# ZITUVIMET XR
> **NDA216778** · New Drug Application · Sponsor: ZYDUS LIFESCIENCES · Approved 2024-07-18
## Drug
- **FDA Application Number:** NDA216778
- **Application type:** New Drug Application
- **Brand name:** ZITUVIMET XR
- **Generic name:** SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
- **Active ingredients:** METFORMIN HYDROCHLORIDE; SITAGLIPTIN
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ZYDUS LIFESCIENCES
- **Manufacturer:** Zydus Pharmaceuticals USA Inc.
- **First approval:** 2024-07-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216778)
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