FDA.reportPublic FDA data

Application 020905

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARAVALEFLUNOMIDETABLET;ORAL10MGYesNo
002ARAVALEFLUNOMIDETABLET;ORAL20MGYesYes
003ARAVALEFLUNOMIDETABLET;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0088-2160Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2160Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2160Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2160Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2160Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2160Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2160Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2160Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2160Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2161Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2161Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2161Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2161Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2161Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2161Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2161Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2161Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2161Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2162Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2162Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2162Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2162Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2162Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2162Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2162Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2162Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0088-2162Aravaleflunomidesanofi-aventis U.S. LLCNDACurrent
0955-1735LeflunomideleflunomideWinthrop U.S.NDACurrent
0955-1735LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1735LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1735LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1735LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1735LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1735LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1735LeflunomideleflunomideWinthrop U.S.NDACurrent
0955-1737LeflunomideleflunomideWinthrop U.S.NDACurrent
0955-1737LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1737LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1737LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1737LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1737LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1737LeflunomideleflunomideWinthrop U.S.NDACurrent
0955-1737LeflunomideleflunomideWinthrop U.S.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79493SUPPL 2024-11-29
78936SUPPL 2024-07-01
47274SUPPL2017-02-22
45562SUPPL2016-10-20
13723SUPPL2015-09-03
26168SUPPL2015-09-01
3719SUPPL2014-11-18
26167SUPPL2012-11-06
13722SUPPL2012-11-06
35621SUPPL2011-07-12
26166SUPPL2011-07-12
3718SUPPL2010-09-13
13721SUPPL2010-09-10
3717SUPPL2009-04-07
41799SUPPL2008-07-31
21269SUPPL2007-11-19
21268SUPPL2007-11-19
3716SUPPL2007-11-19
13720SUPPL2007-11-13
35620SUPPL2005-10-25
3715SUPPL2005-10-25
35619SUPPL2004-12-03
26165SUPPL2004-12-02
35618SUPPL2004-04-05
26164SUPPL2004-03-10
35617SUPPL2003-06-22
26163SUPPL2003-06-22
13719SUPPL2003-06-22
3714SUPPL2003-06-22
26162ORIG1998-09-10
13718ORIG1998-09-10
63739ORIG1900-01-01
63738ORIG1900-01-01
63737ORIG1900-01-01
63736ORIG1900-01-01
63735ORIG1900-01-01
52886ORIG1900-01-01