NDA 212436

PFIZER INC

FDA Drug Application

Application #212436

Documents

• Label: 2019-11-04
• Letter: 2019-11-12
• Review: 2020-04-06
• Label: 2022-12-14
• Letter: 2022-12-14

Application Sponsors

NDA 212436

PFIZER INC

Marketing Status

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

Application Products

001	TABLET;ORAL	75MG	1	IBRANCE	PALBOCICLIB
002	TABLET;ORAL	100MG	1	IBRANCE	PALBOCICLIB
003	TABLET;ORAL	125MG	1	IBRANCE	PALBOCICLIB

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-11-01	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2022-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	6

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212436
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBRANCE","activeIngredients":"PALBOCICLIB","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"IBRANCE","activeIngredients":"PALBOCICLIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"IBRANCE","activeIngredients":"PALBOCICLIB","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/01\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212436lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212436lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212436Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212436Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-11-01
        )

)