Application 125499

Type: BLA
Sponsor: BIOGEN IDEC INC

Related Records

Company: BIOGEN IDEC INC

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLEGRIDY	PEGINTERFERON BETA-1A	INJECTABLE;INJECTION	125MICROGRAMS/0.5ML	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64406-011	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-011	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-011	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-011	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-011	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-011	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-011	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-011	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-011	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-012	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-012	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-012	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-012	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-012	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-012	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-012	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-012	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-015	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-015	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-015	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-015	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-015	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-015	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-015	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-015	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-015	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-016	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-016	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-016	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-016	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-016	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-016	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-016	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-016	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-017	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-017	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-017	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-017	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-017	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current
64406-017	Plegridy	peginterferon beta-1a	Biogen Inc.	BLA	Current

Documents

Document	Submission type	Date
74952	SUPPL	2023-07-31
74939	SUPPL	2023-07-31
74938	SUPPL	2023-07-31
70665	SUPPL	2022-03-31
70664	SUPPL	2022-03-31
70654	SUPPL	2022-03-30
69246	SUPPL	2021-11-05
69245	SUPPL	2021-11-05
69237	SUPPL	2021-11-05
66055	SUPPL	2021-02-02
66019	SUPPL	2021-01-29
66018	SUPPL	2021-01-29
62385	SUPPL	2020-03-31
62383	SUPPL	2020-03-31
62365	SUPPL	2020-03-30
59319	SUPPL	2019-07-12
59311	SUPPL	2019-07-11
39979	SUPPL	2016-07-18
31982	SUPPL	2016-07-15
18924	SUPPL	2015-12-28
31981	SUPPL	2015-12-23
43938	ORIG	2015-12-07
43333	ORIG	2014-09-17
24376	ORIG	2014-09-17
39978	ORIG	2014-08-18
31980	ORIG	2014-08-18