NOVARTIS FDA Approval NDA 022314

NDA 022314

NOVARTIS

FDA Drug Application

Application #022314

Documents

Letter2011-12-14
Letter2014-03-19
Letter2015-07-30
Label2009-05-11
Label2011-06-27
Label2012-02-17
Label2011-10-31
Label2012-10-01
Label2012-12-10
Label2015-07-30
Summary Review2009-09-02
Letter2009-05-14
Letter2011-06-13
Letter2012-02-21
Letter2011-11-02
Letter2012-01-20
Letter2012-10-02
Letter2012-11-29
Letter2014-03-19
Letter2014-09-25
Label2011-12-13
Label2014-03-19
Label2014-03-19
Label2014-06-10
Label2014-09-26
Review2009-09-02
Letter2019-06-13
Label2019-06-13
Label2020-08-20
Letter2020-08-24
Letter2021-02-23
Label2021-06-30
Letter2022-10-12
Label2022-10-17

Application Sponsors

NDA 022314NOVARTIS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET;ORALEQ 5MG BASE;12.5MG;160MG1EXFORGE HCTAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
002TABLET;ORALEQ 5MG BASE;25MG;160MG1EXFORGE HCTAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
003TABLET;ORALEQ 10MG BASE;12.5MG;160MG1EXFORGE HCTAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
004TABLET;ORALEQ 10MG BASE;25MG;160MG1EXFORGE HCTAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
005TABLET;ORALEQ 10MG BASE;25MG;320MG1EXFORGE HCTAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2009-04-30STANDARD
LABELING; LabelingSUPPL5AP2011-06-03UNKNOWN
LABELING; LabelingSUPPL7AP2011-12-07UNKNOWN
LABELING; LabelingSUPPL9AP2012-02-16UNKNOWN
LABELING; LabelingSUPPL11AP2011-10-31UNKNOWN
LABELING; LabelingSUPPL12AP2012-01-18UNKNOWN
LABELING; LabelingSUPPL13AP2012-09-28UNKNOWN
LABELING; LabelingSUPPL14AP2012-11-28STANDARD
LABELING; LabelingSUPPL15AP2014-03-17STANDARD
LABELING; LabelingSUPPL16AP2014-03-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2014-06-09STANDARD
LABELING; LabelingSUPPL19AP2014-09-24STANDARD
LABELING; LabelingSUPPL20AP2015-07-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2016-02-12STANDARD
LABELING; LabelingSUPPL27AP2019-06-12STANDARD
LABELING; LabelingSUPPL35AP2020-08-20STANDARD
LABELING; LabelingSUPPL36TA2020-10-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2022-09-26N/A

Submissions Property Types

ORIG1Null31
SUPPL5Null7
SUPPL7Null7
SUPPL9Null7
SUPPL11Null7
SUPPL12Null7
SUPPL13Null15
SUPPL14Null6
SUPPL15Null6
SUPPL16Null6
SUPPL17Null0
SUPPL19Null7
SUPPL20Null7
SUPPL22Null0
SUPPL27Null31
SUPPL35Null6
SUPPL36Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

NOVARTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22314
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXFORGE HCT","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 5MG BASE;12.5MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"EXFORGE HCT","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 5MG BASE;25MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"EXFORGE HCT","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 10MG BASE;12.5MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"EXFORGE HCT","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 10MG BASE;25MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"EXFORGE HCT","activeIngredients":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","strength":"EQ 10MG BASE;25MG;320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/26\/2022","submission":"SUPPL-38","supplementCategories":"Manufacturing (CMC)-Facility","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022314Orig1s038lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2021","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022314Orig1s036lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2020","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022314s035lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2019","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022314s027lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022314s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022314s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2014","submission":"SUPPL-17","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022314s017lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/17\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022314s015s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/17\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022314s015s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2012","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022314s014lbl.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\\\/022314s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022314s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/07\/2011","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022314s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2011","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022314s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022314s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022314lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EXFORGE HCT","submission":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"EQ 5MG BASE;12.5MG;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EXFORGE HCT","submission":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"EQ 5MG BASE;25MG;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EXFORGE HCT","submission":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"EQ 10MG BASE;12.5MG;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EXFORGE HCT","submission":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"EQ 10MG BASE;25MG;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EXFORGE HCT","submission":"AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN","actionType":"EQ 10MG BASE;25MG;320MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-09-26
        )

)
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