Application 125499

Type: BLA
Sponsor: BIOGEN IDEC INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125499	Plegridy	peginterferon beta-1a	351(a)	Rx	2026-07-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLEGRIDY	PEGINTERFERON BETA-1A	INJECTABLE;INJECTION	125MICROGRAMS/0.5ML	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
Plegridy Pen	PEGINTERFERON BETA-1A	Biogen Inc.	08f0ea03-4e6d-195d-aef4-886e32befa95	2025-11-12	Warnings, Adverse reactions	Exact identifier application number: BLA125499 ndc (product): 64406-015 ndc (product): 64406-011 ndc (product): 64406-016 ndc (product): 64406-012 ndc (product): 64406-017

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
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 table
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