ABBVIE FDA Approval NDA 020591

NDA 020591

ABBVIE

FDA Drug Application

Application #020591

Documents

Letter2008-03-04
Letter2011-08-31
Letter2011-11-16
Letter2014-12-30
Letter2016-02-01
Label2011-08-29
Label2012-01-23
Label2015-01-08
Label2016-07-13
Letter2009-03-06
Letter2011-09-16
Letter2012-01-30
Letter2012-09-14
Letter2016-07-13
Label2011-09-16
Label2011-11-14
Label2012-09-14
Label2016-02-02
Label2017-08-04
Letter2017-08-04
Letter2019-08-21
Label2019-08-22

Application Sponsors

NDA 020591ABBVIE

Marketing Status

Prescription001
Prescription002
Discontinued003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORAL2MG;180MG1TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL4MG;240MG1TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORAL1MG;240MG1TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORAL2MG;240MG1TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP1996-10-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1999-09-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-03-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-07-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2002-05-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-08-20STANDARD
LABELING; LabelingSUPPL11AP2008-02-29STANDARD
LABELING; LabelingSUPPL12AP2011-08-29STANDARD
LABELING; LabelingSUPPL16AP2009-03-05STANDARD
LABELING; LabelingSUPPL18AP2011-09-14UNKNOWN
LABELING; LabelingSUPPL19AP2011-11-14UNKNOWN
LABELING; LabelingSUPPL20AP2012-01-23UNKNOWN
LABELING; LabelingSUPPL21AP2012-09-12UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2014-10-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2015-01-05STANDARD
LABELING; LabelingSUPPL25AP2014-12-24STANDARD
LABELING; LabelingSUPPL26AP2016-01-29STANDARD
LABELING; LabelingSUPPL27AP2016-07-12STANDARD
LABELING; LabelingSUPPL29AP2017-08-02STANDARD
LABELING; LabelingSUPPL30AP2019-08-20STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL12Null15
SUPPL18Null7
SUPPL19Null7
SUPPL20Null15
SUPPL21Null6
SUPPL22Null0
SUPPL24Null0
SUPPL25Null15
SUPPL26Null6
SUPPL27Null6
SUPPL29Null15
SUPPL30Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
004PrescriptionAB

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20591
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TARKA","activeIngredients":"TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE","strength":"2MG;180MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TARKA","activeIngredients":"TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE","strength":"4MG;240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TARKA","activeIngredients":"TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE","strength":"1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TARKA","activeIngredients":"TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE","strength":"2MG;240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/20\/2019","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020591s030lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2017","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020591s029lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2016","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020591s027lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2016","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020591s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/24\/2014","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020591s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2012","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020591s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2012","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020528s020,020591s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2011","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020591s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2011","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020591s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2011","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020591s012lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TARKA","submission":"TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE","actionType":"2MG;180MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TARKA","submission":"TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE","actionType":"4MG;240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TARKA","submission":"TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE","actionType":"1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TARKA","submission":"TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE","actionType":"2MG;240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-20
        )

)
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