NDA 022345

GLAXOSMITHKLINE

FDA Drug Application

Application #022345

Documents

• Letter: 2013-06-07
• Letter: 2015-11-27
• Label: 2011-06-16
• Label: 2012-03-19
• Label: 2013-06-11
• Label: 2016-05-23
• Review: 2011-07-11
• Other Important Information from FDA: 2013-11-01
• Letter: 2011-06-15
• Letter: 2012-03-23
• Letter: 2013-09-11
• Letter: 2015-05-28
• Letter: 2016-05-24
• Label: 2013-09-09
• Label: 2015-05-29
• Medication Guide: 2011-06-17
• Summary Review: 2011-07-11

Application Sponsors

NDA 022345

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	50MG	1	POTIGA	EZOGABINE
002	TABLET;ORAL	200MG	1	POTIGA	EZOGABINE
003	TABLET;ORAL	300MG	1	POTIGA	EZOGABINE
004	TABLET;ORAL	400MG	1	POTIGA	EZOGABINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2011-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2012-11-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2013-09-06	STANDARD
LABELING; Labeling	SUPPL	7	AP	2013-06-06	STANDARD
REMS; REMS	SUPPL	9	AP	2015-11-25	N/A
LABELING; Labeling	SUPPL	10	AP	2015-05-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-05-20	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	4	Null	0
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	6
SUPPL	10	Null	6
SUPPL	11	Null	6

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22345
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM259619.pdf"]
            [products] => [{"drugName":"POTIGA","activeIngredients":"EZOGABINE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"POTIGA","activeIngredients":"EZOGABINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"POTIGA","activeIngredients":"EZOGABINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"POTIGA","activeIngredients":"EZOGABINE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/20\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022345s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022345s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2013","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022345s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022345s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022345s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022345s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2012","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022345s001lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022345s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"POTIGA","submission":"EZOGABINE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"POTIGA","submission":"EZOGABINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"POTIGA","submission":"EZOGABINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"POTIGA","submission":"EZOGABINE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-05-20
        )

)