ACCORD HLTHCARE Application 205379

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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
16729-252	Esomeprazole sodium	Esomeprazole sodium	Accord Healthcare Inc.	ANDA	Current
16729-252	Esomeprazole sodium	Esomeprazole sodium	Accord Healthcare Inc.	ANDA	Current
16729-252	Esomeprazole sodium	Esomeprazole sodium	Accord Healthcare Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
19636	ORIG	2015-11-25
32663	ORIG	2015-10-02