FDA.reportPublic FDA data

Application 125509

Type
BLA
Sponsor
ELUSYS THERAPEUTICS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANTHIMOBILTOXAXIMABINJECTABLE;INJECTION600MG/6MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69604-204AnthimobiltoxaximabElusys Therapeutics, Inc.BLACurrent
69604-204AnthimobiltoxaximabElusys Therapeutics, Inc.BLACurrent
69604-204AnthimobiltoxaximabElusys Therapeutics, Inc.BLACurrent
69604-204AnthimobiltoxaximabElusys Therapeutics, Inc.BLACurrent
69604-204AnthimobiltoxaximabElusys Therapeutics, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61118SUPPL2019-12-02
61104SUPPL2019-11-29
50211SUPPL2017-10-30
44811ORIG2016-04-26
43334ORIG2016-04-26
39980ORIG2016-03-28
31985ORIG2016-03-28
51417ORIG1900-01-01
51416ORIG1900-01-01
51415ORIG1900-01-01
51414ORIG1900-01-01
51413ORIG1900-01-01