Application 205827

Type: NDA
Sponsor: AIR LIQUIDE AMERICA LP

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 21 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxygen	OXYGEN	AMO Medical Oxygen, Inc.	642ec89f-4ba3-68cd-e053-2991aa0a6a5c	2020-10-19		Name fallback generic name: OXYGEN
OXYGEN	OXYGEN	AIRSERVE, LLC	f7483c87-439b-4fe2-872e-ebb2b0d5cdbc	2019-12-18		Name fallback generic name: OXYGEN
Oxygen	OXYGEN	Air Products and Chemicals, Inc.	3d0d7bdd-28d9-43d4-827c-4f6f4df6a8bc	2016-08-11		Name fallback generic name: OXYGEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10671-010	OXYGEN	OXYGEN	Air Liquide America L.P.	NDA	Current
10671-011	OXYGEN	OXYGEN	Air Liquide America L.P.	NDA	Current
10671-013	OXYGEN	OXYGEN	Air Liquide America L.P.	NDA	Current
10671-100	EZ-OX	OXYGEN	Air Liquide America L.P.	NDA	Current
10671-101	EZ-OX Plus	EZ-OX Plus	Air Liquide America L.P.	NDA	Current
59713-001	Oxygen	Oxygen	Ann Arbor Welding Supply Co., Inc. DBA Arbor Specialty Gases	NDA	Current
59713-001	Oxygen	Oxygen	Ann Arbor Welding Supply Co., Inc. DBA Arbor Specialty Gases	NDA	Current
59713-001	Oxygen	Oxygen	Ann Arbor Welding Supply Co., Inc. DBA Arbor Specialty Gases	NDA	Current
59713-001	Oxygen	Oxygen	Ann Arbor Welding Supply Co., Inc. DBA Arbor Specialty Gases	NDA	Current
63045-001	Oxygen	Oxygen	Wyandotte Welding Supply Inc.	NDA	Current
67596-001	Oxygen	Oxygen	Compressed Gas Solutions Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32738	ORIG	2015-10-02