NDA 211225

NOVARTIS

FDA Drug Application

Application #211225

Documents

• Label: 2019-03-19
• Letter: 2019-03-19
• Review: 2019-04-26
• Label: 2021-08-22
• Letter: 2021-08-24
• Letter: 2021-10-12
• Label: 2021-10-13

Application Sponsors

NDA 211225

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

150MG

1

ZYKADIA

CERITINIB

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-03-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-08-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-10-07	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7
SUPPL	4	Null	7

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211225
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYKADIA","activeIngredients":"CERITINIB","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/07\/2021","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211225s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2021","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211225s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211225s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211225s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211225s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211225Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211225Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/07\/2021","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211225s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211225Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"08\/19\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211225s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211225Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-10-07
        )

)