FDA.reportPublic FDA data

Application 200175

Type
NDA
Sponsor
DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;12.5MG;20MGYesNo
002TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;12.5MG;40MGYesNo
003TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;25MG;40MGYesNo
004TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;12.5MG;40MGYesNo
005TRIBENZORAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;25MG;40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0874Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0874Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0875Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0875Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0876Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0876Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0877Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0877Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0878Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
0713-0878Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideCosette Pharmaceuticals, Inc.NDACurrent
53808-1120Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideDOH CENTRAL PHARMACYNDACurrent
57664-796Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-796Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-796Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-796Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-796Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-796Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-797Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-797Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-797Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-797Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-797Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-797Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-798Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-798Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-798Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-798Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-798Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-798Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-799Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-799Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-799Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-799Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-799Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-799Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-800Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-800Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-800Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-800Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDACurrent
57664-800Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-800Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
65597-114Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-114Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-114Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-114Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-114Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-114Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-114Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-115Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-115Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-115Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-115Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-115Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-115Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-115Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-116Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-116Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-116Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-116Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-116Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-116Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-116Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-117Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-117Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-117Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-117Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-117Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-117Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-117Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-118Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-118Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
65597-118Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-118Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-118Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-118Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo Inc.NDACurrent
65597-118Tribenzorolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideDaiichi Sankyo, Inc.NDACurrent
70518-1648Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideREMEDYREPACK INC.NDACurrent
70518-1648Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideREMEDYREPACK INC.NDACurrent
70518-1648Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideREMEDYREPACK INC.NDACurrent
70518-1648Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazideolmesartan medoxomil, amlodipine besylate and hydrochlorothiazideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64875SUPPL2020-10-07
64823SUPPL2020-10-05
64360SUPPL2020-08-21
64341SUPPL2020-08-21
46835SUPPL2017-01-13
46724SUPPL2017-01-05
45772SUPPL2016-11-02
45769SUPPL2016-11-02
40010SUPPL2014-09-26
32012SUPPL2014-09-24
18951SUPPL2014-07-01
9805SUPPL2014-06-30
9804SUPPL2014-06-18
40009SUPPL2014-06-17
40008SUPPL2013-07-05
32011SUPPL2013-07-05
40007SUPPL2012-12-14
32010SUPPL2012-12-11
9803SUPPL2012-10-03
18950SUPPL2012-10-02
18949SUPPL2012-01-23
9802SUPPL2012-01-23
40006SUPPL2011-11-04
9801SUPPL2011-11-03
43342ORIG2011-07-15
24383ORIG2011-07-15
18948SUPPL2011-06-29
9800SUPPL2011-06-27
18947SUPPL2011-04-11
9799SUPPL2011-04-06
40005ORIG2010-07-30
9798ORIG2010-07-28