Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078005
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET;ORAL | Discontinued | None | No | No |
| OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET;ORAL | Discontinued | None | No | No |
| OXCARBAZEPINE | OXCARBAZEPINE | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/11/2007 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/078005_bioeq_rev-oxcarbazepine tabs.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/27/2020 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2020 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2010 | SUPPL-2 | Labeling |
Label is not available on this site. |