FDA.reportPublic FDA data

Application 020757

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVAPROIRBESARTANTABLET;ORAL75MGYesNo
002AVAPROIRBESARTANTABLET;ORAL150MGYesNo
003AVAPROIRBESARTANTABLET;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5850AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5850AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5850AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5850AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5850AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5850AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5850AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5850AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5850Avaproirbesartansanofi-aventis U.S. LLCNDACurrent
0024-5851AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5851AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5851AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5851AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5851AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5851Avaproirbesartansanofi-aventis U.S. LLCNDACurrent
0024-5851AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5851AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5851AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5852AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5852AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5852AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5852AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5852AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5852AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5852AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5852AvaproirbesartanSanofi-Aventis U.S. LLCNDACurrent
0024-5852Avaproirbesartansanofi-aventis U.S. LLCNDACurrent
0955-1040IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1040IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1040IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1040IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1040IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1040IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1040IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1040IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1041IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1041IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1041IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1041IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1041IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1041IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1041IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1041IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1042IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1042IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1042IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1042IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1042IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1042IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1042IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1042IrbesartanirbesartanWinthrop U.S.NDA AUTHORIZED GENERICCurrent
35356-854AvaproirbesartanLake Erie Medical DBA Quality Care Products LLCNDACurrent
50090-5055IrbesartanirbesartanA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5055IrbesartanirbesartanA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5055IrbesartanirbesartanA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
71205-404IrbesartanirbesartanProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-404IrbesartanirbesartanProficient Rx LPNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83042SUPPL 2025-08-05
83033SUPPL 2025-08-04
68610SUPPL2021-09-14
68598SUPPL2021-09-13
67465SUPPL2021-05-12
67457SUPPL2021-05-12
65651SUPPL2020-12-21
65600SUPPL2020-12-16
55140SUPPL2018-08-09
54946SUPPL2018-07-23
35280SUPPL2016-03-04
35277SUPPL2016-03-04
25714SUPPL2016-02-09
25711SUPPL2016-02-09
25713SUPPL2014-06-02
35279SUPPL2014-05-30
35278SUPPL2012-09-14
25712SUPPL2012-09-14
13353SUPPL2012-01-23
3274SUPPL2012-01-23
44069ORIG2011-12-22
3273SUPPL2011-12-14
13352SUPPL2011-12-13
25710SUPPL2011-08-02
35276SUPPL2011-08-01
41664SUPPL2011-02-15
41646ORIG2009-09-01
13351SUPPL2006-04-25
3272SUPPL2006-04-25
25709SUPPL2006-03-23
35275SUPPL2006-03-22
25708SUPPL2005-11-30
41661SUPPL2005-07-29
41660SUPPL2005-07-29
23983SUPPL2005-07-29
23982SUPPL2005-07-29
23981SUPPL2005-07-29
20910SUPPL2005-07-29
44462SUPPL2005-05-05
44461SUPPL2005-05-05
41659SUPPL2005-05-05
20909SUPPL2005-05-05
41663SUPPL2005-05-03
41662SUPPL2005-05-03
20912SUPPL2005-05-03
20911SUPPL2005-05-03
41658SUPPL2005-04-27
41656SUPPL2005-04-27
41653SUPPL2005-04-27
41652SUPPL2005-04-27
41651SUPPL2005-04-27
41650SUPPL2005-04-27
41649SUPPL2005-04-27
41648SUPPL2005-04-27
41647SUPPL2005-04-27
23980SUPPL2005-04-27
20908SUPPL2005-04-27
20907SUPPL2005-04-27
20906SUPPL2005-04-27
20904SUPPL2005-04-27
20903SUPPL2005-04-27
20902SUPPL2005-04-27
41657SUPPL2004-05-27
41655SUPPL2004-05-27
41654SUPPL2004-05-27
20905SUPPL2004-05-27
3270SUPPL2002-09-20
35274SUPPL2002-09-17
3271SUPPL2002-07-19
53102ORIG1900-01-01
53101ORIG1900-01-01
53100ORIG1900-01-01
53099ORIG1900-01-01