General MedicationsINJECTIONStandard
DIAZEPAM
DIAZEPAM
Standard Dose
50MG/10ML (5MG/ML)
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 216422 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DIAZEPAM Form and strength INJECTABLE;INJECTION - 50MG/10ML (5MG/ML) Sponsor GALENICUM HLTH Submission history Latest submission status date: 2025-05-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview DIAZEPAM is listed in Drugs@FDA under application 216422 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DIAZEPAM Form and strength INJECTABLE;INJECTION - 50MG/10ML (5MG/ML) Sponsor GALENICUM HLTH Submission history Latest submission status date: 2025-05-19 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.