AMIVAS FDA Approval NDA 213036

NDA 213036

AMIVAS

FDA Drug Application

Application #213036

Documents

Label2020-05-27
Letter2020-05-27
Review2020-06-25

Application Sponsors

NDA 213036AMIVAS

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUS110MG/VIAL1ARTESUNATEARTESUNATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-05-26PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

AMIVAS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213036
            [companyName] => AMIVAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARTESUNATE","activeIngredients":"ARTESUNATE","strength":"110MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/26\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213036s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/26\/2020","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\\\/2020\\\/213036s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213036Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-26
        )

)

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