NDA 211710

BAYER HEALTHCARE

FDA Drug Application

Application #211710

Documents

• Label: 2018-11-26
• Review: 2018-12-11
• Letter: 2018-12-18
• Label: 2021-03-26
• Label: 2021-03-26
• Letter: 2021-03-29
• Letter: 2021-03-30
• Letter: 2022-11-25
• Label: 2022-11-28

Application Sponsors

NDA 211710

BAYER HEALTHCARE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 20MG BASE/ML

1

VITRAKVI

LAROTRECTINIB SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-11-26	PRIORITY
EFFICACY; Efficacy	SUPPL	4	AP	2021-03-25	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-03-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-11-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	6
SUPPL	8	Null	6

CDER Filings

BAYER HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211710
            [companyName] => BAYER HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VITRAKVI","activeIngredients":"LAROTRECTINIB SULFATE","strength":"EQ 20MG BASE\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/26\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211710s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211710s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211710Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210861Orig1s000_21171Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-11-26
        )

)