FDA.reportPublic FDA data

Application 020758

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;150MGYesYes
003AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;300MGYesYes
004AVALIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazidesanofi-aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5855Avalideirbesartan and hydrochlorothiazidesanofi-aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazidesanofi-aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazidesanofi-aventis U.S. LLCNDACurrent
0024-5856Avalideirbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLCNDACurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideWinthrop U.S.NDA AUTHORIZED GENERICCurrent
71335-1392Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1392Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83043SUPPL 2025-08-05
83034SUPPL 2025-08-04
68611SUPPL2021-09-14
68601SUPPL2021-09-13
67468SUPPL2021-05-12
67458SUPPL2021-05-12
65655SUPPL2020-12-21
65601SUPPL2020-12-16
64432SUPPL2020-08-27
64431SUPPL2020-08-27
64384SUPPL2020-08-24
55141SUPPL2018-08-09
54947SUPPL2018-07-23
48972SUPPL2017-07-13
48965SUPPL2017-07-13
35288SUPPL2016-02-18
25721SUPPL2016-02-09
3279SUPPL2014-06-02
35287SUPPL2014-05-30
3278SUPPL2012-10-29
13355SUPPL2012-10-26
35285SUPPL2012-02-17
25719SUPPL2012-02-13
35286SUPPL2012-01-23
25720SUPPL2012-01-23
25718SUPPL2011-06-09
3277SUPPL2011-06-09
35284SUPPL2011-06-06
35283SUPPL2011-06-06
35282SUPPL2010-09-10
25717SUPPL2010-09-09
20913ORIG2009-09-01
25716SUPPL2007-11-19
13354SUPPL2007-11-19
35281SUPPL2006-04-25
3276SUPPL2006-04-25
25715SUPPL2005-11-30
44463SUPPL2005-05-05
41665SUPPL2005-05-05
44464SUPPL2005-05-03
41666SUPPL2005-05-03
20916SUPPL2005-05-03
41667SUPPL2005-04-27
20917SUPPL2005-04-27
3275SUPPL2005-03-18
20915SUPPL2004-05-27
20914SUPPL1998-08-31