Application 761163

Type
BLA
Sponsor
MORPHOSYS US INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001Monjuvi (tafasitamab-cxix) for injectionTAFASITAMAB-CXIXINJECTABLE;INJECTION12MG/KGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73535-208MONJUVITafasitamab-cxixMorphoSys US Inc.BLACurrent
73535-208MONJUVITafasitamab-cxixMorphoSys US Inc.BLACurrent
73535-208MONJUVITafasitamab-cxixMorphoSys US Inc.BLACurrent
73535-208MONJUVITafasitamab-cxixMorphoSys US Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82626SUPPL 2025-06-20
82614SUPPL 2025-06-20
67688SUPPL2021-06-03
67681SUPPL2021-06-03
64439ORIG2020-08-27
64178ORIG2020-08-03
64162ORIG2020-07-31