FDA.reportPublic FDA data

Application 021286

Type
NDA
Sponsor
DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENICAROLMESARTAN MEDOXOMILTABLET;ORAL5MGYesNo
003BENICAROLMESARTAN MEDOXOMILTABLET;ORAL20MGYesNo
004BENICAROLMESARTAN MEDOXOMILTABLET;ORAL40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0860Benicarolmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0860Benicarolmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0861Benicarolmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0861Benicarolmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0862Benicarolmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
0713-0862Benicarolmesartan medoxomilCosette Pharmaceuticals, Inc.NDACurrent
50090-0877Benicarolmesartan medoxomilA-S Medication SolutionsNDACurrent
50090-0877Benicarolmesartan medoxomilA-S Medication SolutionsNDACurrent
51138-211Benicarolmesartan medoxomilMed-Health Pharma, LLCNDACurrent
51138-212Benicarolmesartan medoxomilMed-Health Pharma, LLCNDACurrent
51138-213Benicarolmesartan medoxomilMed-Health Pharma, LLCNDACurrent
55154-6130Benicarolmesartan medoxomilCardinal HealthNDACurrent
55289-436Benicarolmesartan medoxomilPD-Rx Pharmaceuticals, Inc.NDACurrent
57664-755Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-755Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-755Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-755Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-756Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-756Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-756Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-756Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-757Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-757Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
57664-757Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDACurrent
57664-757Olmesartan Medoxomilolmesartan medoxomilSun Pharmaceutical Industries, Inc.NDA AUTHORIZED GENERICCurrent
63629-3390Benicarolmesartan medoxomilBryant Ranch PrepackNDACurrent
65597-101Benicarolmesartan medoxomilDaiichi Sankyo, Inc.NDACurrent
65597-101Benicarolmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-101Benicarolmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-101Benicarolmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-101Benicarolmesartan medoxomilDaiichi Sankyo, Inc.NDACurrent
65597-103Benicarolmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-103Benicarolmesartan medoxomilDaiichi Sankyo, Inc.NDACurrent
65597-103Benicarolmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-103Benicarolmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-103Benicarolmesartan medoxomilDaiichi Sankyo, Inc.NDACurrent
65597-104Benicarolmesartan medoxomilDaiichi Sankyo, Inc.NDACurrent
65597-104Benicarolmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-104Benicarolmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-104Benicarolmesartan medoxomilDaiichi Sankyo Inc.NDACurrent
65597-104Benicarolmesartan medoxomilDaiichi Sankyo, Inc.NDACurrent
68151-4633Benicarolmesartan medoxomilCarilion Materials ManagementNDACurrent
71335-0197Olmesartan Medoxomilolmesartan medoxomilBryant Ranch PrepackNDACurrent
71335-0197Olmesartan Medoxomilolmesartan medoxomilBryant Ranch PrepackNDACurrent
71335-0197Olmesartan Medoxomilolmesartan medoxomilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60587SUPPL2019-10-18
60584SUPPL2019-10-18
45778SUPPL2016-11-02
45773SUPPL2016-11-01
21576SUPPL2015-07-21
36590SUPPL2014-09-26
4926SUPPL2014-09-24
36589SUPPL2014-06-30
27384SUPPL2014-06-30
14890SUPPL2014-06-17
4925SUPPL2014-06-17
27383SUPPL2013-07-05
14889SUPPL2013-07-05
36588SUPPL2012-12-13
27382SUPPL2012-12-11
27381SUPPL2012-10-03
36587SUPPL2012-10-02
4924SUPPL2012-04-02
36586SUPPL2012-03-30
36585SUPPL2012-02-17
27380SUPPL2012-02-17
4923SUPPL2011-06-07
36584SUPPL2011-06-06
4922SUPPL2011-05-24
36583SUPPL2011-05-23
27379SUPPL2010-02-17
14888SUPPL2010-02-16
4921SUPPL2007-10-04
14887SUPPL2005-07-15
4920SUPPL2005-07-15
27378SUPPL2004-11-16
4919SUPPL2003-02-12
27377SUPPL2002-10-25
21575ORIG2002-07-05
14886ORIG2002-04-25
4918ORIG2002-04-25
64056ORIG1900-01-01
64055ORIG1900-01-01
58109ORIG1900-01-01
53355ORIG1900-01-01
53354ORIG1900-01-01
53353ORIG1900-01-01