Application 125388

Type: BLA
Sponsor: SEATTLE GENETICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADCETRIS	BRENTUXIMAB VEDOTIN	INJECTABLE; INJECTION	50MG/VIAL	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51144-050	ADCETRIS	brentuximab vedotin	SEAGEN INC.	BLA	Current
51144-050	ADCETRIS	brentuximab vedotin	Seattle Genetics, Inc.	BLA	Current
51144-050	ADCETRIS	brentuximab vedotin	Seattle Genetics, Inc.	BLA	Current
51144-050	ADCETRIS	brentuximab vedotin	SEAGEN INC.	BLA	Current
51144-050	ADCETRIS	brentuximab vedotin	SEAGEN INC.	BLA	Current
51144-050	ADCETRIS	brentuximab vedotin	SEAGEN INC.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81222	SUPPL	2025-02-12
81217	SUPPL	2025-02-12
74644	SUPPL	2023-06-28
74498	SUPPL	2023-06-15
74490	SUPPL	2023-06-15
72609	SUPPL	2022-11-14
72599	SUPPL	2022-11-13
60581	SUPPL	2019-10-24
60573	SUPPL	2019-10-16
56524	SUPPL	2018-11-20
56505	SUPPL	2018-11-19
53494	SUPPL	2018-03-28
53068	SUPPL	2018-03-20
50367	SUPPL	2017-11-13
50348	SUPPL	2017-11-09
47285	SUPPL	2017-02-22
45497	SUPPL	2016-09-30
39951	SUPPL	2016-03-08
31955	SUPPL	2016-03-08
39950	SUPPL	2015-08-17
31954	SUPPL	2015-08-17
18902	SUPPL	2015-08-17
9738	SUPPL	2015-08-17
31953	SUPPL	2014-11-26
9737	SUPPL	2014-11-26
18901	SUPPL	2014-11-25
18900	SUPPL	2014-11-25
9736	SUPPL	2013-08-22
39949	SUPPL	2013-08-21
44429	ORIG	2012-02-13
31952	SUPPL	2012-01-19
18899	SUPPL	2012-01-13
43325	ORIG	2011-10-03
24367	ORIG	2011-10-03
39948	ORIG	2011-08-19
31951	ORIG	2011-08-19