tiagabine Oral Tablet

Brand(s)
Gabitril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cephalon, Incorporated (2015-11-17)
Oldest Current Product
1997-11-03
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\TIAGABINE
FDAOB
ORAL\TABLET\TIAGABINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\TIAGABINE HYDROCHLORIDE
ORAL\TABLET\TIAGABINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\TIAGABINE
ORAL\TABLET\TIAGABINE

product(s) by strength(s)

tiagabine hydrochloride 12 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590412GabitrilNDACephalon, Incorporated2001-04-01TIAGABINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020646cf97a72e-951e-a7db-a574-adac12a6b189

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900832GabitrilNDAStat Rx Usa Llc1997-11-03TIAGABINE HYDROCHLORIDEORALTABLET634590412NDA020646175f2d9f-449b-4d95-a4b9-94f891f8e3ae

tiagabine hydrochloride 16 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590416GabitrilNDACephalon, Incorporated2001-04-01TIAGABINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020646cf97a72e-951e-a7db-a574-adac12a6b189

tiagabine hydrochloride 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590402GabitrilNDACephalon, Incorporated2001-04-01TIAGABINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020646cf97a72e-951e-a7db-a574-adac12a6b189

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1552530600NDA AUTHORIZED GENERICCima Labs Inc.2012-12-21TIAGABINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA02064625225511-70b8-4377-ad4f-6629025ac75f
2627560200ANDASun Pharmaceutical Industries Limited2011-11-04TIAGABINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0775557eeb2d81-c5d7-46a0-aa5c-149b55df71bd

tiagabine hydrochloride 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634590404GabitrilNDACephalon, Incorporated2001-04-01TIAGABINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA020646cf97a72e-951e-a7db-a574-adac12a6b189

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1552530601NDA AUTHORIZED GENERICCima Labs Inc.2012-12-21TIAGABINE HYDROCHLORIDEORALTABLET, FILM COATEDNDA02064625225511-70b8-4377-ad4f-6629025ac75f
2627560224ANDASun Pharmaceutical Industries Limited2011-11-04TIAGABINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0775557eeb2d81-c5d7-46a0-aa5c-149b55df71bd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1499990692GabitrilNDALake Erie Medical Dba Quality Care Products Llc2011-11-15TIAGABINE HYDROCHLORIDEORALTABLET634590404NDA020646915e98e2-3c86-4ab4-a253-2aaf2082854e
2681514235GabitrilNDACarilion Materials Management1997-11-03TIAGABINE HYDROCHLORIDEORALTABLET634590404NDA02064672b7f357-8827-4a8b-b55a-01fbce47ae80

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA077555TIAGABINE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES LTD2011-11-04ANDA077555_001, ANDA077555_002
2NDA020646GABITRILCEPHALON INC1997-09-30p5958951
p5866590
NDA020646_001, NDA020646_002, NDA020646_003, NDA020646_004, NDA020646_005, NDA020646_006, NDA020646_007, NDA020646_008

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077555_001RXTIAGABINE HYDROCHLORIDE (2MG)ORALTABLETFalseAB2011-11-04TIAGABINE HYDROCHLORIDE
2ANDA077555_002RXTIAGABINE HYDROCHLORIDE (4MG)ORALTABLETFalseAB2011-11-04TIAGABINE HYDROCHLORIDE
3NDA020646_001RXTIAGABINE HYDROCHLORIDE (4MG)ORALTABLETTrueAB1997-09-30GABITRIL
4NDA020646_002RXTIAGABINE HYDROCHLORIDE (12MG)ORALTABLETFalse1997-09-30GABITRIL
5NDA020646_003RXTIAGABINE HYDROCHLORIDE (16MG)ORALTABLETFalse1997-09-30GABITRIL
6NDA020646_004discontinuedTIAGABINE HYDROCHLORIDE (20MG)ORALTABLETFalse1997-09-30GABITRIL
7NDA020646_005RXTIAGABINE HYDROCHLORIDE (2MG)ORALTABLETFalseAB1999-04-16GABITRIL
8NDA020646_006discontinuedTIAGABINE HYDROCHLORIDE (6MG)ORALTABLETFalse2005-11-29GABITRIL
9NDA020646_007discontinuedTIAGABINE HYDROCHLORIDE (8MG)ORALTABLETFalse2005-11-29GABITRIL
10NDA020646_008discontinuedTIAGABINE HYDROCHLORIDE (10MG)ORALTABLETFalse2005-11-29GABITRIL

patent(s)

#idexpiration dateapplication(s)
1p5866590 (view patent)2016-04-29NDA020646
2p5958951 (view patent)2017-06-10NDA020646

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1175f2d9f-449b-4d95-a4b9-94f891f8e3ae (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-08-182165900832
225225511-70b8-4377-ad4f-6629025ac75f (view SPL)Tiagabine Hydrochloride TabletsprescriptionHuman PrescriptionCima Labs Inc.2012-12-261552530600, 552530601
372b7f357-8827-4a8b-b55a-01fbce47ae80 (view SPL)GABITRIL (tiagabine hydrochloride) TabletsprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-06-042681514235
47eeb2d81-c5d7-46a0-aa5c-149b55df71bd (view SPL)Tiagabine Hydrochloride TabletsprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-143627560200, 627560224
5915e98e2-3c86-4ab4-a253-2aaf2082854e (view SPL)GABITRIL(tiagabine hydrochloride) TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2011-11-183213499990692
6cf97a72e-951e-a7db-a574-adac12a6b189 (view SPL)GABITRIL (tiagabine hydrochloride) TabletsRx onlyprescriptionHuman PrescriptionCephalon, Incorporated2015-11-1715634590402, 634590404, 634590412, 634590416

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