NAVINTA LLC Application 206561

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOMETHACIN SODIUM	INDOMETHACIN SODIUM	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-470	INDOMETHACIN	INDOMETHACIN	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-470	INDOMETHACIN	INDOMETHACIN	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-470	INDOMETHACIN	INDOMETHACIN	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-470	INDOMETHACIN	INDOMETHACIN	Zydus Pharmaceuticals USA Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
49083	ORIG	2017-07-26
49035	ORIG	2017-07-21