NDA 213082

PFIZER INC

FDA Drug Application

Application #213082

Documents

• Label: 2020-09-29
• Letter: 2020-09-29
• Medication Guide: 2020-09-29
• Review: 2020-10-29
• Label: 2021-12-03
• Medication Guide: 2021-12-03
• Letter: 2021-12-06
• Label: 2021-12-15
• Medication Guide: 2021-12-15
• Letter: 2021-12-16

Application Sponsors

NDA 213082

PFIZER INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; ORAL

5MG

0

XELJANZ

TOFACITINIB

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2020-09-25	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2021-12-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-12-02	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7
SUPPL	4	Null	6

CDER Filings

PFIZER INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213082
            [companyName] => PFIZER INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/213082s000lbl.pdf#page=60"]
            [products] => [{"drugName":"XELJANZ","activeIngredients":"TOFACITINIB","strength":"5MG","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/25\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213082s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213082s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213082Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-09-25
        )

)