# XIGDUO XR
> **NDA205649** · New Drug Application · Sponsor: ASTRAZENECA AB · Approved 2014-10-29
## Drug
- **FDA Application Number:** NDA205649
- **Application type:** New Drug Application
- **Brand name:** XIGDUO XR
- **Generic name:** DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- **Active ingredients:** DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ASTRAZENECA AB
- **Manufacturer:** Prasco Laboratories
- **First approval:** 2014-10-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205649)
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