Application 203349

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	INJECTABLE;INTRAVENOUS	EQ 20MG BASE/VIAL	No	No
002	ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM	INJECTABLE;INTRAVENOUS	EQ 40MG BASE/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-451	Esomeprazole Sodium	Esomeprazole Sodium	Gland Pharma Limited	ANDA	Current
68083-451	Esomeprazole Sodium	Esomeprazole Sodium	Gland Pharma Limited	ANDA	Current
68083-451	Esomeprazole Sodium	Esomeprazole Sodium	Gland Pharma Limited	ANDA	Current
68083-452	Esomeprazole Sodium	Esomeprazole Sodium	Gland Pharma Limited	ANDA	Current
68083-452	Esomeprazole Sodium	Esomeprazole Sodium	Gland Pharma Limited	ANDA	Current
68083-452	Esomeprazole Sodium	Esomeprazole Sodium	Gland Pharma Limited	ANDA	Current