NDA 215446

MITSUBISHI TANABE

FDA Drug Application

Application #215446

Documents

• Letter: 2022-05-13
• Label: 2022-05-16

Application Sponsors

NDA 215446

MITSUBISHI TANABE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

105MG/5ML

0

RADICAVA ORS

EDARAVONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-05-12

PRIORITY

Submissions Property Types

ORIG

1

Null

6

TE Codes

001

Prescription

TBD

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
        )

)