ezogabine Oral Tablet

Brand(s)
Potiga
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-05-26)
Oldest Current Product
2012-04-19
License(s)
NDA
RxNORM
ORAL TABLET\EZOGABINE
FDAOB
ORAL\TABLET\EZOGABINE
SPL Active
ORAL\TABLET, FILM COATED\EZOGABINE
SPL Moiety
ORAL\TABLET, FILM COATED\EZOGABINE

product(s) by strength(s)

ezogabine 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730812PotigaNDAGlaxosmithkline Llc2012-04-19EZOGABINEORALTABLET, FILM COATEDNDA0223450c60979b-489d-4e7b-8893-468ae00c44bb

ezogabine 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730813PotigaNDAGlaxosmithkline Llc2012-04-19EZOGABINEORALTABLET, FILM COATEDNDA0223450c60979b-489d-4e7b-8893-468ae00c44bb

ezogabine 400 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730814PotigaNDAGlaxosmithkline Llc2012-04-19EZOGABINEORALTABLET, FILM COATEDNDA0223450c60979b-489d-4e7b-8893-468ae00c44bb

ezogabine 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730810PotigaNDAGlaxosmithkline Llc2012-04-19EZOGABINEORALTABLET, FILM COATEDNDA0223450c60979b-489d-4e7b-8893-468ae00c44bb

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA022345POTIGAGLAXOSMITHKLINE2011-06-10NEW CHEMICAL ENTITY [2016-06-10]NDA022345_001, NDA022345_002, NDA022345_003, NDA022345_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022345_001RXEZOGABINE (50MG)ORALTABLETFalse2011-06-10POTIGA
2NDA022345_002RXEZOGABINE (200MG)ORALTABLETFalse2011-06-10POTIGA
3NDA022345_003RXEZOGABINE (300MG)ORALTABLETFalse2011-06-10POTIGA
4NDA022345_004RXEZOGABINE (400MG)ORALTABLETTrue2011-06-10POTIGA

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
10c60979b-489d-4e7b-8893-468ae00c44bb (view SPL)These highlights do not include all the information needed to use POTIGA safely and effectively. See full prescribing information for POTIGA. POTIGA (ezogabine) tablets, for oral use, CVInitial U.S. Approval: 2011prescriptionHuman PrescriptionGlaxosmithkline Llc2014-05-2610001730810, 001730812, 001730813, 001730814

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII