FDA.reportPublic FDA data

Application 021532

Type
NDA
Sponsor
DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002BENICAR HCTHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORAL12.5MG;20MGYesNo
003BENICAR HCTHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORAL12.5MG;40MGYesNo
005BENICAR HCTHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORAL25MG;40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0863Benicar HCTolmesartan medoxomil-hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0863Benicar HCTolmesartan medoxomil-hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0864Benicar HCTolmesartan medoxomil-hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0864Benicar HCTolmesartan medoxomil-hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0865Benicar HCTolmesartan medoxomil-hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0865Benicar HCTolmesartan medoxomil-hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
50090-1083Benicar HCTolmesartan medoxomil-hydrochlorothiazideA-S Medication SolutionsNDACurrent
50090-1083Benicar HCTolmesartan medoxomil-hydrochlorothiazideA-S Medication SolutionsNDACurrent
50090-4329Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideA-S Medication SolutionsNDACurrent
55289-443Benicar HCTolmesartan medoxomil-hydrochlorothiazidePD-Rx Pharmaceuticals, Inc.NDACurrent
57664-758Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-758Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-758Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-758Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-758Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-759Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-759Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-759Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-759Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-759Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-760Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-760Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-760Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-760Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-760Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
65597-105Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-105Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-105Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-105Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-105Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-105Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-105Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-106Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-106Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-106Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-106Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-106Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-106Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-106Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-107Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-107Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-107Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-107Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-107Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-107Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-107Benicar HCTolmesartan medoxomil-hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
71335-0203Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideBryant Ranch PrepackNDACurrent
71335-0203Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideBryant Ranch PrepackNDACurrent
71335-0203Olmesartan Medoxomil and Hydrochlorothiazideolmesartan medoxomil-hydrochlorothiazideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81997SUPPL 2025-04-25
81929SUPPL 2025-04-16
64437SUPPL2020-08-27
64357SUPPL2020-08-21
37173SUPPL2016-02-18
28044SUPPL2016-02-12
15709SUPPL2014-09-26
5667SUPPL2014-09-24
15708SUPPL2014-06-30
5666SUPPL2014-06-30
28046SUPPL2014-06-17
15707SUPPL2014-06-17
37175SUPPL2013-07-05
5665SUPPL2013-07-05
15706SUPPL2012-12-14
5664SUPPL2012-12-11
28045SUPPL2012-09-24
15705SUPPL2012-09-20
37174SUPPL2012-01-30
5663SUPPL2012-01-20
15704SUPPL2011-05-05
15703SUPPL2011-05-05
5662SUPPL2011-05-05
5661SUPPL2011-05-05
5660SUPPL2007-11-19
37172SUPPL2005-07-15
28043SUPPL2005-07-15
5659SUPPL2004-11-16
21720ORIG2003-09-10
37171ORIG2003-06-08
28042ORIG2003-06-08