FDA.reportPublic FDA data

Application 209176

Type
NDA
Sponsor
MITSUBISHI TANABE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RADICAVAEDARAVONESOLUTION;INTRAVENOUS30MG/100ML (0.3MG/ML)YesYes
002RADICAVAEDARAVONESOLUTION;INTRAVENOUS60MG/100ML (0.6MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70510-2171RADICAVAEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAedaravoneMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAedaravoneMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAedaravoneMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAedaravoneMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAedaravoneMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAedaravoneMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2171RADICAVAedaravoneMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2172RADICAVAedaravoneMitsubishi Tanabe Pharma America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72669SUPPL2022-11-22
72656SUPPL2022-11-20
66797SUPPL2021-03-17
66791SUPPL2021-03-16
60782SUPPL2019-11-05
60779SUPPL2019-11-05
59619SUPPL2019-08-07
59012SUPPL2019-06-11
58338SUPPL2019-04-15
48785ORIG2017-06-20
48297ORIG2017-05-09
48276ORIG2017-05-08