Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022416
Company: SUMITOMO PHARMA AM
Company: SUMITOMO PHARMA AM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| APTIOM | ESLICARBAZEPINE ACETATE | 200MG | TABLET;ORAL | Prescription | AB | Yes | No |
| APTIOM | ESLICARBAZEPINE ACETATE | 400MG | TABLET;ORAL | Prescription | AB | Yes | No |
| APTIOM | ESLICARBAZEPINE ACETATE | 600MG | TABLET;ORAL | Prescription | AB | Yes | No |
| APTIOM | ESLICARBAZEPINE ACETATE | 800MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/15/2019 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022416s011lbl.pdf | |
| 09/13/2017 | SUPPL-9 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022416s009lbl.pdf | |
| 08/27/2015 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022416s001lbl.pdf | |
| 11/08/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022416s000lbl.pdf |