Application 103780

Type: BLA
Sponsor: SERONO INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103780	Rebif	interferon beta-1a	351(a)	Rx	2026-08-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REBIF	INTERFERON BETA-1A	SYRINGE	22UG/0.5ML	No	No
002	REBIF	INTERFERON BETA-1A	SYRINGE	44UG/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
REBIF	INTERFERON BETA-1A	EMD Serono, Inc.	c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f	2025-09-22	Warnings, Adverse reactions	Exact identifier application number: BLA103780 ndc (product): 44087-0022 ndc (product): 44087-3344 ndc (product): 44087-8822 ndc (product): 44087-0188 ndc (product): 44087-0044 ndc (product): 44087-3322

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44087-0022	REBIF	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0022	REBIF	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0022	REBIF	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0022	REBIF	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0022	REBIF	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0022	REBIF	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0022	REBIF	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0022	REBIF	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0044	REBIF	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-0044	REBIF	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-0044	REBIF	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-0044	REBIF	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-0044	REBIF	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-0044	REBIF	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-0044	REBIF	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-0044	REBIF	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-0188	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0188	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0188	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0188	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0188	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0188	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0188	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-0188	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3322	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3322	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3322	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3322	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3322	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3322	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3322	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3322	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3344	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3344	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3344	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3344	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3344	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3344	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3344	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-3344	REBIF REBIDOSE	INTERFERON BETA-1A	EMD Serono, Inc.	BLA	Current
44087-8822	Rebif	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-8822	Rebif	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-8822	Rebif	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-8822	Rebif	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-8822	Rebif	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-8822	Rebif	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-8822	Rebif	interferon beta-1a	EMD Serono, Inc.	BLA	Current
44087-8822	Rebif	interferon beta-1a	EMD Serono, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74949	SUPPL	2023-07-31
74944	SUPPL	2023-07-31
74942	SUPPL	2023-07-31
69244	SUPPL	2021-11-05
69243	SUPPL	2021-11-05
69230	SUPPL	2021-11-05
65847	SUPPL	2021-01-07
63323	SUPPL	2020-05-28
63322	SUPPL	2020-05-28
63300	SUPPL	2020-05-27
63299	SUPPL	2020-05-27
63298	SUPPL	2020-05-27
63297	SUPPL	2020-05-27
59314	SUPPL	2019-07-11
59298	SUPPL	2019-07-10
45437	SUPPL	2016-09-30
45436	SUPPL	2016-09-30
39710	SUPPL	2015-12-28
9457	SUPPL	2015-12-23
18652	SUPPL	2015-03-12
31662	SUPPL	2015-03-11
39709	SUPPL	2014-04-28
39708	SUPPL	2014-04-28
31663	SUPPL	2014-04-25
9456	SUPPL	2014-04-25
9455	SUPPL	2013-04-24
39707	SUPPL	2013-04-23
39706	SUPPL	2012-12-28
31661	SUPPL	2012-12-28
31660	SUPPL	2005-07-21
18651	SUPPL	2005-07-21
31659	SUPPL	2005-01-26
31658	SUPPL	2005-01-26
18650	SUPPL	2005-01-26
18649	SUPPL	2005-01-26
39705	SUPPL	2004-03-26
31657	SUPPL	2004-03-26
22748	SUPPL	2004-03-26
43913	ORIG	2003-12-17
43284	ORIG	2003-12-17
18648	ORIG	2003-12-17
9454	ORIG	2003-12-17