Skip to contentApplication 208625
- Type
- ANDA
- Sponsor
- BIONPHARMA INC
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 |
|---|
| 69452-131 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-131 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-131 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-131 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-132 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-132 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-132 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-132 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-133 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-133 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-133 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |
| 69452-133 | Dofetilide | Dofetilide | Bionpharma Inc. | ANDA | Current |