Application 206765
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DALFAMPRIDINE | DALFAMPRIDINE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63629-9450 | Dalfampridine | Dalfampridine | Bryant Ranch Prepack | ANDA | Current |
| 67877-444 | Dalfampridine | Dalfampridine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-444 | Dalfampridine | Dalfampridine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-444 | Dalfampridine | Dalfampridine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-444 | Dalfampridine | Dalfampridine | Ascend Laboratories, LLC | ANDA | Current |