Application 212750
- Type
- ANDA
- Sponsor
- GRANULES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOFETILIDE | DOFETILIDE | CAPSULE;ORAL | 0.125MG | No | No |
| 002 | DOFETILIDE | DOFETILIDE | CAPSULE;ORAL | 0.25MG | No | No |
| 003 | DOFETILIDE | DOFETILIDE | CAPSULE;ORAL | 0.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70010-024 | Dofetilide 0.125mg | Dofetilide 0.125mg | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-025 | Dofetilide 0.25mg | Dofetilide 0.25mg | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-026 | Dofetilide 0.5mg | Dofetilide 0.5mg | Granules Pharmaceuticals Inc. | ANDA | Current |