# SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
> **ANDA218069** · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS LTD · Approved 2025-05-28
## Drug
- **FDA Application Number:** ANDA218069
- **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:** NOVAST LABS LTD
- **First approval:** 2025-05-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218069)
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