Application 202666

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	CAPSULE, DELAYED RELEASE;ORAL	30MG	No	No
002	DEXLANSOPRAZOLE	DEXLANSOPRAZOLE	CAPSULE, DELAYED RELEASE;ORAL	60MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24979-001	Dexlansoprazole	dexlansoprazole	TWI PHARMACEUTICALS, INC.	ANDA	Current
24979-002	Dexlansoprazole	dexlansoprazole	TWI PHARMACEUTICALS, INC.	ANDA	Current