Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077795
Company: HIKMA
Company: HIKMA
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 |
---|---|---|---|---|---|---|---|
10/09/2007 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077795s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077795s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/26/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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08/26/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
11/25/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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01/06/2012 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
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08/29/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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06/29/2010 | SUPPL-3 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/09/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077795s000lbl.pdf |