Orange Book product · Brand (NDA)
D.H.E. 45
DIHYDROERGOTAMINE MESYLATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DIHYDROERGOTAMINE MESYLATE
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 005929
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
- 1997MIGRANALBrand (NDA)
NDA 020148 · 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.
