROCHLORIDE, SITAGLIPTIN
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** —
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** APOTEX INC
- **First approval:** 2026-03-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214494)
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