NDA 211288

PFIZER INC

FDA Drug Application

Application #211288

Documents

• Label: 2018-09-27
• Letter: 2018-09-27
• Review: 2018-10-30
• Letter: 2020-12-22
• Label: 2020-12-23

Application Sponsors

NDA 211288

PFIZER INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	15MG	1	VIZIMPRO	DACOMITINIB
002	TABLET;ORAL	30MG	1	VIZIMPRO	DACOMITINIB
003	TABLET;ORAL	45MG	1	VIZIMPRO	DACOMITINIB

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2018-09-27	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2020-12-18	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	6

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211288
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIZIMPRO","activeIngredients":"DACOMITINIB","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIZIMPRO","activeIngredients":"DACOMITINIB","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIZIMPRO","activeIngredients":"DACOMITINIB","strength":"45MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/27\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211288s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211288s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211288Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/211288Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-09-27
        )

)