DAIICHI SANKYO FDA Approval NDA 021286

NDA 021286

DAIICHI SANKYO

FDA Drug Application

Application #021286

Documents

Letter2002-04-25
Letter2003-02-12
Letter2005-07-15
Letter2007-10-04
Letter2011-05-24
Letter2011-06-07
Letter2012-04-02
Letter2014-06-17
Letter2014-09-24
Label2002-04-25
Label2005-07-15
Label2010-02-16
Label2013-07-05
Label2014-06-17
Review2002-07-05
Review2015-07-21
Letter2002-10-25
Letter2004-11-16
Letter2010-02-17
Letter2012-02-17
Letter2012-10-03
Letter2012-12-11
Letter2013-07-05
Letter2014-06-30
Label2011-05-23
Label2011-06-06
Label2012-02-17
Label2012-03-30
Label2012-10-02
Label2012-12-13
Label2014-06-30
Label2014-09-26
Label2016-11-01
Letter2016-11-02
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Written Request1900-01-01
Label2019-10-18
Letter2019-10-18
Pediatric Amendment 11900-01-01
Pediatric Written Request1900-01-01

Application Sponsors

NDA 021286DAIICHI SANKYO

Marketing Status

Prescription001
Prescription003
Prescription004

Application Products

001TABLET;ORAL5MG1BENICAROLMESARTAN MEDOXOMIL
003TABLET;ORAL20MG1BENICAROLMESARTAN MEDOXOMIL
004TABLET;ORAL40MG1BENICAROLMESARTAN MEDOXOMIL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2002-04-25STANDARD
LABELING; LabelingSUPPL2AP2003-02-12STANDARD
LABELING; LabelingSUPPL6AP2004-11-12STANDARD
LABELING; LabelingSUPPL10AP2005-07-13STANDARD
LABELING; LabelingSUPPL12AP2007-09-26STANDARD
EFFICACY; EfficacySUPPL18AP2010-02-04PRIORITY
LABELING; LabelingSUPPL19AP2011-05-19UNKNOWN
LABELING; LabelingSUPPL20AP2011-06-06UNKNOWN
LABELING; LabelingSUPPL21AP2012-02-15UNKNOWN
LABELING; LabelingSUPPL23AP2012-03-29UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2013-02-01STANDARD
LABELING; LabelingSUPPL25AP2012-09-28UNKNOWN
LABELING; LabelingSUPPL26AP2012-12-11STANDARD
LABELING; LabelingSUPPL27AP2013-07-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2014-10-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2014-07-03STANDARD
LABELING; LabelingSUPPL30AP2014-06-13STANDARD
LABELING; LabelingSUPPL31AP2014-06-27STANDARD
LABELING; LabelingSUPPL32AP2014-09-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL34AP2016-06-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2016-07-08STANDARD
LABELING; LabelingSUPPL36AP2016-11-01STANDARD
LABELING; LabelingSUPPL40AP2019-10-17STANDARD

Submissions Property Types

SUPPL18Null7
SUPPL19Null7
SUPPL20Null31
SUPPL21Null6
SUPPL23Null15
SUPPL24Null0
SUPPL25Null6
SUPPL26Null6
SUPPL27Null7
SUPPL28Null0
SUPPL29Null0
SUPPL30Null15
SUPPL31Null6
SUPPL32Null7
SUPPL34Null0
SUPPL35Null0
SUPPL36Null15
SUPPL40Null6

TE Codes

001PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

DAIICHI SANKYO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21286
            [companyName] => DAIICHI SANKYO
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENICAR","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BENICAR","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BENICAR","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/17\/2019","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021286s040lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2016","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021286s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2014","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021286s032lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2014","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021286s031lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2014","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021286s030lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2013","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021286s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021286s026lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021286s025lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2012","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021286s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2012","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021286s021lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2011","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021286s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2011","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021286s019lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2010","submission":"SUPPL-18","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021286s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2005","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021286s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21286lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BENICAR","submission":"OLMESARTAN MEDOXOMIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BENICAR","submission":"OLMESARTAN MEDOXOMIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BENICAR","submission":"OLMESARTAN MEDOXOMIL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-17
        )

)
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