FDA.reportPublic FDA data

Application 020839

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLAVIXCLOPIDOGREL BISULFATETABLET;ORALEQ 75MG BASEYesNo
002PLAVIXCLOPIDOGREL BISULFATETABLET;ORALEQ 300MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-1171Plavixclopidogrelsanofi-aventis U.S. LLCNDACurrent
0024-1171Plavixclopidogrelsanofi-aventis U.S. LLCNDACurrent
0024-1171Plavixclopidogrelsanofi-aventis U.S. LLCNDACurrent
0024-1332Plavixclopidogrelsanofi-aventis U.S. LLCNDACurrent
0024-1332Plavixclopidogrelsanofi-aventis U.S. LLCNDACurrent
0024-1332Plavixclopidogrelsanofi-aventis U.S. LLCNDACurrent
21695-665Plavixclopidogrel bisulfateRebel Distributors CorpNDACurrent
53808-0763Plavixclopidogrel bisulfateState of Florida DOH Central PharmacyNDACurrent
55289-911Plavixclopidogrel bisulfatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-911Plavixclopidogrel bisulfatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-911Plavixclopidogrel bisulfatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-911Plavixclopidogrel bisulfatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-911Plavixclopidogrel bisulfatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-911Plavixclopidogrel bisulfatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-911Plavixclopidogrel bisulfatePD-Rx Pharmaceuticals, Inc.NDACurrent
63653-1171PlavixclopidogrelBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1171PlavixclopidogrelBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1171Plavixclopidogrel bisulfateBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1171Plavixclopidogrel bisulfateBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1171PlavixclopidogrelBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1171Plavixclopidogrel bisulfateBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1171Plavixclopidogrel bisulfateBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1332PlavixclopidogrelBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1332Plavixclopidogrel bisulfateBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1332Plavixclopidogrel bisulfateBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1332PlavixclopidogrelBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1332Plavixclopidogrel bisulfateBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1332Plavixclopidogrel bisulfateBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
63653-1332PlavixclopidogrelBristol-Myers Squibb/Sanofi Pharmaceuticals PartnershipNDACurrent
67046-604Plavixclopidogrel bisulfateContract Pharmacy Services-PANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75409SUPPL 2023-09-14
75410SUPPL 2023-09-13
72115SUPPL2022-09-20
72105SUPPL2022-09-19
66450SUPPL2021-03-02
66438SUPPL2021-03-02
66437SUPPL2021-03-02
58787SUPPL2019-05-20
58786SUPPL2019-05-20
58785SUPPL2019-05-20
55941SUPPL2018-10-15
55899SUPPL2018-10-12
54366SUPPL2018-05-29
54365SUPPL2018-05-29
54356SUPPL2018-05-29
50249SUPPL2017-10-31
48971SUPPL2017-07-13
48966SUPPL2017-07-13
45786SUPPL2016-11-02
45349SUPPL2016-09-21
45348SUPPL2016-09-21
45317SUPPL2016-09-16
45316SUPPL2016-09-16
3546SUPPL2015-07-20
13586SUPPL2015-07-17
13585SUPPL2013-12-17
26025SUPPL2013-12-16
13584SUPPL2013-09-17
3545SUPPL2013-09-13
41755SUPPL2012-03-02
35494SUPPL2011-12-23
3544SUPPL2011-12-22
41756SUPPL2011-07-08
24181SUPPL2011-07-08
3541SUPPL2011-05-10
35492SUPPL2011-05-06
3543SUPPL2011-05-06
3542SUPPL2011-02-07
35493SUPPL2011-02-04
35491SUPPL2010-08-19
3540SUPPL2010-08-16
23605ORIG2010-08-09
26024SUPPL2010-03-18
13583SUPPL2010-03-12
21002ORIG2010-03-04
3539SUPPL2010-01-20
35490SUPPL2009-11-16
26023SUPPL2009-08-26
35489SUPPL2009-05-11
35488SUPPL2007-09-26
3538SUPPL2007-09-25
51480SUPPL2007-08-24
3537SUPPL2007-05-09
35487SUPPL2007-05-07
26021SUPPL2006-08-21
35486SUPPL2006-08-18
21011SUPPL2006-08-17
26022SUPPL2006-08-07
13582SUPPL2006-08-07
13581SUPPL2005-10-19
3536SUPPL2005-10-19
41754SUPPL2005-08-04
41752SUPPL2005-08-04
41751SUPPL2005-08-04
41750SUPPL2005-08-04
41749SUPPL2005-08-04
41748SUPPL2005-08-04
41747SUPPL2005-08-04
41746SUPPL2005-08-04
41745SUPPL2005-08-04
21010SUPPL2005-08-04
21009SUPPL2005-08-04
21008SUPPL2005-08-04
21007SUPPL2005-08-04
21006SUPPL2005-08-04
21005SUPPL2005-08-04
21004SUPPL2005-08-04
21003SUPPL2005-08-04
26020SUPPL2005-04-28
13580SUPPL2005-04-28
13579SUPPL2005-04-28
3535SUPPL2005-04-28
3534SUPPL2005-04-28
3532SUPPL2004-10-15
3533SUPPL2003-10-09
3531SUPPL2003-10-09
41753SUPPL2002-02-27
26019SUPPL2002-02-27
13578SUPPL2002-02-27
3530SUPPL2002-01-28
51479SUPPL2001-10-15
63513SUPPL1900-01-01
54034SUPPL1900-01-01
53221SUPPL1900-01-01
53220SUPPL1900-01-01