General MedicationsSprayGeneric
DIAZEPAM
DIAZEPAM
Standard Dose
10MG/1SPRAY
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary
Approval overview DIAZEPAM is listed in Drugs@FDA under application 219320 (ANDA).
Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DIAZEPAM Form and strength Spray - 10MG/1SPRAY Sponsor PADAGIS ISRAEL PHARMA LTD Submission history Latest submission status date: 2025-11-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview DIAZEPAM is listed in Drugs@FDA under application 219320 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DIAZEPAM Form and strength Spray - 10MG/1SPRAY Sponsor PADAGIS ISRAEL PHARMA LTD Submission history Latest submission status date: 2025-11-12 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: None (Tentative Approval)
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.