BOEHRINGER INGELHEIM FDA Approval NDA 022512

NDA 022512

BOEHRINGER INGELHEIM

FDA Drug Application

Application #022512

Documents

Letter2011-04-07
Letter2011-11-14
Letter2012-11-06
Letter2013-12-13
Letter2014-08-15
Letter2015-01-20
Letter2014-09-08
Letter2015-09-14
Letter2015-11-23
Letter2015-10-26
Label2010-10-20
Label2012-05-01
Label2012-06-11
Label2015-09-21
Review2010-11-30
Review2013-06-04
Medication Guide2013-01-03
Summary Review2011-02-17
Letter2010-10-20
Letter2011-03-08
Letter2012-01-19
Letter2012-05-02
Letter2012-06-05
Letter2012-12-26
Letter2013-04-30
Letter2014-04-09
Letter2015-08-28
Label2011-03-07
Label2011-11-10
Label2012-01-23
Label2012-11-06
Label2012-12-21
Label2013-04-29
Label2014-04-08
Label2013-12-11
Label2014-08-15
Label2015-01-20
Label2014-09-26
Label2015-09-11
Label2015-11-25
Label2015-10-27
Review2013-04-10
Other Important Information from FDA2011-03-29
Label2018-03-15
Letter2018-03-15
Label2019-11-25
Medication Guide2019-11-25
Letter2019-11-26
Label2020-07-02
Medication Guide2020-07-02
Letter2020-07-06
Letter2021-04-22
Label2021-04-22
Label2021-06-22
Medication Guide2021-06-22
Letter2021-06-23

Application Sponsors

NDA 022512BOEHRINGER INGELHEIM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 75MG BASE1PRADAXADABIGATRAN ETEXILATE MESYLATE
002CAPSULE;ORALEQ 150MG BASE1PRADAXADABIGATRAN ETEXILATE MESYLATE
003CAPSULE;ORALEQ 110MG BASE1PRADAXADABIGATRAN ETEXILATE MESYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2010-10-19PRIORITY
LABELING; LabelingSUPPL4AP2011-03-04UNKNOWN
REMS; REMSSUPPL5AP2011-04-05N/A
LABELING; LabelingSUPPL7AP2011-11-09UNKNOWN
LABELING; LabelingSUPPL9AP2012-01-17UNKNOWN
LABELING; LabelingSUPPL10AP2012-04-27UNKNOWN
LABELING; LabelingSUPPL11AP2012-05-31UNKNOWN
LABELING; LabelingSUPPL14AP2012-11-02UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2012-11-20PRIORITY
LABELING; LabelingSUPPL16AP2012-12-19STANDARD
LABELING; LabelingSUPPL17AP2013-04-25STANDARD
EFFICACY; EfficacySUPPL18AP2014-04-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2013-10-18PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2014-04-16PRIORITY
LABELING; LabelingSUPPL21AP2013-12-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2014-07-25PRIORITY
LABELING; LabelingSUPPL23AP2014-08-14STANDARD
LABELING; LabelingSUPPL24AP2015-01-15STANDARD
LABELING; LabelingSUPPL25AP2014-09-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2015-04-07PRIORITY
LABELING; LabelingSUPPL27AP2015-09-10STANDARD
EFFICACY; EfficacySUPPL28AP2015-11-20STANDARD
LABELING; LabelingSUPPL31AP2015-08-26STANDARD
LABELING; LabelingSUPPL32AP2015-10-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2016-07-28PRIORITY
LABELING; LabelingSUPPL35AP2018-03-13STANDARD
LABELING; LabelingSUPPL38AP2019-11-22STANDARD
LABELING; LabelingSUPPL39AP2020-07-01STANDARD
EFFICACY; EfficacySUPPL41AP2021-06-21PRIORITY
LABELING; LabelingSUPPL42AP2021-04-20STANDARD

Submissions Property Types

ORIG1Null31
SUPPL4Null7
SUPPL5Null6
SUPPL7Null15
SUPPL9Null7
SUPPL10Null15
SUPPL11Null6
SUPPL14Null7
SUPPL15Null0
SUPPL16Null15
SUPPL17Null6
SUPPL18Null6
SUPPL19Null0
SUPPL20Null0
SUPPL21Null6
SUPPL22Null0
SUPPL23Null15
SUPPL24Null6
SUPPL25Null6
SUPPL26Null0
SUPPL27Null15
SUPPL28Null6
SUPPL31Null15
SUPPL32Null15
SUPPL33Null0
SUPPL35Null7
SUPPL38Null6
SUPPL39Null6
SUPPL41Null7
SUPPL42Null6

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22512
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/022512s039lbl.pdf#page=24"]
            [products] => [{"drugName":"PRADAXA","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PRADAXA","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"PRADAXA","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 110MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/01\/2020","submission":"SUPPL-39","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022512s039lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022512s038lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2018","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022512s035lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2015","submission":"SUPPL-28","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022512s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2015","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022512s032lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2015","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022512s027lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2015","submission":"SUPPL-31","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022512Orig1s031lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2015","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022512s024lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2014","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022512s025.pdf\"}]","notes":""},{"actionDate":"08\/14\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022512s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2014","submission":"SUPPL-18","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022512s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2013","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022512s021lbl.pdf\"}]","notes":""},{"actionDate":"04\/25\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022512s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2012","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022512s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2012","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022512s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022512s011lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2012","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022512s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022512s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2011","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022512s007lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022512s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022512s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PRADAXA","submission":"DABIGATRAN ETEXILATE MESYLATE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRADAXA","submission":"DABIGATRAN ETEXILATE MESYLATE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRADAXA","submission":"DABIGATRAN ETEXILATE MESYLATE","actionType":"EQ 110MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-07-01
        )

)
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