FDA.reportPublic FDA data

Application 022100

Type
NDA
Sponsor
DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZORAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;20MGYesNo
002AZORAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;40MGYesNo
003AZORAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;20MGYesNo
004AZORAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0870Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0870Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0870Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0871Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0871Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0871Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0872Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0872Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0872Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0873Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0873Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0873Azoramlodipine besylate and olmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
57664-772Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-772Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-772Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-772Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-772Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-773Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-773Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-773Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-773Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-773Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-774Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-774Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-774Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-774Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-774Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-775Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-775Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-775Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-775Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-775Amlodipine and Olmesartan Medoxomilamlodipine besylate and olmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
65597-110Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-110Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-110Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-110Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-110Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-110Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-111Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-111Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-111Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-111Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-111Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-111Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-112Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-112Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-112Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-112Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-112Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-112Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-113Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-113Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-113Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-113Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-113Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-113Azoramlodipine besylate and olmesartan medoxomilDaiichi Sankyo Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64874SUPPL2020-10-07
64819SUPPL2020-10-05
46836SUPPL2017-01-13
46723SUPPL2017-01-06
46132SUPPL2016-12-13
45779SUPPL2016-11-02
45775SUPPL2016-11-01
16929SUPPL2014-09-26
6875SUPPL2014-09-24
38230SUPPL2014-07-03
6874SUPPL2014-07-03
6873SUPPL2014-06-18
38229SUPPL2014-06-17
38228SUPPL2013-07-05
6872SUPPL2013-07-05
38227SUPPL2012-12-13
6871SUPPL2012-12-11
29235SUPPL2012-10-03
16928SUPPL2012-10-02
38226SUPPL2012-01-23
29234SUPPL2012-01-20
29232SUPPL2011-11-16
38224SUPPL2011-11-14
29233SUPPL2011-11-03
38225SUPPL2011-10-31
6870SUPPL2011-05-24
6869SUPPL2011-05-24
38223SUPPL2011-05-23
16927SUPPL2011-05-23
21935ORIG2009-12-17
29230SUPPL2009-05-14
38222SUPPL2009-05-13
29231SUPPL2008-08-12
38221ORIG2007-10-04
6868ORIG2007-10-04