rosiglitazone Oral Tablet

Brand(s)
Avandia
Category(s)
prescription
SPL Type(s)
Human Prescription, Human Prescription with Highlights
Master SPL
Glaxosmithkline Llc (2014-05-07)
Oldest Current Product
1999-05-28
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ROSIGLITAZONE
FDAOB
ORAL\TABLET\ROSIGLITAZONE MALEATE
SPL Active
ORAL\TABLET, FILM COATED\ROSIGLITAZONE MALEATE
ORAL\TABLET\ROSIGLITAZONE MALEATE
SPL Moiety
ORAL\TABLET, FILM COATED\ROSIGLITAZONE
ORAL\TABLET\ROSIGLITAZONE

product(s) by strength(s)

rosiglitazone 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001730834AvandiaNDAGlaxosmithkline Llc2011-05-252016-06-18ROSIGLITAZONE MALEATEORALTABLET, FILM COATEDNDA021071ec682aec-e98f-41a1-9d21-eb7580ea3a8a

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439973ANDAWest-Ward Pharmaceutical Corp2009-06-22ROSIGLITAZONE MALEATEORALTABLETANDA078658dd8d7ec8-79b0-4152-8789-d247c77232ce

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685249AvandiaNDAPhysicians Total Care, Inc.2005-05-13ROSIGLITAZONE MALEATEORALTABLET, FILM COATED000293158NDA021071ef14122b-7fff-45fa-b13b-0ea9e48bd57d

rosiglitazone 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001730835AvandiaNDAGlaxosmithkline Llc2011-05-252015-08-29ROSIGLITAZONE MALEATEORALTABLET, FILM COATEDNDA021071ec682aec-e98f-41a1-9d21-eb7580ea3a8a

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439974ANDAWest-Ward Pharmaceutical Corp2009-06-22ROSIGLITAZONE MALEATEORALTABLETANDA078658dd8d7ec8-79b0-4152-8789-d247c77232ce

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684198AvandiaNDAPhysicians Total Care, Inc.2006-02-07ROSIGLITAZONE MALEATEORALTABLET, FILM COATED000293159NDA021071ef14122b-7fff-45fa-b13b-0ea9e48bd57d
2551544513AvandiaNDACardinal Health1999-05-29ROSIGLITAZONE MALEATEORALTABLET, FILM COATED000293159NDA02107128c31e58-0b27-43e2-bae0-9bbb21420e9f

rosiglitazone 8 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730864AvandiaNDAGlaxosmithkline Llc2011-05-25ROSIGLITAZONE MALEATEORALTABLET, FILM COATEDNDA021071ec682aec-e98f-41a1-9d21-eb7580ea3a8a

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439975ANDAWest-Ward Pharmaceutical Corp2009-06-22ROSIGLITAZONE MALEATEORALTABLETANDA078658dd8d7ec8-79b0-4152-8789-d247c77232ce

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684221AvandiaNDAPhysicians Total Care, Inc.2001-05-09ROSIGLITAZONE MALEATEORALTABLET, FILM COATED000293160NDA021071ef14122b-7fff-45fa-b13b-0ea9e48bd57d
2551544518AvandiaNDACardinal Health1999-05-28ROSIGLITAZONE MALEATEORALTABLET, FILM COATED000293160NDA02107128c31e58-0b27-43e2-bae0-9bbb21420e9f

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076747ROSIGLITAZONE MALEATETEVA PHARMACEUTICALS USA INC2013-01-25ANDA076747_001, ANDA076747_002, ANDA076747_003
2NDA021071AVANDIASB PHARMCO PUERTO RICO INC1999-05-25p7358366
p6288095, METHOD OF TREATMENT OF TYPE II DIABETES
NDA021071_002, NDA021071_003, NDA021071_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076747_001RXROSIGLITAZONE MALEATE (EQ 2MG BASE)ORALTABLETFalseAB2013-01-25ROSIGLITAZONE MALEATE
2ANDA076747_002RXROSIGLITAZONE MALEATE (EQ 4MG BASE)ORALTABLETFalseAB2013-01-25ROSIGLITAZONE MALEATE
3ANDA076747_003RXROSIGLITAZONE MALEATE (EQ 8MG BASE)ORALTABLETFalseAB2013-01-25ROSIGLITAZONE MALEATE
4NDA021071_002RXROSIGLITAZONE MALEATE (EQ 2MG BASE)ORALTABLETFalseAB1999-05-25AVANDIA
5NDA021071_003RXROSIGLITAZONE MALEATE (EQ 4MG BASE)ORALTABLETFalseAB1999-05-25AVANDIA
6NDA021071_004RXROSIGLITAZONE MALEATE (EQ 8MG BASE)ORALTABLETTrueAB1999-05-25AVANDIA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6288095 (view patent)2017-02-11NDA021071, NDA021410Metformin / rosiglitazone Oral Tablet
2p7358366 (view patent)2020-04-19NDA021071, NDA021410, NDA021700Metformin / rosiglitazone Oral Tablet
glimepiride / rosiglitazone Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
128c31e58-0b27-43e2-bae0-9bbb21420e9f (view SPL)These highlights do not include all the information needed to use AVANDIA safely and effectively. See full prescribing information for AVANDIA.AVANDIA (rosiglitazone maleate) TabletsInitial U.S. Approval: 1999prescriptionHuman PrescriptionCardinal HealthREPACK2011-10-032551544513, 551544518
2dd8d7ec8-79b0-4152-8789-d247c77232ce (view SPL)These highlights do not include all the information needed to use rosiglitazone maleate tablets safely and effectively. See full prescribing information for rosiglitazone maleate tablets. Rosiglitazone Maleate Tablets Initial U.S. Approval: 1999prescriptionHuman Prescription with HighlightsWest-Ward Pharmaceutical Corp2009-07-222001439973, 001439974, 001439975
3ec682aec-e98f-41a1-9d21-eb7580ea3a8a (view SPL)These highlights do not include all the information needed to use AVANDIA safely and effectively. See full prescribing information for AVANDIA.AVANDIA (rosiglitazone maleate) tabletsInitial U.S. Approval: 1999prescriptionHuman PrescriptionGlaxosmithkline Llc2014-05-078001730834, 001730835, 001730864, 001730836, 001730861, 001730863
4ef14122b-7fff-45fa-b13b-0ea9e48bd57d (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-191548684198, 548684221, 548685249

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