Application 205767

Type: NDA
Sponsor: LINDE NORTH AMERICA INC

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 2 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oxygen	OXYGEN	Shaw Oxygen Company Inc	287f2a22-daea-4d64-80a7-2f825852c6a7	2025-12-02		Exact identifier application applno (NDA): 205767 application number: NDA205767
OXYGEN	OXYGEN	PURITY CYLINDER GASES INC	9af33c02-3ae7-29ae-e053-2a95a90ae547	2025-12-01		Exact identifier application applno (NDA): 205767 application number: NDA205767 ndc (product): 10927-003
Air	AIR	Minneapolis Oxygen Company	4a1097df-0eda-44e8-a2cb-c89a53fc2196	2025-12-01		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen	OXYGEN	Minneapolis Oxygen Company	71e087d2-b148-444d-b2d7-09a4cd3d228f	2025-12-01		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen	OXYGEN	James Oxygen and Supply Company	39d41dbb-c44c-4ef8-9de6-a4f36648f0cb	2025-11-26		Exact identifier application applno (NDA): 205767 application number: NDA205767
OXYGEN	OXYGEN	Lampton Welding Supply Company, Inc	d9acf863-acf3-4528-bb98-f616a1cef9b4	2025-11-26		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen	OXYGEN	T & C Flynn's Pharmacy Inc	2dde8f8b-8b4f-490e-ac52-5b47f91299ce	2025-11-26		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen	OXYGEN	County Welding Supply Co.	18a03db0-1ffd-4536-99a1-12e1cdd00b7c	2025-11-26		Exact identifier application applno (NDA): 205767 application number: NDA205767
Air	AIR	Westair Gases & Equipment, Inc.	60e0a8b9-1a9c-f98c-e053-2a91aa0ab1d3	2025-11-26		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen	OXYGEN	Westair Gases & Equipment, Inc.	899be502-55ba-4795-9e75-78951d6e7aeb	2025-11-26		Exact identifier application applno (NDA): 205767 application number: NDA205767
Carbogen	CARBOGEN	Westair Gases & Equipment, Inc.	60e0fb73-0329-5e30-e053-2a91aa0ae779	2025-11-26		Exact identifier application applno (NDA): 205767 application number: NDA205767
OXYGEN	OXYGEN	Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply	895518e1-0912-0fb0-e053-2995a90a40c6	2025-11-26		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen	OXYGEN	Young Welding Supply, Inc	b192ed5e-f641-7b31-e053-2a95a90a0dde	2025-11-26		Exact identifier application applno (NDA): 205767 application number: NDA205767
Air	AIR	Dale Oxygen And Acetylene Service, Inc	4b45f833-b33c-4518-a755-86fa887953a7	2025-11-25		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen	OXYGEN	Dale Oxygen And Acetylene Service, Inc	43d1f68d-874b-4cbc-94ff-fd498cc9f2c1	2025-11-25		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen Carbon Dioxide	OXYGEN CARBON DIOXIDE	MEDICAL-TECHNICAL GASES, INC.	1d72e61f-f9b4-3d01-e063-6394a90ab1f9	2025-11-25		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen	OXYGEN	MEDICAL-TECHNICAL GASES, INC.	eb3ce21e-e605-6260-e053-2a95a90a75e1	2025-11-25		Exact identifier application applno (NDA): 205767 application number: NDA205767 ndc (product): 10736-202
oxygen	OXYGEN	A & E Mill & Welding Supply Company	feb9f3f3-f910-4936-8cde-60e1b8cf76bc	2025-11-25		Exact identifier application applno (NDA): 205767 application number: NDA205767
Oxygen	OXYGEN	S. J. Smith Co., Inc.	89544705-5d9d-4595-8870-fa46c9c14af2	2025-11-25		Exact identifier application applno (NDA): 205767 application number: NDA205767 ndc (product): 11043-001
oxygen	OXYGEN	Oz Arc/gas Equipment & Supply, Inc.	78b4bb26-f66a-4f5a-801b-d42637ff294b	2025-11-21		Exact identifier application applno (NDA): 205767 application number: NDA205767 ndc (product): 10073-111

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 6 · 470 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10073-111	oxygen	oxygen	Oz Arc/gas Equipment & Supply, Inc.	NDA	Current
10073-111	oxygen	oxygen	Oz Arc/gas Equipment & Supply, Inc.	NDA	Current
10073-111	oxygen	oxygen	Oz Arc/gas Equipment & Supply, Inc.	NDA	Current
10073-111	oxygen	oxygen	Oz Arc/gas Equipment & Supply, Inc.	NDA	Current
10073-111	oxygen	oxygen	Oz Arc/gas Equipment & Supply, Inc.	NDA	Current
10189-001	Oxygen	Oxygen	Butler Gas Products Company	NDA	Current
10189-001	Oxygen	Oxygen	Butler Gas Products Company	NDA	Current
10189-001	Oxygen	Oxygen	Butler Gas Products Company	NDA	Current
10189-001	Oxygen	Oxygen	Butler Gas Products Company	NDA	Current
10189-001	Oxygen	Oxygen	Butler Gas Products Company	NDA	Current
10189-001	Oxygen	Oxygen	Butler Gas Products Company	NDA	Current
10218-001	OXYGEN	OXYGEN	CEE-KAY SUPPLY, INC.	NDA	Current
10218-001	OXYGEN	OXYGEN	CEE-KAY SUPPLY, INC.	NDA	Current
10218-001	OXYGEN	OXYGEN	CEE-KAY SUPPLY, INC.	NDA	Current
10218-001	OXYGEN	OXYGEN	CEE-KAY SUPPLY, INC.	NDA	Current
10218-001	OXYGEN	OXYGEN	CEE-KAY SUPPLY, INC.	NDA	Current
10297-070	Heliox	Heliox	A-OX WELDING SUPPLY CO., INC.	NDA	Current
10297-080	Heliox	Heliox	A-OX WELDING SUPPLY CO., INC.	NDA	Current
10297-100	Oxygen	Oxygen	A OX Welding Supply Company Inc.	NDA	Current
10297-100	Oxygen	Oxygen	A OX Welding Supply Company Inc.	NDA	Current
10297-103	Air	Air	A-OX Welding Supply Co., Inc.	NDA	Current
10526-001	Oxygen	Oxygen	Haun Welding Supply, Inc.	NDA	Current
10526-005	Oxygen	Oxygen	Haun Welding Supply, Inc.	NDA	Current
10526-005	Oxygen	Oxygen	Haun Welding Supply, Inc.	NDA	Current
10526-005	Oxygen	Oxygen	Haun Welding Supply, Inc.	NDA	Current
10526-005	Oxygen	Oxygen	Haun Welding Supply, Inc.	NDA	Current
10526-005	Oxygen	Oxygen	Haun Welding Supply, Inc.	NDA	Current
10736-202	Oxygen	Oxygen	MEDICAL-TECHNICAL GASES, INC.	NDA	Current
10927-003	OXYGEN	OXYGEN	PURITY CYLINDER GASES INC	NDA	Current
10927-003	OXYGEN	OXYGEN	PURITY CYLINDER GASES INC	NDA	Current
10927-003	OXYGEN	OXYGEN	PURITY CYLINDER GASES INC	NDA	Current
10927-003	OXYGEN	OXYGEN	PURITY CYLINDER GASES INC	NDA	Current
10927-103	OXYGEN	OXYGEN	PURITY CYLINDER GASES INC	NDA	Current
10927-105	OXYGEN	OXYGEN	PURITY CYLINDER GASES INC	NDA	Current
11043-001	Oxygen	Oxygen	S. J. Smith Co., Inc.	NDA	Current
11043-001	Oxygen	Oxygen	S. J. Smith Co., Inc.	NDA	Current
11043-001	Oxygen	Oxygen	S. J. Smith Co., Inc.	NDA	Current
11043-001	Oxygen	Oxygen	S. J. Smith Co., Inc.	NDA	Current
11043-001	Oxygen	Oxygen	S. J. Smith Co., Inc.	NDA	Current
11999-001	OXYGEN	OXYGEN	Welders Supply Company	NDA	Current
11999-001	OXYGEN	OXYGEN	Welders Supply Company	NDA	Current
11999-001	OXYGEN	OXYGEN	Welders Supply Company	NDA	Current
11999-001	OXYGEN	OXYGEN	Welders Supply Company	NDA	Current
11999-001	OXYGEN	OXYGEN	Welders Supply Company	NDA	Current
11999-001	OXYGEN	OXYGEN	Welders Supply Company	NDA	Current
12121-001	OXYGEN	OXYGEN	Badger Welding Supplies, Inc	NDA	Current
12121-001	OXYGEN	OXYGEN	Badger Welding Supplies, Inc	NDA	Current
12121-001	OXYGEN	OXYGEN	Badger Welding Supplies, Inc	NDA	Current
12121-001	OXYGEN	OXYGEN	Badger Welding Supplies, Inc	NDA	Current
12121-001	OXYGEN	OXYGEN	Badger Welding Supplies, Inc	NDA	Current
12121-001	OXYGEN	OXYGEN	Badger Welding Supplies, Inc	NDA	Current
14208-532	OXYGEN	OXYGEN	California Tool and Welding Supply, LLC	NDA	Current
14208-532	OXYGEN	OXYGEN	California Tool and Welding Supply, LLC	NDA	Current
14208-532	OXYGEN	OXYGEN	California Tool and Welding Supply, LLC	NDA	Current
14208-532	OXYGEN	OXYGEN	California Tool and Welding Supply, LLC	NDA	Current
14208-532	OXYGEN	OXYGEN	California Tool and Welding Supply, LLC	NDA	Current
14208-532	OXYGEN	OXYGEN	California Tool and Welding Supply, LLC	NDA	Current
14961-001	Oxygen	Oxygen	Haun Specialty Gases, Inc.	NDA	Current
14961-004	Air	Air	Haun Specialty Gases, Inc.	NDA	Current
14961-004	Air	Air	Haun Specialty Gases, Inc.	NDA	Current
14961-004	Air	Air	Haun Specialty Gases, Inc.	NDA	Current
14961-004	Air	Air	Haun Specialty Gases, Inc.	NDA	Current
14961-004	Air	Air	Haun Specialty Gases, Inc.	NDA	Current
14961-006	Oxygen	Oxygen	Haun Specialty Gases, Inc.	NDA	Current
14961-006	Oxygen	Oxygen	Haun Specialty Gases, Inc.	NDA	Current
14961-006	Oxygen	Oxygen	Haun Specialty Gases, Inc.	NDA	Current
14961-006	Oxygen	Oxygen	Haun Specialty Gases, Inc.	NDA	Current
14961-006	Oxygen	Oxygen	Haun Specialty Gases, Inc.	NDA	Current
17575-001	Oxygen	Oxygen	AGL Inhalation Therapy Co.	NDA	Current
17575-001	Oxygen	Oxygen	AGL Inhalation Therapy Co.	NDA	Current
17575-001	Oxygen	Oxygen	AGL Inhalation Therapy Co.	NDA	Current
17575-001	Oxygen	Oxygen	AGL Inhalation Therapy Co.	NDA	Current
17575-001	Oxygen	Oxygen	AGL Inhalation Therapy Co.	NDA	Current
17575-020	Carbon Dioxide Oxygen Mixture 5/95	Carbon Dioxide Oxygen Mixture 5/95	AGL Inhalation Therapy Co.	NDA	Current
17575-020	Carbon Dioxide Oxygen Mixture 5/95	Carbon Dioxide Oxygen Mixture 5/95	AGL Inhalation Therapy Co.	NDA	Current
17575-020	Carbon Dioxide Oxygen Mixture 5/95	Carbon Dioxide Oxygen Mixture 5/95	AGL Inhalation Therapy Co.	NDA	Current
17575-020	Carbon Dioxide Oxygen Mixture 5/95	Carbon Dioxide Oxygen Mixture 5/95	AGL Inhalation Therapy Co.	NDA	Current
17575-020	Carbon Dioxide Oxygen Mixture 5/95	Carbon Dioxide Oxygen Mixture 5/95	AGL Inhalation Therapy Co.	NDA	Current
17575-038	Oxygen Helium Mixture 30/70	Oxygen Helium Mixture 30/70	AGL Inhalation Therapy Co.	NDA	Current
17575-038	Oxygen Helium Mixture 30/70	Oxygen Helium Mixture 30/70	AGL Inhalation Therapy Co.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32719	ORIG	2015-10-02