# AMBIEN CR
> **NDA021774** · New Drug Application · Sponsor: COSETTE · Approved 2005-09-02
## Drug
- **FDA Application Number:** NDA021774
- **Application type:** New Drug Application
- **Brand name:** AMBIEN CR
- **Generic name:** ZOLPIDEM TARTRATE
- **Active ingredients:** ZOLPIDEM TARTRATE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** COSETTE
- **Manufacturer:** Sanofi-Aventis U.S. LLC
- **First approval:** 2005-09-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021774)
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