MYLAN PHARMS INC FDA Approval BLA 761154

BLA 761154

MYLAN PHARMS INC

FDA Drug Application

Application #761154

Documents

Label2020-07-07
Medication Guide2020-07-07
Letter2020-07-07

Application Sponsors

BLA 761154MYLAN PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION20MG;0.4ML0HULIOADALIMUMAB-FKJP

FDA Submissions

UNKNOWN; ORIG1AP2020-07-06PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761154
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761154s000lbl.pdf#page=41"]
            [products] => [{"drugName":"HULIO","activeIngredients":"ADALIMUMAB-FKJP","strength":"20MG;0.4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761154s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761154s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761154Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-06
        )

)

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