Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201193
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 10/03/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/28/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/24/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/24/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |