Application 103951

Type: BLA
Sponsor: AMGEN

Related Records

Company: AMGEN

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARANESP	DARBEPOETIN ALFA	VIAL; INTRAVENOUS	25UG/ML	No	No
002	ARANESP	DARBEPOETIN ALFA	VIAL; INTRAVENOUS	40UG/ML	No	No
003	ARANESP	DARBEPOETIN ALFA	VIAL; INTRAVENOUS	60UG/ML	No	No
004	ARANESP	DARBEPOETIN ALFA	VIAL; INTRAVENOUS	100UG/ML	No	No
005	ARANESP	DARBEPOETIN ALFA	VIAL; INTRAVENOUS	200UG/ML	No	No
006	ARANESP	DARBEPOETIN ALFA	VIAL; SUBCUTANEOUS	25UG/ML	No	No
007	ARANESP	DARBEPOETIN ALFA	VIAL; SUBCUTANEOUS	40UG/ML	No	No
008	ARANESP	DARBEPOETIN ALFA	VIAL; SUBCUTANEOUS	60UG/ML	No	No
009	ARANESP	DARBEPOETIN ALFA	VIAL; SUBCUTANEOUS	100UG/ML	No	No
010	ARANESP	DARBEPOETIN ALFA	VIAL; SUBCUTANEOUS	200UG/ML	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55513-002	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-002	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-002	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-003	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-003	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-003	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-004	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-004	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-004	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-005	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-005	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-005	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-006	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-006	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-006	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-021	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-021	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-021	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-023	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-023	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-023	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-025	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-025	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-025	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-027	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-027	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-027	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-028	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-028	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-028	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-032	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-032	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-032	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-057	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-057	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-057	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-098	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-098	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-098	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-110	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-110	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-110	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-111	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-111	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current
55513-111	ARANESP	darbepoetin alfa	Amgen Inc	BLA	Current

Documents

Document	Submission type	Date
78338	SUPPL	2024-05-02
78331	SUPPL	2024-05-01
39760	SUPPL	2019-06-05
57583	SUPPL	2019-02-13
57388	SUPPL	2019-01-31
56981	SUPPL	2018-12-21
56980	SUPPL	2018-12-21
50308	SUPPL	2017-11-06
50247	SUPPL	2017-10-31
48043	SUPPL	2017-04-14
48014	SUPPL	2017-04-14
31742	SUPPL	2016-04-28
31741	SUPPL	2015-07-24
18710	SUPPL	2014-01-07
18709	SUPPL	2014-01-07
31739	SUPPL	2014-01-02
9517	SUPPL	2014-01-02
31740	SUPPL	2013-03-29
22765	SUPPL	2012-07-16
18708	SUPPL	2012-06-06
9516	SUPPL	2012-06-04
24355	SUPPL	2012-05-25
22764	SUPPL	2011-12-02
31738	SUPPL	2011-06-24
18707	SUPPL	2011-06-24
18705	SUPPL	2011-06-24
9515	SUPPL	2011-06-24
9514	SUPPL	2011-06-24
31735	SUPPL	2011-04-28
31736	SUPPL	2010-02-16
18706	SUPPL	2010-02-16
31737	SUPPL	2010-02-05
39758	SUPPL	2010-02-04
39757	SUPPL	2010-02-04
39756	SUPPL	2008-11-26
31734	SUPPL	2008-03-13
43576	SUPPL	2008-03-12
39755	SUPPL	2008-03-11
31733	SUPPL	2008-01-31
18704	SUPPL	2008-01-30
31732	SUPPL	2007-11-08
23082	SUPPL	2007-11-08
18703	SUPPL	2007-11-08
31730	SUPPL	2007-04-20
18701	SUPPL	2007-04-20
31731	SUPPL	2007-03-15
18702	SUPPL	2007-03-09
31729	SUPPL	2006-04-05
18700	SUPPL	2006-04-05
39754	SUPPL	2006-02-08
9512	SUPPL	2006-02-08
18699	SUPPL	2005-12-16
9513	SUPPL	2005-12-16
18698	SUPPL	2005-01-26
9511	SUPPL	2005-01-26
43575	SUPPL	2004-09-22
39753	SUPPL	2004-03-11
31728	SUPPL	2004-03-11
31727	ORIG	2004-01-21
22763	ORIG	2004-01-21
18697	ORIG	2004-01-21
52597	SUPPL	1900-01-01
52596	SUPPL	1900-01-01