Application 207363
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RUFINAMIDE | RUFINAMIDE | SUSPENSION;ORAL | 40MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0528 | Rufinamide | Rufinamide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0528 | Rufinamide | Rufinamide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0528 | Rufinamide | Rufinamide | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57737 | ORIG | 2019-05-21 |