BOEHRINGER INGELHEIM FDA Approval NDA 021162

NDA 021162

BOEHRINGER INGELHEIM

FDA Drug Application

Application #021162

Documents

Letter2007-03-06
Letter2009-11-25
Letter2012-01-23
Letter2012-01-23
Letter2012-10-26
Label2009-09-17
Label2012-01-23
Label2011-05-27
Label2012-01-23
Label2012-11-07
Other Important Information from FDA2011-12-22
Letter2000-11-17
Letter2004-04-29
Letter2005-09-08
Letter2009-11-25
Letter2011-05-06
Letter2011-05-06
Letter2016-01-14
Letter2014-12-15
Label2000-11-17
Label2005-09-08
Label2009-09-17
Label2011-05-27
Label2016-01-25
Label2014-12-16
Review2004-03-11
Label2018-02-02
Letter2018-02-02
Label2020-08-21
Letter2020-08-21
Letter2022-12-21
Label2022-12-21

Application Sponsors

NDA 021162BOEHRINGER INGELHEIM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL12.5MG;40MG1MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTAN
002TABLET;ORAL12.5MG;80MG1MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTAN
003TABLET;ORAL25MG;80MG1MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTAN

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2000-11-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2004-04-19STANDARD
LABELING; LabelingSUPPL8AP2005-09-02STANDARD
LABELING; LabelingSUPPL16AP2007-02-27STANDARD
LABELING; LabelingSUPPL19AP2009-08-11STANDARD
LABELING; LabelingSUPPL20AP2009-08-11STANDARD
LABELING; LabelingSUPPL29AP2011-05-12UNKNOWN
LABELING; LabelingSUPPL30AP2012-01-20UNKNOWN
LABELING; LabelingSUPPL31AP2011-05-12UNKNOWN
LABELING; LabelingSUPPL32AP2016-01-12UNKNOWN
LABELING; LabelingSUPPL34AP2012-01-19UNKNOWN
LABELING; LabelingSUPPL35AP2012-10-24STANDARD
LABELING; LabelingSUPPL37AP2014-12-12STANDARD
LABELING; LabelingSUPPL40AP2018-02-01STANDARD
LABELING; LabelingSUPPL45AP2020-08-20STANDARD
LABELING; LabelingSUPPL47AP2022-12-19STANDARD

Submissions Property Types

SUPPL5Null0
SUPPL19Null6
SUPPL20Null6
SUPPL29Null7
SUPPL30Null15
SUPPL31Null6
SUPPL32Null6
SUPPL34Null15
SUPPL35Null6
SUPPL37Null6
SUPPL40Null7
SUPPL45Null7
SUPPL47Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21162
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICARDIS HCT","activeIngredients":"HYDROCHLOROTHIAZIDE; TELMISARTAN","strength":"12.5MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MICARDIS HCT","activeIngredients":"HYDROCHLOROTHIAZIDE; TELMISARTAN","strength":"12.5MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MICARDIS HCT","activeIngredients":"HYDROCHLOROTHIAZIDE; TELMISARTAN","strength":"25MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021162s045lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2018","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021162s040lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021162s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2014","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021162s037lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021162s035lbl.pdf\"}]","notes":""},{"actionDate":"01\/20\/2012","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021162s030lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2012","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021162s034lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2011","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021162s029s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2011","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021162s029s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2009","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021162s019s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2009","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021162s019s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2005","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021162s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21162lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MICARDIS HCT","submission":"HYDROCHLOROTHIAZIDE; TELMISARTAN","actionType":"12.5MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MICARDIS HCT","submission":"HYDROCHLOROTHIAZIDE; TELMISARTAN","actionType":"12.5MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MICARDIS HCT","submission":"HYDROCHLOROTHIAZIDE; TELMISARTAN","actionType":"25MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-08-20
        )

)
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