Application 205152
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
| 002 | ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | TABLET;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4287 | Eletriptan Hydrobromide | eletriptan hydrobromide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4287 | Eletriptan Hydrobromide | eletriptan hydrobromide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4288 | Eletriptan Hydrobromide | eletriptan hydrobromide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4288 | Eletriptan Hydrobromide | eletriptan hydrobromide | Mylan Pharmaceuticals Inc. | ANDA | Current |