DAIICHI SANKYO FDA Approval NDA 021532

NDA 021532

DAIICHI SANKYO

FDA Drug Application

Application #021532

Documents

Letter2004-11-16
Letter2007-11-19
Letter2011-05-05
Letter2011-05-05
Letter2012-01-20
Letter2012-12-11
Letter2013-07-05
Letter2014-06-30
Letter2014-09-24
Label2011-05-05
Label2011-05-05
Label2012-09-20
Label2012-12-14
Label2014-06-17
Label2014-06-30
Label2014-09-26
Review2003-09-10
Letter2003-06-08
Letter2005-07-15
Letter2016-02-12
Letter2012-09-24
Letter2014-06-17
Label2003-06-08
Label2005-07-15
Label2016-02-18
Label2012-01-30
Label2013-07-05
Letter2020-08-21
Label2020-08-27

Application Sponsors

NDA 021532DAIICHI SANKYO

Marketing Status

Prescription002
Prescription003
Prescription005

Application Products

002TABLET;ORAL12.5MG;20MG1BENICAR HCTHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
003TABLET;ORAL12.5MG;40MG1BENICAR HCTHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
005TABLET;ORAL25MG;40MG1BENICAR HCTHYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2003-06-05STANDARD
LABELING; LabelingSUPPL4AP2005-07-13STANDARD
LABELING; LabelingSUPPL8AP2007-11-16STANDARD
LABELING; LabelingSUPPL13AP2011-05-03UNKNOWN
LABELING; LabelingSUPPL14AP2011-05-03UNKNOWN
LABELING; LabelingSUPPL15AP2016-02-11STANDARD
LABELING; LabelingSUPPL16AP2012-01-18UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2013-02-01STANDARD
LABELING; LabelingSUPPL20AP2012-09-18UNKNOWN
LABELING; LabelingSUPPL21AP2012-12-11STANDARD
LABELING; LabelingSUPPL22AP2013-07-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2014-05-07STANDARD
LABELING; LabelingSUPPL24AP2014-06-13STANDARD
LABELING; LabelingSUPPL25AP2014-06-27STANDARD
LABELING; LabelingSUPPL26AP2014-09-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2016-05-13STANDARD
LABELING; LabelingSUPPL37AP2020-08-20STANDARD

Submissions Property Types

SUPPL13Null7
SUPPL14Null7
SUPPL15Null15
SUPPL16Null15
SUPPL19Null0
SUPPL20Null15
SUPPL21Null6
SUPPL22Null6
SUPPL23Null0
SUPPL24Null15
SUPPL25Null6
SUPPL26Null7
SUPPL28Null0
SUPPL37Null7

TE Codes

002PrescriptionAB
003PrescriptionAB
005PrescriptionAB

CDER Filings

DAIICHI SANKYO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21532
            [companyName] => DAIICHI SANKYO
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENICAR HCT","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"12.5MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BENICAR HCT","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"12.5MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BENICAR HCT","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"25MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021532s037lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2016","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021532s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021532s026lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2014","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021532s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2014","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021532s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021532s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2012","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021532s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2012","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021532s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2012","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021532s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2011","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021532s013s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2011","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021532s013s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2005","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021532s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/05\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21532_benicar_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BENICAR HCT","submission":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","actionType":"12.5MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BENICAR HCT","submission":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","actionType":"12.5MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BENICAR HCT","submission":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","actionType":"25MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-08-20
        )

)
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