Skip to contentApplication 207058
- Type
- ANDA
- Sponsor
- MAYNE PHARMA 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 |
|---|
| 0904-6681 | Dofetilide | Dofetilide | Major Pharmaceuticals | ANDA | Current |
| 0904-6682 | Dofetilide | Dofetilide | Major Pharmaceuticals | ANDA | Current |
| 0904-6683 | Dofetilide | Dofetilide | Major Pharmaceuticals | ANDA | Current |
| 16714-840 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-840 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-840 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-840 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-841 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-841 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-841 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-841 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-842 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-842 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-842 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 16714-842 | Dofetilide | Dofetilide | Northstar Rx LLC | ANDA | Current |
| 51862-005 | Dofetilide | Dofetilide | Mayne Pharma Inc. | ANDA | Current |
| 51862-005 | Dofetilide | Dofetilide | Mayne Pharma Inc. | ANDA | Current |
| 51862-005 | Dofetilide | Dofetilide | Mayne Pharma Inc. | ANDA | Current |
| 51862-025 | Dofetilide | Dofetilide | Mayne Pharma Inc. | ANDA | Current |
| 51862-025 | Dofetilide | Dofetilide | Mayne Pharma Inc. | ANDA | Current |
| 51862-025 | Dofetilide | Dofetilide | Mayne Pharma Inc. | ANDA | Current |
| 51862-125 | Dofetilide | Dofetilide | Mayne Pharma Inc. | ANDA | Current |
| 51862-125 | Dofetilide | Dofetilide | Mayne Pharma Inc. | ANDA | Current |
| 51862-125 | Dofetilide | Dofetilide | Mayne Pharma Inc. | ANDA | Current |
| 71410-300 | Dofetilide | Dofetilide | Liberty Bioscience LLC | ANDA | Current |
| 71410-301 | Dofetilide | Dofetilide | Liberty Bioscience LLC | ANDA | Current |
| 71410-302 | Dofetilide | Dofetilide | Liberty Bioscience LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 40580 | ORIG | 2016-06-10 |
| 10610 | ORIG | 2016-06-08 |