Application 205075
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RUFINAMIDE | RUFINAMIDE | TABLET;ORAL | 200MG | No | No |
| 002 | RUFINAMIDE | RUFINAMIDE | TABLET;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60687-643 | Rufinamide | Rufinamide | American Health Packaging | ANDA | Current |
| 68462-713 | rufinamide | rufinamide | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-714 | rufinamide | rufinamide | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 19621 | ORIG | 2016-05-26 |
| 32626 | ORIG | 2016-05-18 |