← FDA Drug Approvals (Drugs@FDA)
BREKIYA (AUTOINJECTOR)
NDA · New Drug Application · Sponsor: AMNEAL · Approved 2025-05-14
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown