Application 761137

Type
BLA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PADCEVENFORTUMAB VEDOTIN-EJFVINJECTABLE;INJECTION20MG/VIALNoNo
002PADCEVENFORTUMAB VEDOTIN-EJFVINJECTABLE;INJECTION30MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51144-020PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent
51144-020PADCEVENFORTUMAB VEDOTINSeattle Genetics, Inc.BLACurrent
51144-020PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent
51144-020PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent
51144-020PADCEVENFORTUMAB VEDOTINSeattle Genetics, Inc.BLACurrent
51144-020PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent
51144-020PADCEVENFORTUMAB VEDOTINSeattle Genetics, Inc.BLACurrent
51144-020PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent
51144-030PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent
51144-030PADCEVENFORTUMAB VEDOTINSeattle Genetics, Inc.BLACurrent
51144-030PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent
51144-030PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent
51144-030PADCEVENFORTUMAB VEDOTINSeattle Genetics, Inc.BLACurrent
51144-030PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent
51144-030PADCEVENFORTUMAB VEDOTINSeattle Genetics, Inc.BLACurrent
51144-030PADCEVENFORTUMAB VEDOTINSEAGEN INC.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84281SUPPL 2025-11-24
84288SUPPL 2025-11-21
81386SUPPL 2025-03-03
81382SUPPL 2025-02-28
77066SUPPL 2023-12-19
77065SUPPL 2023-12-19
76864SUPPL 2023-12-15
76863SUPPL 2023-12-15
74027SUPPL 2023-04-19
74026SUPPL 2023-04-19
73960SUPPL 2023-04-07
73949SUPPL 2023-04-04
73948SUPPL 2023-04-04
73941SUPPL 2023-04-03
72521SUPPL2022-11-01
72508SUPPL2022-10-31
68056SUPPL2021-07-13
68055SUPPL2021-07-13
68039SUPPL2021-07-09
68038SUPPL2021-07-09
66868SUPPL2021-03-25
66838SUPPL2021-03-23
61536ORIG2020-01-08
61359ORIG2019-12-20
61344ORIG2019-12-19