Application 125409

Type: BLA
Sponsor: GENENTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERJETA	PERTUZUMAB	VIAL; SINGLE-USE	420MG/14ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-145	PERJETA	Pertuzumab	Genentech, Inc.	BLA	Current
50242-145	PERJETA	Pertuzumab	Genentech, Inc.	BLA	Current
50242-145	PERJETA	Pertuzumab	Genentech, Inc.	BLA	Current
50242-145	PERJETA	Pertuzumab	Genentech, Inc.	BLA	Current
50242-145	PERJETA	Pertuzumab	Genentech, Inc.	BLA	Current
50242-145	PERJETA	Pertuzumab	Genentech, Inc.	BLA	Current
50242-145	PERJETA	Pertuzumab	Genentech, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85759	SUPPL	2026-04-27
85749	SUPPL	2026-04-24
82731	SUPPL	2025-07-03
82703	SUPPL	2025-06-30
82193	SUPPL	2025-05-15
82189	SUPPL	2025-05-15
69509	SUPPL	2021-12-07
62283	SUPPL	2020-03-24
62278	SUPPL	2020-03-24
61597	SUPPL	2020-01-17
61587	SUPPL	2020-01-17
56924	SUPPL	2018-12-21
56904	SUPPL	2018-12-20
56003	SUPPL	2018-10-17
55731	SUPPL	2018-10-01
50890	SUPPL	2017-12-27
50889	SUPPL	2017-12-27
50795	SUPPL	2017-12-20
50794	SUPPL	2017-12-20
31962	SUPPL	2016-03-24
39954	SUPPL	2016-03-23
18910	SUPPL	2015-06-04
31961	SUPPL	2015-06-02
18909	SUPPL	2015-03-19
9742	SUPPL	2015-03-18
43328	SUPPL	2013-10-21
44806	SUPPL	2013-10-04
44566	SUPPL	2013-10-04
9741	SUPPL	2013-10-01
18908	SUPPL	2013-09-30
31960	SUPPL	2013-04-16
18907	SUPPL	2013-04-16
43327	ORIG	2012-07-30
24090	ORIG	2012-06-13
39953	ORIG	2012-06-11
9740	ORIG	2012-06-11