NDA 213871

PFIZER INC

FDA Drug Application

Application #213871

Documents

• Letter: 2022-01-19
• Label: 2022-01-19
• Medication Guide: 2022-01-19
• Review: 2022-02-10

Application Sponsors

NDA 213871

PFIZER INC

Marketing Status

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

Application Products

001	TABLET;ORAL	50MG	2	CIBINQO	ABROCITINIB
002	TABLET;ORAL	100MG	2	CIBINQO	ABROCITINIB
003	TABLET; ORAL	200MG	2	CIBINQO	ABROCITINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-01-14

PRIORITY

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	TBD
002	Prescription	TBD
003	Prescription	TBD

CDER Filings

PFIZER INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213871
            [companyName] => PFIZER INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/213871s000lbl.pdf#page=26"]
            [products] => [{"drugName":"CIBINQO","activeIngredients":"ABROCITINIB","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"CIBINQO","activeIngredients":"ABROCITINIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"CIBINQO","activeIngredients":"ABROCITINIB","strength":"200MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/14\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213871s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/14\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213871s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213871Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-01-14
        )

)