leflunomide Oral Tablet

Brand(s)
Arava
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-08-01)
Oldest Current Product
1998-09-10
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\LEFLUNOMIDE
FDAOB
ORAL\TABLET\LEFLUNOMIDE
SPL Active
ORAL\TABLET, FILM COATED\LEFLUNOMIDE
ORAL\TABLET\LEFLUNOMIDE
SPL Moiety
ORAL\TABLET, FILM COATED\LEFLUNOMIDE
ORAL\TABLET\LEFLUNOMIDE

product(s) by strength(s)

leflunomide 10 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009551735NDAWinthrop U.S.2015-09-07LEFLUNOMIDEORALTABLET, FILM COATEDNDA020905eb85de02-2964-453b-978a-26451cd1c97a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1138110677ANDATrigen Laboratories, Inc.2011-05-06LEFLUNOMIDEORALTABLETANDA091369332aeb48-8a1a-4d50-be12-05411b7a2967
2167140321ANDANorthstar Rx Llc2011-05-06LEFLUNOMIDEORALTABLETANDA091369b933c448-a7e5-4f38-b5e2-a03615826fa3
3231550043ANDAHeritage Pharmaceuticals Inc.2009-10-29LEFLUNOMIDEORALTABLETANDA07708640dd071a-d07f-452f-bf1a-2a23b9d22ca4
4605052502ANDAApotex Corp2005-09-13LEFLUNOMIDEORALTABLETANDA077090753453c5-8a7a-878e-3ce7-1d1edce718a9
5669930160NDA AUTHORIZED GENERICPrasco Laboratories1998-09-10LEFLUNOMIDEORALTABLET, FILM COATEDNDA0209052dba6c8e-3c51-4762-ae27-dcd760783f9b

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686170ANDAPhysicians Total Care, Inc.2010-09-17LEFLUNOMIDEORALTABLET, FILM COATED007815056ANDA07708714d06124-1eef-4f97-b1f3-18620819ae1a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290319ANDAGolden State Medical Supply, Inc.2005-09-13LEFLUNOMIDEORALTABLET605052502ANDA077090504d0066-a070-41b0-95b7-09994e4ff03e

leflunomide 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000882162AravaNDASanofi-Aventis U.S. Llc1998-09-19LEFLUNOMIDEORALTABLET, FILM COATEDNDA020905320f63f2-fac3-4aee-aff8-85724e00ef52

leflunomide 20 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009551737NDAWinthrop U.S.2015-09-07LEFLUNOMIDEORALTABLET, FILM COATEDNDA020905eb85de02-2964-453b-978a-26451cd1c97a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1138110678ANDATrigen Laboratories, Inc.2011-05-06LEFLUNOMIDEORALTABLETANDA091369332aeb48-8a1a-4d50-be12-05411b7a2967
2167140331ANDANorthstar Rx Llc2011-05-06LEFLUNOMIDEORALTABLETANDA091369b933c448-a7e5-4f38-b5e2-a03615826fa3
3231550044ANDAHeritage Pharmaceuticals Inc.2009-10-29LEFLUNOMIDEORALTABLETANDA07708640dd071a-d07f-452f-bf1a-2a23b9d22ca4
4605052503ANDAApotex Corp2005-09-13LEFLUNOMIDEORALTABLETANDA077090753453c5-8a7a-878e-3ce7-1d1edce718a9
5669930161NDA AUTHORIZED GENERICPrasco Laboratories1998-09-10LEFLUNOMIDEORALTABLET, FILM COATEDNDA0209052dba6c8e-3c51-4762-ae27-dcd760783f9b

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682319ANDAPhysicians Total Care, Inc.2006-07-10LEFLUNOMIDEORALTABLET, FILM COATED007815057ANDA07708714d06124-1eef-4f97-b1f3-18620819ae1a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290320ANDAGolden State Medical Supply, Inc.2005-09-13LEFLUNOMIDEORALTABLET605052503ANDA077090504d0066-a070-41b0-95b7-09994e4ff03e
2636291263AravaNDABryant Ranch Prepack1998-09-10LEFLUNOMIDEORALTABLET, FILM COATED000882161NDA0209059e149fbe-0067-4700-9a75-96b21f78b199
3682582992ANDADispensing Solutions, Inc.2009-10-29LEFLUNOMIDEORALTABLET231550044ANDA0770862fcef74c-2df9-4b16-b2f6-82c25957a680
4691890334ANDAAvera Mckennan Hospital2015-03-01LEFLUNOMIDEORALTABLET167140331ANDA0913691e50897c-43a0-4934-bba4-75e8165fb3d1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077083LEFLUNOMIDEBARR LABORATORIES INC2005-09-13ANDA077083_001, ANDA077083_002
2ANDA077084LEFLUNOMIDETEVA PHARMACEUTICALS USA2005-09-13ANDA077084_001, ANDA077084_002
3ANDA077085LEFLUNOMIDETrueSANDOZ INC2005-09-13ANDA077085_001, ANDA077085_002
4ANDA077086LEFLUNOMIDEHERITAGE PHARMACEUTICALS INC2005-09-13ANDA077086_001, ANDA077086_002
5ANDA077087LEFLUNOMIDETrueSANDOZ INC2005-09-13ANDA077087_001, ANDA077087_002
6ANDA077090LEFLUNOMIDEAPOTEX INC ETOBICOKE SITE2005-09-13ANDA077090_001, ANDA077090_002
7ANDA091369LEFLUNOMIDEALEMBIC PHARMACEUTICALS LTD2011-11-21ANDA091369_001, ANDA091369_002
8NDA020905ARAVASANOFI AVENTIS US LLC1998-09-10NDA020905_001, NDA020905_002, NDA020905_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077083_001RXLEFLUNOMIDE (10MG)ORALTABLETFalseAB2005-09-13LEFLUNOMIDE
2ANDA077083_002RXLEFLUNOMIDE (20MG)ORALTABLETFalseAB2005-09-13LEFLUNOMIDE
3ANDA077084_001RXLEFLUNOMIDE (10MG)ORALTABLETFalseAB2005-09-13LEFLUNOMIDE
4ANDA077084_002RXLEFLUNOMIDE (20MG)ORALTABLETFalseAB2005-09-13LEFLUNOMIDE
5ANDA077085_001discontinuedLEFLUNOMIDE (10MG)ORALTABLETFalse2005-09-13LEFLUNOMIDE
6ANDA077085_002discontinuedLEFLUNOMIDE (20MG)ORALTABLETFalse2005-09-13LEFLUNOMIDE
7ANDA077086_001RXLEFLUNOMIDE (10MG)ORALTABLETFalseAB2005-09-13LEFLUNOMIDE
8ANDA077086_002RXLEFLUNOMIDE (20MG)ORALTABLETFalseAB2005-09-13LEFLUNOMIDE
9ANDA077087_001discontinuedLEFLUNOMIDE (10MG)ORALTABLETFalse2005-09-13LEFLUNOMIDE
10ANDA077087_002discontinuedLEFLUNOMIDE (20MG)ORALTABLETFalse2005-09-13LEFLUNOMIDE
11ANDA077090_001RXLEFLUNOMIDE (10MG)ORALTABLETFalseAB2005-09-13LEFLUNOMIDE
12ANDA077090_002RXLEFLUNOMIDE (20MG)ORALTABLETFalseAB2005-09-13LEFLUNOMIDE
13ANDA091369_001RXLEFLUNOMIDE (10MG)ORALTABLETFalseAB2011-11-21LEFLUNOMIDE
14ANDA091369_002RXLEFLUNOMIDE (20MG)ORALTABLETFalseAB2011-11-21LEFLUNOMIDE
15NDA020905_001RXLEFLUNOMIDE (10MG)ORALTABLETFalseAB1998-09-10ARAVA
16NDA020905_002RXLEFLUNOMIDE (20MG)ORALTABLETTrueAB1998-09-10ARAVA
17NDA020905_003RXLEFLUNOMIDE (100MG)ORALTABLETTrue1998-09-10ARAVA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
114d06124-1eef-4f97-b1f3-18620819ae1a (view SPL)Leflunomide Tablets10 mg and 20 mgprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-06-261548682319, 548686170
21e50897c-43a0-4934-bba4-75e8165fb3d1 (view SPL)These highlights do not include all the information needed to use leflunomide tablets safely and effectively. See full prescribing information for leflunomide tablets. LEFLUNOMIDE tablets USP, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-021691890334
32dba6c8e-3c51-4762-ae27-dcd760783f9b (view SPL)Leflunomide Tablets10 mg, 20 mgprescriptionHuman PrescriptionPrasco LaboratoriesMANUFACTURE2012-08-317669930160, 669930161
42fcef74c-2df9-4b16-b2f6-82c25957a680 (view SPL)LEFLUNOMIDE TABLETS, USP 10 MG AND 20 MG Rx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-10-171682582992
5320f63f2-fac3-4aee-aff8-85724e00ef52 (view SPL)These highlights do not include all the information needed to use ARAVA safely and effectively. See full prescribing information for ARAVA. ARAVA (leflunomide), tablets, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcMANUFACTURE2015-08-0112000882162, 000882160, 000882161
6332aeb48-8a1a-4d50-be12-05411b7a2967 (view SPL)These highlights do not include all the information needed to use leflunomide tablets safely and effectively. See full prescribing information for leflunomide tablets. LEFLUNOMIDE tablets USP, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionTrigen Laboratories, Inc.MANUFACTURE2015-10-072138110677, 138110678
740dd071a-d07f-452f-bf1a-2a23b9d22ca4 (view SPL)LEFLUNOMIDE TABLETS, USP 10 MG AND 20 MG Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2014-03-066231550043, 231550044
8504d0066-a070-41b0-95b7-09994e4ff03e (view SPL)Leflunomide Tablets, 10 mg and 20 mgprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290319, 604290320
9753453c5-8a7a-878e-3ce7-1d1edce718a9 (view SPL)These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS, USP safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS, USP. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionApotex Corp2015-09-304605052502, 605052503
109e149fbe-0067-4700-9a75-96b21f78b199 (view SPL)ARAVA Tablets (leflunomide) 10 mg, 20 mg, 100 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636291263
11b933c448-a7e5-4f38-b5e2-a03615826fa3 (view SPL)These highlights do not include all the information needed to use leflunomide tablets safely and effectively. See full prescribing information for leflunomide tablets. LEFLUNOMIDE tablets USP, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionNorthstar Rx LlcMANUFACTURE2015-10-149167140321, 167140331
12eb85de02-2964-453b-978a-26451cd1c97a (view SPL)Leflunomide Tablets 10 mg, 20 mgprescriptionHuman PrescriptionWinthrop U.S.ANALYSIS, LABEL, MANUFACTURE, PACK2015-08-201009551735, 009551737

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