Vigabatrin Oral Solution

Brand(s)
Sabril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lundbeck Inc. (2015-11-05)
Oldest Current Product
2009-08-21
License(s)
NDA
RxNORM
ORAL SOLUTION\VIGABATRIN
FDAOB
ORAL\FOR SOLUTION\VIGABATRIN
SPL Active
ORAL\POWDER, FOR SOLUTION\VIGABATRIN
SPL Moiety
ORAL\POWDER, FOR SOLUTION\VIGABATRIN

product(s) by strength(s)

vigabatrin 50 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1673860211SabrilNDALundbeck Inc.2009-08-21VIGABATRINORALPOWDER, FOR SOLUTIONNDA022006a88ac1b4-e2c9-45c0-b321-4785902172e3

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA022006SABRILLUNDBECK LLC2009-08-21NEW PATIENT POPULATION [2016-10-26]
ORPHAN DRUG EXCLUSIVITY [2016-08-21]
NEW CHEMICAL ENTITY [2014-08-21]
PEDIATRIC EXCLUSIVITY [2015-02-21]
PEDIATRIC EXCLUSIVITY [2017-02-21]
PEDIATRIC EXCLUSIVITY [2017-04-26]
NDA022006_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022006_001RXVIGABATRIN (500MG/PACKET)ORALFOR SOLUTIONTrue2009-08-21SABRIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a88ac1b4-e2c9-45c0-b321-4785902172e3 (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, MANUFACTURE2015-11-0514673860211

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