# DIAZEPAM
> **ANDA216422** · Abbreviated New Drug Application (Generic) · Sponsor: GALENICUM HLTH · Approved 2025-05-19
## Drug
- **FDA Application Number:** ANDA216422
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DIAZEPAM
- **Generic name:** Diazepam
- **Active ingredients:** DIAZEPAM
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** GALENICUM HLTH
- **First approval:** 2025-05-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216422)
---
*AI Analytics · CC0 1.0*