Application 125513

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STRENSIQ	ASFOTASE ALFA	SOLUTION;INJECTION	18MG/0.45ML	No	No
002	STRENSIQ	ASFOTASE ALFA	SOLUTION;INJECTION	28MG/0.7ML	No	No
003	STRENSIQ	ASFOTASE ALFA	SOLUTION;INJECTION	40MG/ML	No	No
004	STRENSIQ	ASFOTASE ALFA	SOLUTION;INJECTION	80MG/0.8ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25682-010	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-010	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-010	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-010	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-013	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-013	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-013	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-013	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-016	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-016	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-016	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-016	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-019	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-019	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-019	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-019	STRENSIQ	ASFOTASE ALFA	Alexion Pharmaceuticals, Inc.	BLA	Current