PFIZER INC FDA Approval NDA 213082

NDA 213082

PFIZER INC

FDA Drug Application

Application #213082

Documents

Label2020-09-29
Letter2020-09-29
Medication Guide2020-09-29

Application Sponsors

NDA 213082PFIZER INC

Marketing Status

Prescription001

Application Products

001SOLUTION; ORAL5MG0XELJANZTOFACITINIB

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-09-25PRIORITY

Submissions Property Types

ORIG1Null6

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
        )

)

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