approval · primary record
DIHYDROERGOTAMINE MESYLATE
2 approval events · latest 2025-05-14
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-05-14 |
| Approval events | 2 |
| Brand | BREKIYA (AUTOINJECTOR) |
| Sponsor | AMNEAL |
| Route | SUBCUTANEOUS |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2025-05-14 | FDA | NDA | BREKIYA (AUTOINJECTOR) | AMNEAL | SUBCUTANEOUS |
| 2025-04-30 | FDA | NDA | ATZUMI | SATSUMA PHARMS | NASAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:31:18.035Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:dihydroergotamine-mesylate
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Dihydroergotamine Mesylate · compound