Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202810
Company: SUPERNUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXTELLAR XR OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXTELLAR XR OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXTELLAR XR OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/19/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202810Org1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202810_oxtellarxr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202810Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/17/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/23/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/04/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202810s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202810Orig1s005ltr.pdf
09/11/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/23/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/14/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/04/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202810s005lbl.pdf
10/19/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000lbl.pdf

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