Application 216185
- Type
- NDA
- Sponsor
- AUCTA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MOTPOLY XR | LACOSAMIDE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | Yes | No |
| 002 | MOTPOLY XR | LACOSAMIDE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | Yes | No |
| 003 | MOTPOLY XR | LACOSAMIDE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | Yes | Yes |