MITSUBISHI TANABE FDA Approval NDA 215446

NDA 215446

MITSUBISHI TANABE

FDA Drug Application

Application #215446

Documents

Letter2022-05-13
Label2022-05-16

Application Sponsors

NDA 215446MITSUBISHI TANABE

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS105MG/5ML0RADICAVA ORSEDARAVONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-05-12PRIORITY

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD

CDER Filings

MITSUBISHI TANABE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215446
            [companyName] => MITSUBISHI TANABE
            [docInserts] => ["",""]
            [products] => [{"drugName":"RADICAVA ORS","activeIngredients":"EDARAVONE","strength":"105MG\/5ML","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/12\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215446s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/12\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215446s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215446Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-05-12
        )

)

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