General MedicationsRECTALStandard
DIAZEPAM
DIAZEPAM
Standard Dose
2.5MG/0.5ML (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 217468 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DIAZEPAM Form and strength GEL;RECTAL - 2.5MG/0.5ML (5MG/ML) Sponsor NAVINTA LLC Submission history Latest submission status date: 2025-11-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview DIAZEPAM is listed in Drugs@FDA under application 217468 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DIAZEPAM Form and strength GEL;RECTAL - 2.5MG/0.5ML (5MG/ML) Sponsor NAVINTA LLC Submission history Latest submission status date: 2025-11-14 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.