FDA.reportPublic FDA data

Application 761065

Type
BLA
Sponsor
TAIMED BIOLOGICS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TROGARZOIBALIZUMAB-UIYKINJECTABLE;INJECTION150MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76783SUPPL 2023-12-13
76778SUPPL 2023-12-13
72266SUPPL2022-10-07
67171SUPPL2021-04-26
67167SUPPL2021-04-23
62659SUPPL2020-04-24
62609SUPPL2020-04-20
54394SUPPL2018-05-31
54387SUPPL2018-05-31
53561ORIG2018-03-30
52850ORIG2018-03-07
52849ORIG2018-03-07