Application 022416
- Type
- NDA
- Sponsor
- SUNOVION PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | APTIOM | ESLICARBAZEPINE ACETATE | TABLET;ORAL | 200MG | Yes | No |
| 002 | APTIOM | ESLICARBAZEPINE ACETATE | TABLET;ORAL | 400MG | Yes | No |
| 003 | APTIOM | ESLICARBAZEPINE ACETATE | TABLET;ORAL | 600MG | Yes | No |
| 004 | APTIOM | ESLICARBAZEPINE ACETATE | TABLET;ORAL | 800MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63402-202 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-202 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-202 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-204 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-204 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-204 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-206 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-206 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-206 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-208 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-208 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-208 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-248 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-248 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals | NDA | Current |
| 63402-248 | Aptiom | ESLICARBAZEPINE ACETATE | Sunovion Pharmaceuticals Inc. | NDA | Current |