BOEHRINGER INGELHEIM FDA Approval NDA 022401

NDA 022401

BOEHRINGER INGELHEIM

FDA Drug Application

Application #022401

Documents

Letter2011-06-07
Letter2012-10-23
Letter2011-11-16
Letter2012-04-02
Letter2014-12-15
Letter2016-01-15
Label2009-10-16
Label2012-01-23
Label2012-10-22
Label2012-10-22
Label2011-11-14
Label2012-03-30
Label2014-12-16
Summary Review2010-03-31
Letter2009-11-02
Letter2010-07-29
Letter2012-01-23
Letter2012-10-23
Letter2012-11-16
Label2010-07-31
Label2011-06-06
Label2012-11-15
Label2016-01-25
Review2010-03-31
Label2018-02-02
Letter2018-02-02

Application Sponsors

NDA 022401BOEHRINGER INGELHEIM

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORALEQ 5MG BASE;40MG1TWYNSTAAMLODIPINE BESYLATE; TELMISARTAN
002TABLET;ORALEQ 10MG BASE;40MG1TWYNSTAAMLODIPINE BESYLATE; TELMISARTAN
003TABLET;ORALEQ 5MG BASE;80MG1TWYNSTAAMLODIPINE BESYLATE; TELMISARTAN
004TABLET;ORALEQ 10MG BASE;80MG1TWYNSTAAMLODIPINE BESYLATE; TELMISARTAN

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2009-10-16STANDARD
LABELING; LabelingSUPPL2AP2010-07-27UNKNOWN
LABELING; LabelingSUPPL4AP2012-01-18UNKNOWN
LABELING; LabelingSUPPL5AP2011-06-06UNKNOWN
LABELING; LabelingSUPPL7AP2012-10-19UNKNOWN
LABELING; LabelingSUPPL9AP2012-10-19UNKNOWN
LABELING; LabelingSUPPL10AP2011-11-14UNKNOWN
LABELING; LabelingSUPPL11AP2012-03-29STANDARD
LABELING; LabelingSUPPL12AP2012-11-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2014-12-11STANDARD
LABELING; LabelingSUPPL16AP2014-12-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2015-11-19STANDARD
LABELING; LabelingSUPPL18AP2016-01-13STANDARD
LABELING; LabelingSUPPL19AP2018-02-01STANDARD

Submissions Property Types

ORIG1Null40
SUPPL2Null6
SUPPL4Null6
SUPPL5Null6
SUPPL7Null7
SUPPL9Null7
SUPPL10Null15
SUPPL11Null6
SUPPL12Null6
SUPPL14Null0
SUPPL16Null15
SUPPL17Null0
SUPPL18Null15
SUPPL19Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22401
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"TWYNSTA","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 5MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TWYNSTA","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 10MG BASE;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TWYNSTA","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 5MG BASE;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TWYNSTA","activeIngredients":"AMLODIPINE BESYLATE; TELMISARTAN","strength":"EQ 10MG BASE;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/01\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022401s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022401s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022401s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022401s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022401s007s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022401s007s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022401s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2012","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022401s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022401s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2011","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022401s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022401s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022401lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TWYNSTA","submission":"AMLODIPINE BESYLATE; TELMISARTAN","actionType":"EQ 5MG BASE;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TWYNSTA","submission":"AMLODIPINE BESYLATE; TELMISARTAN","actionType":"EQ 10MG BASE;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TWYNSTA","submission":"AMLODIPINE BESYLATE; TELMISARTAN","actionType":"EQ 5MG BASE;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TWYNSTA","submission":"AMLODIPINE BESYLATE; TELMISARTAN","actionType":"EQ 10MG BASE;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-02-01
        )

)
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