Vigabatrin Oral Tablet

Brand(s)
Sabril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lundbeck Inc. (2015-09-30)
Oldest Current Product
2009-08-21
License(s)
NDA
RxNORM
ORAL TABLET\VIGABATRIN
FDAOB
ORAL\TABLET\VIGABATRIN
SPL Active
ORAL\TABLET, FILM COATED\VIGABATRIN
SPL Moiety
ORAL\TABLET, FILM COATED\VIGABATRIN

product(s) by strength(s)

vigabatrin 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1673860111SabrilNDALundbeck Inc.2009-08-21VIGABATRINORALTABLET, FILM COATEDNDA020427a5d389d2-d0e1-4395-a2a2-b552808e7f98

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA020427SABRILLUNDBECK LLC2009-08-21NEW CHEMICAL ENTITY [2014-08-21]
NEW PATIENT POPULATION [2016-10-26]
PEDIATRIC EXCLUSIVITY [2015-02-21]
PEDIATRIC EXCLUSIVITY [2017-04-26]
NDA020427_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020427_001RXVIGABATRIN (500MG)ORALTABLETTrue2009-08-21SABRIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a5d389d2-d0e1-4395-a2a2-b552808e7f98 (view SPL)These highlights do not include all the information needed to use SABRIL safely and effectively. See full prescribing information for SABRIL . SABRIL ( vigabatrin ) t ablet s , for oral use SABRIL ( vigabatrin ) powder for o ral s olution Initial U.S. Approval: 2009prescriptionHuman PrescriptionLundbeck Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-09-3011673860111

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