Application 005929
- Type
- NDA
- Sponsor
- BAUSCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | D.H.E. 45 | DIHYDROERGOTAMINE MESYLATE | INJECTABLE;INJECTION | 1MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66490-041 | D.H.E. 45 | Dihydroergotamine Mesylate | Bausch Health US, LLC | NDA | Current |
| 66490-041 | D.H.E. 45 | Dihydroergotamine Mesylate | Bausch Health US, LLC | NDA | Current |
| 66490-041 | D.H.E. 45 | Dihydroergotamine Mesylate | Valeant Pharmaceuticals North America | NDA | Current |
| 66490-041 | D.H.E. 45 | Dihydroergotamine Mesylate | Bausch Health US, LLC | NDA | Current |