← FDA Drug Approvals (Drugs@FDA)
AMBIEN CR
NDA · New Drug Application · Sponsor: COSETTE · Approved 2005-09-02
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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