BOEHRINGER INGELHEIM FDA Approval NDA 020850

NDA 020850

BOEHRINGER INGELHEIM

FDA Drug Application

Application #020850

Documents

Letter1998-11-10
Letter2007-03-06
Letter2009-11-19
Letter2012-01-23
Letter2011-07-07
Letter2012-10-26
Label2005-09-08
Label2009-09-17
Label2009-09-17
Label2009-10-21
Label2012-01-23
Label2012-10-26
Letter2003-10-31
Letter2004-04-07
Letter2005-09-08
Letter2009-11-19
Letter2009-11-20
Letter2012-09-24
Letter2012-01-23
Letter2014-12-15
Label1998-11-10
Label2004-05-06
Label2012-01-23
Label2011-07-12
Label2012-09-24
Label2014-12-15
Review2001-08-06
Other Important Information from FDA2011-12-22
Label2018-02-02
Letter2018-02-02
Letter2022-12-21
Label2022-12-21

Application Sponsors

NDA 020850BOEHRINGER INGELHEIM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL40MG1MICARDISTELMISARTAN
002TABLET;ORAL80MG1MICARDISTELMISARTAN
003TABLET;ORAL20MG1MICARDISTELMISARTAN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1998-11-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1999-12-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2000-04-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-10-12STANDARD
LABELING; LabelingSUPPL5AP2003-10-23STANDARD
LABELING; LabelingSUPPL11AP2004-03-30STANDARD
LABELING; LabelingSUPPL13AP2005-09-02STANDARD
LABELING; LabelingSUPPL19AP2007-02-27STANDARD
LABELING; LabelingSUPPL22AP2009-08-11STANDARD
LABELING; LabelingSUPPL23AP2009-08-11STANDARD
EFFICACY; EfficacySUPPL25AP2009-10-16STANDARD
LABELING; LabelingSUPPL31AP2012-01-18UNKNOWN
LABELING; LabelingSUPPL32AP2011-07-06UNKNOWN
LABELING; LabelingSUPPL33AP2012-09-20UNKNOWN
LABELING; LabelingSUPPL35AP2012-01-19UNKNOWN
LABELING; LabelingSUPPL36AP2012-10-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2015-02-16STANDARD
LABELING; LabelingSUPPL38AP2014-12-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2015-08-05STANDARD
LABELING; LabelingSUPPL40AP2018-02-01STANDARD
LABELING; LabelingSUPPL45AP2022-12-19STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL22Null6
SUPPL23Null6
SUPPL25Null6
SUPPL31Null7
SUPPL32Null6
SUPPL33Null6
SUPPL35Null15
SUPPL36Null6
SUPPL37Null0
SUPPL38Null6
SUPPL39Null0
SUPPL40Null15
SUPPL45Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20850
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICARDIS","activeIngredients":"TELMISARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MICARDIS","activeIngredients":"TELMISARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MICARDIS","activeIngredients":"TELMISARTAN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"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\\\/020850s040lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2014","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020850s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2012","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020850s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2012","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020850s033lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020850s035lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2012","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020850s031lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2011","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020850s032lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2009","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020850s025lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2009","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020850s022s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020850s022s023lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2005","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020850s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2004","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/020850s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20850lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MICARDIS","submission":"TELMISARTAN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MICARDIS","submission":"TELMISARTAN","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MICARDIS","submission":"TELMISARTAN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-02-01
        )

)
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