LA JOLLA PHARMA FDA Approval NDA 213170

NDA 213170

LA JOLLA PHARMA

FDA Drug Application

Application #213170

Documents

Letter2020-06-02

Application Sponsors

NDA 213170LA JOLLA PHARMA

Marketing Status

None (Tentative Approval)001

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1TA2020-05-29PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

LA JOLLA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213170
            [companyName] => LA JOLLA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARTESUNATE","activeIngredients":"ARTESUNATE","strength":"UNKNOWN","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/29\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213170Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-29
        )

)

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