NDA 212726

GENENTECH INC

FDA Drug Application

Application #212726

Documents

• Label: 2019-08-16
• Letter: 2019-09-16
• Review: 2019-09-16
• Pediatric Other: 1900-01-01

Application Sponsors

NDA 212726

GENENTECH INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	100MG	2	ROZLYTREK	ENTRECTINIB
002	CAPSULE;ORAL	200MG	2	ROZLYTREK	ENTRECTINIB

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval

ORIG

1

AP

2019-08-15

PRIORITY

Submissions Property Types

ORIG

1

Null

30

TE Codes

001	Prescription	TBD
002	Prescription	TBD

CDER Filings

GENENTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212726
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROZLYTREK","activeIngredients":"ENTRECTINIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"ROZLYTREK","activeIngredients":"ENTRECTINIB","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"08\/15\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212726s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212726s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212726Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212725Orig1s000,%20212726Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-08-15
        )

)