Application 213436
- Type
- NDA
- Sponsor
- IMPEL NEUROPHARMA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | SPRAY;TOPICAL | 4MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 77530-725 | Trudhesa | Dihydroergotamine mesylate | Impel Pharmaceuticals Inc. | NDA | Current |
| 77530-725 | Trudhesa | Dihydroergotamine mesylate | Impel NeuroPharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71873 | ORIG | 2022-08-23 |
| 68579 | ORIG | 2021-09-10 |
| 68578 | ORIG | 2021-09-10 |
| 68548 | ORIG | 2021-09-07 |