AZURITY Application 214679

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPRONTIA	TOPIRAMATE	SOLUTION; ORAL	15MG	No	No
002	EPRONTIA	TOPIRAMATE	SOLUTION; ORAL	25MG	No	No
003	EPRONTIA	TOPIRAMATE	SOLUTION; ORAL	50MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52652-9001	Eprontia	Topiramate	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-9001	Eprontia	Topiramate	Azurity Pharmaceuticals, Inc.	NDA	Current
52652-9001	Eprontia	Topiramate	Azurity Pharmaceuticals, Inc.	NDA	Current