Application 103780

Type: BLA
Sponsor: SERONO INC

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

NDC Listings For This Application#

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

Application 103780

Related Records#

Application Products#

NDC Listings For This Application#

Documents#