General MedicationsORALStandard
DIAZEPAM
DIAZEPAM
Standard Dose
5MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview DIAZEPAM is listed in Drugs@FDA under application 206477 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DIAZEPAM Form and strength SOLUTION;ORAL - 5MG/5ML Sponsor CHARTWELL MOLECULAR Submission history Latest submission status date: 2023-01-17 00:00:00.
Structured Monograph
Clinical summary
Approval overview DIAZEPAM is listed in Drugs@FDA under application 206477 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DIAZEPAM Form and strength SOLUTION;ORAL - 5MG/5ML Sponsor CHARTWELL MOLECULAR Submission history Latest submission status date: 2023-01-17 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.