Application 103172

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACTIVASE	ALTEPLASE	VIAL; SINGLE-USE	100MG/VIAL	No	No
002	ACTIVASE	ALTEPLASE	VIAL; SINGLE-USE	50MG/VIAL	No	No
003	CATHFLO ACTIVASE	ALTEPLASE	VIAL	2MG/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-041	Cathflo Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-041	Cathflo Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-041	Cathflo Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-041	Cathflo Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-041	Cathflo Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-044	Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-044	Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-044	Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-044	Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-085	Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-085	Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-085	Activase	Alteplase	Genentech, Inc.	BLA	Current
50242-085	Activase	Alteplase	Genentech, Inc.	BLA	Current