Application 202686

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
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current
67457-392	Esomeprazole sodium	Esomeprazole sodium	Mylan Institutional LLC	ANDA	Current