Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211236
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 600MG | TABLET;ORAL | Discontinued | None | No | No |
| ESLICARBAZEPINE ACETATE | ESLICARBAZEPINE ACETATE | 800MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/07/2023 | ORIG-1 | Approval | STANDARD |
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