FdaApplication
NDA 022416
Identifiers
- fda_app_no: NDA022416
Properties
| Property | Value |
|---|---|
| applicant_name | SUMITOMO PHARMA AMERICA INC |
| application_type | NDA |
| approval_date | 2013-11-08 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| APTIOM | ESLICARBAZEPINE ACETATE | 600MG | TABLET;ORAL |
| APTIOM | ESLICARBAZEPINE ACETATE | 400MG | TABLET;ORAL |
| APTIOM | ESLICARBAZEPINE ACETATE | 200MG | TABLET;ORAL |
| APTIOM | ESLICARBAZEPINE ACETATE | 800MG | TABLET;ORAL |
4 products