Application 210740
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOFETILDE | DOFETILIDE | CAPSULE;ORAL | 0.125MG | No | No |
| 002 | DOFETILDE | DOFETILIDE | CAPSULE;ORAL | 0.25MG | No | No |
| 003 | DOFETILDE | 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 |
|---|
| 59651-118 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-118 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-118 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-118 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-119 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-119 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-119 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-119 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-120 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-120 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-120 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-120 | Dofetilide | Dofetilide | Aurobindo Pharma Limited | ANDA | Current |