ATHENEX INC FDA Approval NDA 213189

NDA 213189

ATHENEX INC

FDA Drug Application

Application #213189

Documents

Label2020-12-15
Letter2020-12-15
Review2020-12-28

Application Sponsors

NDA 213189ATHENEX INC

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICAL1%2KLISYRITIRBANIBULIN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-12-14STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

ATHENEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213189
            [companyName] => ATHENEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KLISYRI","activeIngredients":"TIRBANIBULIN","strength":"1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/14\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213189s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213189s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213189Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-12-14
        )

)

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