Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022416
Company: SUNOVION PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APTIOM ESLICARBAZEPINE ACETATE 200MG TABLET;ORAL Prescription None Yes No
APTIOM ESLICARBAZEPINE ACETATE 400MG TABLET;ORAL Prescription None Yes No
APTIOM ESLICARBAZEPINE ACETATE 600MG TABLET;ORAL Prescription None Yes No
APTIOM ESLICARBAZEPINE ACETATE 800MG TABLET;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
11/08/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022416s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022416Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/13/2017 SUPPL-9 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022416s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022416Orig1s009ltr.pdf
03/07/2017 SUPPL-6 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022416Orig1s006ltr.pdf
01/06/2016 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/10/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/11/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/27/2015 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022416s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022416Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/13/2017 SUPPL-9 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022416s009lbl.pdf
08/27/2015 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022416s001lbl.pdf
11/08/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022416s000lbl.pdf

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