AMGEN INC FDA Approval BLA 761140

BLA 761140

AMGEN INC

FDA Drug Application

Application #761140

Documents

Label2020-12-17
Medication Guide2020-12-17
Letter2020-12-21

Application Sponsors

BLA 761140AMGEN INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG/10ML(10MG/ML)2RIABNIRITUXIMAB-ARRX

FDA Submissions

UNKNOWN; ORIG1AP2020-12-17STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

AMGEN INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761140
            [companyName] => AMGEN INC
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761140s000lbl.pdf#page=31"]
            [products] => [{"drugName":"RIABNI","activeIngredients":"RITUXIMAB-ARRX","strength":"100MG\/10ML(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761140s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761140s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761140Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-12-17
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.