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	2026-09-01

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PADCEV EJFV	ENFORTUMAB VEDOTIN	SEAGEN INC.	b5631d3e-4604-4363-8f20-11dfc5a4a8ed	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761137 ndc (product): 51144-030 ndc (product): 51144-020

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84281	SUPPL	2025-11-24
84288	SUPPL	2025-11-21
81386	SUPPL	2025-03-03
81382	SUPPL	2025-02-28
77066	SUPPL	2023-12-19
77065	SUPPL	2023-12-19
76864	SUPPL	2023-12-15
76863	SUPPL	2023-12-15
74027	SUPPL	2023-04-19
74026	SUPPL	2023-04-19
73960	SUPPL	2023-04-07
73949	SUPPL	2023-04-04
73948	SUPPL	2023-04-04
73941	SUPPL	2023-04-03
72521	SUPPL	2022-11-01
72508	SUPPL	2022-10-31
68056	SUPPL	2021-07-13
68055	SUPPL	2021-07-13
68039	SUPPL	2021-07-09
68038	SUPPL	2021-07-09
66868	SUPPL	2021-03-25
66838	SUPPL	2021-03-23
61536	ORIG	2020-01-08
61359	ORIG	2019-12-20
61344	ORIG	2019-12-19