# BREKIYA (AUTOINJECTOR)
> **NDA215400** · New Drug Application · Sponsor: AMNEAL · Approved 2025-05-14
## Drug
- **FDA Application Number:** NDA215400
- **Application type:** New Drug Application
- **Brand name:** BREKIYA (AUTOINJECTOR)
- **Generic name:** DIHYDROERGOTAMINE MESYLATE
- **Active ingredients:** DIHYDROERGOTAMINE MESYLATE
- **Dosage form:** SOLUTION
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL
- **Manufacturer:** Amneal Pharmaceuticals LLC
- **First approval:** 2025-05-14
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215400)
---
*MORVS · CC0 1.0*