FDA.reportPublic FDA data

Application 215446

Type
NDA
Sponsor
MITSUBISHI TANABE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RADICAVA ORSEDARAVONESOLUTION;INTRAVENOUS105MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70510-2321RADICAVA ORSEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2321RADICAVA ORSEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2321RADICAVA ORSEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2321RADICAVA ORSEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2322RADICAVA ORSEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2322RADICAVA ORSEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2322RADICAVA ORSEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent
70510-2322RADICAVA ORSEDARAVONEMitsubishi Tanabe Pharma America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73712ORIG 2023-03-09
71075ORIG2022-05-16
71067ORIG2022-05-13