Application 205851

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HELIUM, USP	HELIUM	GAS;INHALATION	N/A	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
12213-710	Helium	Helium	NexAir, LLC	NDA	Current
12213-710	Helium	Helium	NexAir, LLC	NDA	Current
12213-710	Helium	Helium	NexAir, LLC	NDA	Current
12213-710	Helium	Helium	NexAir, LLC	NDA	Current
12213-710	Helium	Helium	NexAir, LLC	NDA	Current
12213-710	Helium	Helium	NexAir, LLC	NDA	Current
17575-005	Helium	Helium	AGL Inhalation Therapy Co.	NDA	Current
49575-020	Helium	Helium	Machine & Welding Supply Company dba Arc3 Gases South	NDA	Current
49575-020	Helium	Helium	Machine & Welding Supply Company dba Arc3 Gases South	NDA	Current
59579-009	Helium Oxygen mixture	Helium Oxygen mixture	Praxair Distribution, Inc.	NDA AUTHORIZED GENERIC	Current
59579-009	Helium Oxygen mixture	Helium Oxygen mixture	Praxair Distribution, Inc.	NDA AUTHORIZED GENERIC	Current
59579-009	Helium Oxygen mixture	Helium Oxygen mixture	Praxair Distribution, Inc.	NDA AUTHORIZED GENERIC	Current
59579-009	Helium Oxygen mixture	Helium Oxygen mixture	Praxair Distribution, Inc.	NDA AUTHORIZED GENERIC	Current
59579-010	Helium Oxygen Nitrogen mixture	Helium Oxygen Nitrogen mixture	Praxair Distribution, Inc.	NDA AUTHORIZED GENERIC	Current
59579-010	Helium Oxygen Nitrogen mixture	Helium Oxygen Nitrogen mixture	Praxair Distribution, Inc.	NDA AUTHORIZED GENERIC	Current
59579-010	Helium Oxygen Nitrogen mixture	Helium Oxygen Nitrogen mixture	Praxair Distribution, Inc.	NDA AUTHORIZED GENERIC	Current
59579-010	Helium Oxygen Nitrogen mixture	Helium Oxygen Nitrogen mixture	Praxair Distribution, Inc.	NDA AUTHORIZED GENERIC	Current

Document, Submission type, Date table
Document	Submission type	Date
32755	ORIG	2015-09-30