Application 022345

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTIGAEZOGABINETABLET;ORAL50MGYesNo
002POTIGAEZOGABINETABLET;ORAL200MGYesNo
003POTIGAEZOGABINETABLET;ORAL300MGYesNo
004POTIGAEZOGABINETABLET;ORAL400MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0810POTIGAezogabineGlaxoSmithKline LLCNDACurrent
0173-0812POTIGAezogabineGlaxoSmithKline LLCNDACurrent
0173-0814POTIGAezogabineGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29631SUPPL2016-05-24
17279SUPPL2016-05-23
7274SUPPL2015-11-27
38605SUPPL2015-05-29
29630SUPPL2015-05-28
23709ORIG2013-11-01
29629SUPPL2013-09-11
38604SUPPL2013-09-09
17278SUPPL2013-06-11
7273SUPPL2013-06-07
29628SUPPL2012-03-23
17277SUPPL2012-03-19
44739ORIG2011-07-11
21998ORIG2011-07-11
43853ORIG2011-06-17
17276ORIG2011-06-16
29627ORIG2011-06-15