NOVARTIS FDA Approval NDA 022545

NDA 022545

NOVARTIS

FDA Drug Application

Application #022545

Documents

Letter2010-08-31
Letter2012-10-02
Letter2012-04-18
Letter2012-10-02
Letter2013-11-06
Letter2015-12-23
Label2010-08-27
Label2011-10-20
Label2011-11-14
Label2012-04-16
Label2012-10-01
Label2013-11-04
Label2014-03-19
Label2015-12-28
Review2011-05-25
Letter2011-04-01
Letter2011-10-14
Letter2012-02-07
Letter2011-11-16
Letter2012-02-06
Letter2015-04-01
Label2011-04-01
Label2012-01-31
Label2012-02-06
Label2012-10-01
Label2015-04-02
Summary Review2011-05-25
Letter2016-11-08
Label2016-11-08

Application Sponsors

NDA 022545NOVARTIS

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET;ORALEQ 150MG BASE;EQ 5MG BASE0TEKAMLOALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
002TABLET;ORALEQ 150MG BASE;EQ 10MG BASE0TEKAMLOALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
003TABLET;ORALEQ 300MG BASE;EQ 5MG BASE0TEKAMLOALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
004TABLET;ORALEQ 300MG BASE;EQ 10MG BASE0TEKAMLOALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2010-08-26STANDARD
LABELING; LabelingSUPPL5AP2011-10-12UNKNOWN
LABELING; LabelingSUPPL7AP2012-01-26UNKNOWN
LABELING; LabelingSUPPL8AP2011-11-14UNKNOWN
LABELING; LabelingSUPPL10AP2012-02-02UNKNOWN
LABELING; LabelingSUPPL11AP2012-09-28UNKNOWN
LABELING; LabelingSUPPL12AP2012-04-16UNKNOWN
LABELING; LabelingSUPPL13AP2012-09-28UNKNOWN
LABELING; LabelingSUPPL14AP2013-11-04STANDARD
LABELING; LabelingSUPPL15AP2014-03-18STANDARD
LABELING; LabelingSUPPL16AP2015-03-27STANDARD
LABELING; LabelingSUPPL17AP2015-12-22STANDARD
LABELING; LabelingSUPPL20AP2016-11-04STANDARD

Submissions Property Types

ORIG1Null6
SUPPL5Null7
SUPPL7Null7
SUPPL8Null7
SUPPL10Null7
SUPPL11Null7
SUPPL12Null15
SUPPL13Null6
SUPPL14Null6
SUPPL15Null6
SUPPL16Null7
SUPPL17Null7
SUPPL20Null6

CDER Filings

NOVARTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22545
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEKAMLO","activeIngredients":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE","strength":"EQ 150MG BASE;EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEKAMLO","activeIngredients":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE","strength":"EQ 150MG BASE;EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEKAMLO","activeIngredients":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE","strength":"EQ 300MG BASE;EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEKAMLO","activeIngredients":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE","strength":"EQ 300MG BASE;EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/04\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022545s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022545s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2015","submission":"SUPPL-17","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022545s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2015","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022545s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022545s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022545s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022545s014lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022545s011s013.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022545s011s013.pdf\"}]","notes":""},{"actionDate":"04\/16\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022545s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2012","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022545s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022545s007lbledt.pdf\"}]","notes":""},{"actionDate":"11\/14\/2011","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022545s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022545s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022545s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022545s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TEKAMLO","submission":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE","actionType":"EQ 150MG BASE;EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TEKAMLO","submission":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE","actionType":"EQ 150MG BASE;EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TEKAMLO","submission":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE","actionType":"EQ 300MG BASE;EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TEKAMLO","submission":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE","actionType":"EQ 300MG BASE;EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2016-11-04
        )

)
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