Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022345
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTIGA EZOGABINE 50MG TABLET;ORAL Discontinued None Yes No
POTIGA EZOGABINE 200MG TABLET;ORAL Discontinued None Yes No
POTIGA EZOGABINE 300MG TABLET;ORAL Discontinued None Yes No
POTIGA EZOGABINE 400MG TABLET;ORAL Discontinued None Yes 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
06/10/2011 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022345s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/20/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022345s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022345Orig1s011ltr.pdf
05/26/2015 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022345s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022345Orig1s010ltr.pdf
11/25/2015 SUPPL-9 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022345Orig1s009Ltr.pdf
06/06/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022345Orig1s007ltr.pdf
09/06/2013 SUPPL-6 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022345Orig1s006ltr.pdf
11/21/2012 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/19/2012 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022345s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/20/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022345s011lbl.pdf
05/26/2015 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022345s010lbl.pdf
09/06/2013 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s006lbl.pdf
06/06/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s007lbl.pdf
03/19/2012 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf
03/19/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf
03/19/2012 SUPPL-1 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf
06/10/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf

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