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Application 213338
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-490 | Dofetilide | Dofetilide | Accord Healthcare, Inc. | ANDA | Current |
| 16729-490 | Dofetilide | Dofetilide | Accord Healthcare, Inc. | ANDA | Current |
| 16729-490 | Dofetilide | Dofetilide | Accord Healthcare, Inc. | ANDA | Current |
| 16729-491 | Dofetilide | Dofetilide | Accord Healthcare, Inc. | ANDA | Current |
| 16729-491 | Dofetilide | Dofetilide | Accord Healthcare, Inc. | ANDA | Current |
| 16729-491 | Dofetilide | Dofetilide | Accord Healthcare, Inc. | ANDA | Current |
| 16729-492 | Dofetilide | Dofetilide | Accord Healthcare, Inc. | ANDA | Current |
| 16729-492 | Dofetilide | Dofetilide | Accord Healthcare, Inc. | ANDA | Current |
| 16729-492 | Dofetilide | Dofetilide | Accord Healthcare, Inc. | ANDA | Current |