Application 761108

Type: BLA
Sponsor: ALEXION PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTOMIRIS	RAVULIZUMAB-CWVZ	INJECTABLE;INJECTION	300MG/30ML(10MG/ML)	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-022	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-025	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-025	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-025	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-025	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-025	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-025	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-025	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-028	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-028	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-028	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-028	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-028	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-028	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current
25682-028	Ultomiris	ravulizumab	Alexion Pharmaceuticals Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83600	SUPPL	2025-09-30
83583	SUPPL	2025-09-29
83582	SUPPL	2025-09-29
82693	SUPPL	2025-06-30
81421	SUPPL	2025-03-04
79669	SUPPL	2024-09-20
79664	SUPPL	2024-09-20
78966	SUPPL	2024-07-02
78949	SUPPL	2024-07-01
77955	SUPPL	2024-03-25
77954	SUPPL	2024-03-25
77949	SUPPL	2024-03-25
77948	SUPPL	2024-03-25
77448	SUPPL	2024-02-09
77440	SUPPL	2024-02-09
76273	ORIG	2023-11-03
71644	SUPPL	2022-07-27
71624	SUPPL	2022-07-25
71623	SUPPL	2022-07-25
70860	SUPPL	2022-04-29
70837	SUPPL	2022-04-27
70836	SUPPL	2022-04-27
69824	SUPPL	2022-01-11
69823	SUPPL	2022-01-10
69412	SUPPL	2021-11-24
67741	SUPPL	2021-06-08
67740	SUPPL	2021-06-08
67739	SUPPL	2021-06-08
67447	SUPPL	2021-05-10
67168	SUPPL	2021-04-23
64907	SUPPL	2020-10-14
64906	SUPPL	2020-10-14
64898	SUPPL	2020-10-14
62784	SUPPL	2020-05-01
60623	SUPPL	2019-10-22
60591	SUPPL	2019-10-18
60590	SUPPL	2019-10-18
57245	ORIG	2019-01-18
56976	ORIG	2018-12-21
56967	ORIG	2018-12-21
63241	SUPPL	1900-01-01