General MedicationsORALStandard
AMBIEN
ZOLPIDEM TARTRATE
Standard Dose
5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview AMBIEN is listed in Drugs@FDA under application 019908 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ZOLPIDEM TARTRATE Form and strength TABLET;ORAL - 5MG Sponsor COSETTE Submission history Latest submission status date: 2022-02-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview AMBIEN is listed in Drugs@FDA under application 019908 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ZOLPIDEM TARTRATE Form and strength TABLET;ORAL - 5MG Sponsor COSETTE Submission history Latest submission status date: 2022-02-23 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.