Application 211393
- Type
- ANDA
- Sponsor
- CUSTOPHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | SPRAY, METERED;NASAL | 0.5MG/SPRAY | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24201-463 | Dihydroergotamine Mesylate | Dihydroergotamine Mesylate | Leucadia Pharmaceuticals | ANDA | Current |
| 24201-463 | Dihydroergotamine Mesylate | Dihydroergotamine Mesylate | Leucadia Pharmaceuticals | ANDA | Current |
| 24201-463 | Dihydroergotamine Mesylate | Dihydroergotamine Mesylate | Leucadia Pharmaceuticals | ANDA | Current |
| 24201-463 | Dihydroergotamine Mesylate | Dihydroergotamine Mesylate | Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals) | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62168 | ORIG | 2020-03-17 |