FDA.reportPublic FDA data

Application 761104

Type
BLA
Sponsor
ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUMOXITIMOXETUMOMAB PASUDOTOX-TDFKINJECTABLE;INJECTION1MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-4700LUMOXITImoxetumomab pasudotoxAstraZeneca Pharmaceuticals LPBLACurrent
0310-4700LUMOXITImoxetumomab pasudotoxAstraZeneca Pharmaceuticals LPBLACurrent
0310-4700LUMOXITImoxetumomab pasudotoxAstraZeneca Pharmaceuticals LPBLACurrent
0310-4700LUMOXITImoxetumomab pasudotoxAstraZeneca Pharmaceuticals LPBLACurrent
0310-4700LUMOXITImoxetumomab pasudotoxAstraZeneca Pharmaceuticals LPBLACurrent
0310-4715IV Solution StabilizerIV Solution StabilizerAstraZeneca Pharmaceuticals LPBLACurrent
0310-4715IV Solution StabilizerIV Solution StabilizerAstraZeneca Pharmaceuticals LPBLACurrent
0310-4715IV Solution StabilizerIV Solution StabilizerAstraZeneca Pharmaceuticals LPBLACurrent
0310-4715IV Solution StabilizerIV Solution StabilizerAstraZeneca Pharmaceuticals LPBLACurrent
0310-4715IV Solution StabilizerIV Solution StabilizerAstraZeneca Pharmaceuticals LPBLACurrent
73380-4700LUMOXITIMOXETUMOMAB PASUDOTOXInnate Pharma, Inc.BLACurrent
73380-4700LUMOXITIMOXETUMOMAB PASUDOTOXInnate Pharma, Inc.BLACurrent
73380-4715IV STABILIZERPOLYSORBATE 80Innate Pharma, Inc.BLACurrent
73380-4715IV STABILIZERPOLYSORBATE 80Innate Pharma, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64376SUPPL2020-08-24
64347SUPPL2020-08-21
64346SUPPL2020-08-21
57552SUPPL2019-02-13
57369SUPPL2019-01-29
57368SUPPL2019-01-29
55873ORIG2018-10-11
55487ORIG2018-09-14
55476ORIG2018-09-13
55475ORIG2018-09-13