AMGEN INC FDA Approval NDA 214665

NDA 214665

AMGEN INC

FDA Drug Application

Application #214665

Documents

Label2021-05-28
Letter2021-06-01

Application Sponsors

NDA 214665AMGEN INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL120MG0LUMAKRASSOTORASIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-05-28PRIORITY

Submissions Property Types

ORIG1Null30

CDER Filings

AMGEN INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214665
            [companyName] => AMGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUMAKRAS","activeIngredients":"SOTORASIB","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/28\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214665s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214665s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214665Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-28
        )

)

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