PFIZER INC FDA Approval BLA 761118

BLA 761118

PFIZER INC

FDA Drug Application

Application #761118

Documents

Label2019-11-18
Medication Guide2019-11-18
Letter2019-11-19
Review2020-01-28

Application Sponsors

BLA 761118PFIZER INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION40MG/0.8ML0ABRILADAADALIMUMAB-AFZB
002INJECTABLE;INJECTION20MG/0.4ML0ABRILADAADALIMUMAB-AFZB
003INJECTABLE;INJECTION10MG/0.2ML0ABRILADAADALIMUMAB-AFZB

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2019-11-15STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

PFIZER INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761118
            [companyName] => PFIZER INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761118s000lbl.pdf#page=39"]
            [products] => [{"drugName":"ABRILADA","activeIngredients":"ADALIMUMAB-AFZB","strength":"40MG\/0.8ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ABRILADA","activeIngredients":"ADALIMUMAB-AFZB","strength":"20MG\/0.4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ABRILADA","activeIngredients":"ADALIMUMAB-AFZB","strength":"10MG\/0.2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/15\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761118s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761118s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761118Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761118Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-11-15
        )

)

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