NOVARTIS FDA Approval NDA 200045

NDA 200045

NOVARTIS

FDA Drug Application

Application #200045

Documents

Letter2010-12-28
Letter2011-10-14
Letter2011-11-07
Letter2012-02-06
Letter2012-10-02
Letter2012-10-02
Letter2015-12-23
Label2010-12-26
Label2011-10-20
Label2011-11-04
Label2012-02-06
Label2013-11-04
Label2015-04-02
Label2015-12-28
Review2011-08-15
Summary Review2011-08-15
Letter2011-10-14
Letter2012-02-17
Letter2012-01-30
Letter2012-04-18
Letter2013-11-06
Letter2015-04-01
Label2011-10-20
Label2012-02-17
Label2012-01-31
Label2012-10-01
Label2012-04-16
Label2012-10-01
Label2014-03-19
Letter2016-11-08
Label2016-11-08

Application Sponsors

NDA 200045NOVARTIS

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005

Application Products

001TABLET;ORALEQ 150MG BASE;EQ 5MG BASE;12.5MG0AMTURNIDEALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
002TABLET;ORALEQ 300MG BASE;EQ 5MG BASE;12.5MG0AMTURNIDEALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
003TABLET;ORALEQ 300MG BASE;EQ 5MG BASE;25MG0AMTURNIDEALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
004TABLET;ORALEQ 300MG BASE;EQ 10MG BASE;12.5MG0AMTURNIDEALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
005TABLET;ORALEQ 300MG BASE;EQ 10MG BASE;25MG0AMTURNIDEALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2010-12-21STANDARD
LABELING; LabelingSUPPL3AP2011-10-12UNKNOWN
LABELING; LabelingSUPPL4AP2011-10-12UNKNOWN
LABELING; LabelingSUPPL6AP2012-02-14UNKNOWN
LABELING; LabelingSUPPL7AP2012-01-26UNKNOWN
LABELING; LabelingSUPPL9AP2011-11-02UNKNOWN
LABELING; LabelingSUPPL10AP2012-02-02UNKNOWN
LABELING; LabelingSUPPL11AP2012-09-28UNKNOWN
LABELING; LabelingSUPPL12AP2012-04-18UNKNOWN
LABELING; LabelingSUPPL13AP2012-09-28
LABELING; LabelingSUPPL14AP2013-11-04STANDARD
LABELING; LabelingSUPPL15AP2014-03-18STANDARD
LABELING; LabelingSUPPL16AP2015-03-27STANDARD
LABELING; LabelingSUPPL17AP2015-12-22STANDARD
LABELING; LabelingSUPPL20AP2016-11-04STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL4Null15
SUPPL6Null15
SUPPL7Null15
SUPPL9Null15
SUPPL10Null15
SUPPL11Null6
SUPPL12Null6
SUPPL13Null7
SUPPL14Null15
SUPPL15Null6
SUPPL16Null6
SUPPL17Null6
SUPPL20Null15

CDER Filings

NOVARTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200045
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMTURNIDE","activeIngredients":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE","strength":"EQ 150MG BASE;EQ 5MG BASE;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMTURNIDE","activeIngredients":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE","strength":"EQ 300MG BASE;EQ 5MG BASE;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMTURNIDE","activeIngredients":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE","strength":"EQ 300MG BASE;EQ 5MG BASE;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMTURNIDE","activeIngredients":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE","strength":"EQ 300MG BASE;EQ 10MG BASE;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMTURNIDE","activeIngredients":"ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE","strength":"EQ 300MG BASE;EQ 10MG BASE;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"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\\\/200045s020lbl.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\\\/200045s017lbl.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\\\/200045s016lbl.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\\\/200045s015lbl.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\\\/200045s014lbl.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\\\/200045s011s013lbl.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\\\/200045s011s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200045s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200045s006lbl.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\\\/200045s010lbl.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\\\/200045s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200045s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200045s003s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2011","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200045s003s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200045s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/21\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/200045s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/200045s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200045s000_amturnide_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/200045Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"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\\\/200045s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/200045Orig1s020ltr.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\\\/200045s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200045Orig1s017ltr.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\\\/200045s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200045Orig1s016ltr.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\\\/200045s015lbl.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\\\/200045s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200045Orig1s014ltr.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\\\/200045s011s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200045Orig1s011,s013ltr.pdf\"}]","notes":">"},{"actionDate":"04\/18\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200045s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200045Orig1s012ltr_rev1rev2nh_Redacted.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\\\/200045s011s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200045Orig1s011,s013ltr.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\\\/200045s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200045s010ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200045s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200045s009ltr.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\\\/200045s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200045s007ltr.pdf\"}]","notes":">"},{"actionDate":"02\/14\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/200045s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200045s006ltr.pdf\"}]","notes":">"},{"actionDate":"10\/12\/2011","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200045s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200045s003,s004ltr.pdf\"}]","notes":">"},{"actionDate":"10\/12\/2011","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200045s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200045s003,s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2016-11-04
        )

)
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