Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077795
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
11/25/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/06/2012 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

08/29/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

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

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