# DIAZEPAM
> **ANDA219320** · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS ISRAEL PHARMA LTD · Approved 2025-11-12
## Drug
- **FDA Application Number:** ANDA219320
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DIAZEPAM
- **Generic name:** Diazepam
- **Active ingredients:** DIAZEPAM
- **Dosage form:** Spray
- **Route:** —
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** PADAGIS ISRAEL PHARMA LTD
- **First approval:** 2025-11-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219320)
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