NDA 209176

MITSUBISHI TANABE

FDA Drug Application

Application #209176

Documents

• Label: 2017-05-08
• Letter: 2017-05-09
• Review: 2017-06-20
• Label: 2019-04-15
• Letter: 2019-06-11
• Review: 2019-08-07
• Label: 2019-11-05
• Letter: 2019-11-05
• Label: 2021-03-16
• Letter: 2021-03-17
• Label: 2022-11-20
• Letter: 2022-11-22

Application Sponsors

NDA 209176

MITSUBISHI TANABE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	30MG/100ML (0.3MG/ML)	1	RADICAVA	EDARAVONE
002	SOLUTION;INTRAVENOUS	60MG/100ML (0.6MG/ML)	1	RADICAVA	EDARAVONE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2018-08-17	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2018-11-15	N/A
LABELING; Labeling	SUPPL	9	AP	2019-11-01	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-03-15	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-11-18	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	5	Orphan	5
SUPPL	9	Null	31
SUPPL	10	Null	15
SUPPL	12	Null	6

CDER Filings

MITSUBISHI TANABE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209176
            [companyName] => MITSUBISHI TANABE
            [docInserts] => ["",""]
            [products] => [{"drugName":"RADICAVA","activeIngredients":"EDARAVONE","strength":"30MG\/100ML (0.3MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"RADICAVA","activeIngredients":"EDARAVONE","strength":"60MG\/100ML (0.6MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/15\/2021","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209176s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209176s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209176s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2018","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209176Orig1s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209176lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/05\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209176lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209176Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209176Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/15\/2021","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209176s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209176Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"11\/01\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209176s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209176Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"11\/15\/2018","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209176Orig1s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209176Orig1s007ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209176Orig1s007.pdf\"}]","notes":">"},{"actionDate":"08\/17\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-03-15
        )

)