Home Applications 761137 Application 761137
Type BLA
Sponsor ASTELLAS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761137 Padcev enfortumab vedotin-ejfv 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PADCEV ENFORTUMAB VEDOTIN-EJFV INJECTABLE;INJECTION 20MG/VIAL No No 002 PADCEV ENFORTUMAB VEDOTIN-EJFV INJECTABLE;INJECTION 30MG/VIAL No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51144-020 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current 51144-020 PADCEV ENFORTUMAB VEDOTIN Seattle Genetics, Inc. BLA Current 51144-020 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current 51144-020 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current 51144-020 PADCEV ENFORTUMAB VEDOTIN Seattle Genetics, Inc. BLA Current 51144-020 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current 51144-020 PADCEV ENFORTUMAB VEDOTIN Seattle Genetics, Inc. BLA Current 51144-020 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current 51144-030 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current 51144-030 PADCEV ENFORTUMAB VEDOTIN Seattle Genetics, Inc. BLA Current 51144-030 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current 51144-030 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current 51144-030 PADCEV ENFORTUMAB VEDOTIN Seattle Genetics, Inc. BLA Current 51144-030 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current 51144-030 PADCEV ENFORTUMAB VEDOTIN Seattle Genetics, Inc. BLA Current 51144-030 PADCEV ENFORTUMAB VEDOTIN SEAGEN INC. BLA Current