Application 125103

Type: BLA
Sponsor: BIOVITRUM AB

Related Records

Company: BIOVITRUM AB

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KEPIVANCE	PALIFERMIN	INJECTABLE; INJECTION	60MCG/KG/DAY	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66658-112	Kepivance	palifermin	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-112	Kepivance	palifermin	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-112	Kepivance	palifermin	Swedish Orphan Biovitrum AB (publ)	BLA	Current

Documents

Document	Submission type	Date
61387	SUPPL	2019-12-23
61342	SUPPL	2019-12-19
39836	SUPPL	2016-07-05
31829	SUPPL	2016-07-05
18784	SUPPL	2016-07-05
9601	SUPPL	2015-03-16
39835	SUPPL	2013-06-04
31828	SUPPL	2013-05-31
31827	SUPPL	2011-11-22
18783	SUPPL	2011-11-21
39834	SUPPL	2011-09-30
39833	SUPPL	2005-12-16
31826	SUPPL	2005-12-16
43304	ORIG	2005-09-26
23948	ORIG	2005-07-28
39832	ORIG	2004-12-29
31825	ORIG	2004-12-29
51456	ORIG	1900-01-01
51455	ORIG	1900-01-01