NOVARTIS FDA Approval NDA 022059

NDA 022059

NOVARTIS

FDA Drug Application

Application #022059

Documents

Letter2007-05-01
Letter2010-03-09
Letter2010-03-09
Letter2010-02-05
Label2007-05-01
Label2010-02-01
Label2008-07-09
Label2010-02-01
Label2011-08-12
Label2013-06-25
Label2013-06-25
Label2015-01-05
Letter2007-03-15
Letter2007-08-22
Letter2008-07-10
Letter2011-08-15
Letter2011-08-15
Letter2012-02-21
Letter2013-06-24
Letter2013-10-22
Letter2013-10-22
Letter2013-06-24
Letter2015-04-02
Letter2014-12-30
Label2007-03-13
Label2007-08-21
Label2010-02-01
Label2011-08-12
Label2012-02-17
Label2013-10-22
Label2013-10-22
Label2015-04-01
Review2007-05-09
Label2017-04-05
Letter2017-04-12
Label2018-12-07
Label2018-12-07
Letter2018-12-07
Letter2018-12-07
Review2019-09-24
Review2020-10-06
Label2022-03-28
Letter2022-03-28

Application Sponsors

NDA 022059NOVARTIS

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 250MG BASE1TYKERBLAPATINIB DITOSYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2007-03-13PRIORITY
LABELING; LabelingSUPPL2AP2007-08-20STANDARD
LABELING; LabelingSUPPL3AP2010-01-29STANDARD
LABELING; LabelingSUPPL4AP2008-07-07STANDARD
LABELING; LabelingSUPPL6AP2010-01-29STANDARD
EFFICACY; EfficacySUPPL7AP2010-01-29STANDARD
LABELING; LabelingSUPPL11AP2011-08-12UNKNOWN
LABELING; LabelingSUPPL12AP2011-08-12UNKNOWN
LABELING; LabelingSUPPL13AP2012-03-02UNKNOWN
LABELING; LabelingSUPPL15AP2013-06-21STANDARD
EFFICACY; EfficacySUPPL16AP2013-10-18STANDARD
EFFICACY; EfficacySUPPL17AP2013-10-18STANDARD
LABELING; LabelingSUPPL18AP2013-06-21STANDARD
LABELING; LabelingSUPPL20AP2015-03-31STANDARD
LABELING; LabelingSUPPL21AP2014-12-22901 REQUIRED
LABELING; LabelingSUPPL22AP2017-04-06STANDARD
EFFICACY; EfficacySUPPL23AP2018-12-06STANDARD
LABELING; LabelingSUPPL24AP2018-12-06STANDARD
LABELING; LabelingSUPPL31AP2022-03-27STANDARD

Submissions Property Types

ORIG1Null2
SUPPL3Null7
SUPPL6Null7
SUPPL7Null7
SUPPL11Null15
SUPPL12Null6
SUPPL13Null6
SUPPL15Null6
SUPPL16Null6
SUPPL17Null7
SUPPL18Null7
SUPPL20Null7
SUPPL21Null15
SUPPL22Null6
SUPPL23Null6
SUPPL24Null6
SUPPL31Null7

TE Codes

001PrescriptionAB

CDER Filings

NOVARTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22059
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TYKERB","activeIngredients":"LAPATINIB DITOSYLATE","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/27\/2022","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022059s031lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2022","submission":"SUPPL-31","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022059s031lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022059s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2018","submission":"SUPPL-23","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022059s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022059s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022059s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2014","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022059Orig1s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2013","submission":"SUPPL-17","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022059s016s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2013","submission":"SUPPL-16","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022059s016s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022059s015s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022059s015s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022059s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2011","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022059s011s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2011","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022059s011s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2010","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022059s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2010","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022059s3s6lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2010","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022059s3s6lbl.pdf\"}]","notes":""},{"actionDate":"07\/07\/2008","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022059s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2007","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022059s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2007","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022059s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022059lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TYKERB","submission":"LAPATINIB DITOSYLATE","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-03-27
        )

)
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