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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022345
Company: GLAXOSMITHKLINE

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 022345

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022345

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

Labels for NDA 022345

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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