Application 761029

Type: BLA
Sponsor: BIOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZINBRYTA	DACLIZUMAB	INJECTABLE;INJECTION	150MG/ML	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-0033	Zinbryta	Daclizumab	Abbvie	BLA	Current
0074-0034	Zinbryta	Daclizumab	Abbvie	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50322	SUPPL	2017-11-07
49640	SUPPL	2017-08-31
49639	SUPPL	2017-08-31
49584	SUPPL	2017-08-30
49583	SUPPL	2017-08-30
48602	SUPPL	2017-05-31
48575	SUPPL	2017-05-31
48574	SUPPL	2017-05-31
46809	ORIG	2017-01-13
24537	ORIG	2016-07-07
23055	ORIG	2016-07-07
20000	ORIG	2016-06-01
32915	ORIG	2016-05-31