Orange Book product · Brand (NDA)
MIGRANAL
DIHYDROERGOTAMINE MESYLATE
At a glance
Dec 08, 1997
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 08, 1997
28 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
DIHYDROERGOTAMINE MESYLATE
Strength
0.5MG/SPRAY
Dosage form
SPRAY, METERED
Route
NASAL
TE code
AB
Application
NDA 020148
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025BREKIYA (AUTOINJECTOR)Brand (NDA)
NDA 215400 · AMNEAL
- 2025ATZUMIBrand (NDA)
NDA 217901 · SATSUMA PHARMS
- 2021TRUDHESABrand (NDA)
NDA 213436 · IMPEL PHARMS
- —D.H.E. 45Brand (NDA)
NDA 005929 · BAUSCH
- 2025DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 215228 · SOMERSET THERAPS LLC
- 2025DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 216747 · BAXTER HLTHCARE CORP
- 2024DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 212334 · CIPLA
- 2023DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 215623 · GLAND
- 2023DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 216881 · RUBICON RESEARCH
- 2022DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 214105 · AMNEAL
- 2020DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 212907 · CIPLA
- 2020DIHYDROERGOTAMINE MESYLATEGeneric (ANDA)
ANDA 211393 · HIKMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
