Application 205767

Type
NDA
Sponsor
LINDE NORTH AMERICA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYGEN, USPOXYGENGAS;INHALATIONN/ANoNo

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 3 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYGENOXYGENJohnson Drug Company, Inc1b7bb66c-b4a2-48d9-a7df-373149da678c2025-11-21Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENMaine Oxy-Acetylene Supply Company9a3fbd92-ccad-4d2a-af12-10aaa48554402025-11-20Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENMID-SOUTH WELDING SUPPLY, INC.aae8e8ff-f579-462e-bbb7-7d710313890c2025-11-19Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENA&B Welding Supply, LLCd8141f47-efa8-1750-e053-2995a90a32ee2025-11-18Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENKeen Compressed Gas Co. Inc.aefa04b2-fce7-4ec1-bcb6-6cb76c32619b2025-11-17Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENSuperior Welding Supply Co8eae8423-fe05-46e1-9db9-d18d721bffde2025-11-14Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENBaker's Gas & Welding Supplies Inc.7f44d54e-4396-41a6-ae1f-c06efdaab1e52025-11-11Exact identifier
application applno (NDA): 205767
application number: NDA205767
AirAIRAndy-Oxy Co., Inc.60cc80bb-8fe9-fd31-e053-2991aa0a48952025-10-30Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENAndy-Oxy Co., Inc.265e287a-1dca-4f5b-98db-c98be97bc8112025-10-30Exact identifier
application applno (NDA): 205767
application number: NDA205767
AirAIREUGENE WELDERS SUPPLY CO9d0856fe-8789-4043-a938-9c368a5bf4b72025-10-29Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENEUGENE WELDERS SUPPLY CO0f044c9f-70b1-4d19-b61f-87ce2a00b8af2025-10-29Exact identifier
application applno (NDA): 205767
application number: NDA205767
CarbogenCARBOGENEUGENE WELDERS SUPPLY CO0c69e4ce-6fbe-cd62-e063-6394a90a9e432025-10-29Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENInstitutional Care Pharmacyd8a10c7b-ced0-457a-b793-80116cd965de2025-10-24Exact identifier
application applno (NDA): 205767
application number: NDA205767
AirAIRA-OX Welding Supply, LLCeadb1be6-f598-9124-e053-2995a90a441a2025-10-23Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 10297-103
HelioxHELIOXA-OX Welding Supply, LLCeadb2cba-9080-77e8-e053-2a95a90afe032025-10-23Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 10297-080
OxygenOXYGENA-OX Welding Supply, LLCd810b2ee-0e09-e952-e053-2a95a90afeca2025-10-23Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 10297-100
AirAIRAGL Welding Supply Co., Inc.614223a6-06e2-59b3-e053-2991aa0ac66d2025-10-22Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENAGL Inhalation Therapy Co.52bfd8c0-d181-4eef-90f5-d8bc9d1103fb2025-10-22Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 17575-001
OxygenOXYGENCRYOGENIC SOLUTIONS LLCbe603b41-f90d-6130-e053-2995a90af7df2025-10-20Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENWesco Gas & Welding Supply, Inc.b8114d53-aa6c-4abf-998e-9db86e4b43382025-10-13Exact identifier
application applno (NDA): 205767
application number: NDA205767

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10073-111oxygenoxygenOz Arc/gas Equipment & Supply, Inc.NDACurrent
10073-111oxygenoxygenOz Arc/gas Equipment & Supply, Inc.NDACurrent
10073-111oxygenoxygenOz Arc/gas Equipment & Supply, Inc.NDACurrent
10073-111oxygenoxygenOz Arc/gas Equipment & Supply, Inc.NDACurrent
10073-111oxygenoxygenOz Arc/gas Equipment & Supply, Inc.NDACurrent
10189-001OxygenOxygenButler Gas Products CompanyNDACurrent
10189-001OxygenOxygenButler Gas Products CompanyNDACurrent
10189-001OxygenOxygenButler Gas Products CompanyNDACurrent
10189-001OxygenOxygenButler Gas Products CompanyNDACurrent
10189-001OxygenOxygenButler Gas Products CompanyNDACurrent
10189-001OxygenOxygenButler Gas Products CompanyNDACurrent
10218-001OXYGENOXYGENCEE-KAY SUPPLY, INC.NDACurrent
10218-001OXYGENOXYGENCEE-KAY SUPPLY, INC.NDACurrent
10218-001OXYGENOXYGENCEE-KAY SUPPLY, INC.NDACurrent
10218-001OXYGENOXYGENCEE-KAY SUPPLY, INC.NDACurrent
10218-001OXYGENOXYGENCEE-KAY SUPPLY, INC.NDACurrent
10297-070HelioxHelioxA-OX WELDING SUPPLY CO., INC.NDACurrent
10297-080HelioxHelioxA-OX WELDING SUPPLY CO., INC.NDACurrent
10297-100OxygenOxygenA OX Welding Supply Company Inc.NDACurrent
10297-100OxygenOxygenA OX Welding Supply Company Inc.NDACurrent
10297-103AirAirA-OX Welding Supply Co., Inc.NDACurrent
10526-001OxygenOxygenHaun Welding Supply, Inc.NDACurrent
10526-005OxygenOxygenHaun Welding Supply, Inc.NDACurrent
10526-005OxygenOxygenHaun Welding Supply, Inc.NDACurrent
10526-005OxygenOxygenHaun Welding Supply, Inc.NDACurrent
10526-005OxygenOxygenHaun Welding Supply, Inc.NDACurrent
10526-005OxygenOxygenHaun Welding Supply, Inc.NDACurrent
10736-202OxygenOxygenMEDICAL-TECHNICAL GASES, INC.NDACurrent
10927-003OXYGENOXYGENPURITY CYLINDER GASES INCNDACurrent
10927-003OXYGENOXYGENPURITY CYLINDER GASES INCNDACurrent
10927-003OXYGENOXYGENPURITY CYLINDER GASES INCNDACurrent
10927-003OXYGENOXYGENPURITY CYLINDER GASES INCNDACurrent
10927-103OXYGENOXYGENPURITY CYLINDER GASES INCNDACurrent
10927-105OXYGENOXYGENPURITY CYLINDER GASES INCNDACurrent
11043-001OxygenOxygenS. J. Smith Co., Inc.NDACurrent
11043-001OxygenOxygenS. J. Smith Co., Inc.NDACurrent
11043-001OxygenOxygenS. J. Smith Co., Inc.NDACurrent
11043-001OxygenOxygenS. J. Smith Co., Inc.NDACurrent
11043-001OxygenOxygenS. J. Smith Co., Inc.NDACurrent
11999-001OXYGENOXYGENWelders Supply CompanyNDACurrent
11999-001OXYGENOXYGENWelders Supply CompanyNDACurrent
11999-001OXYGENOXYGENWelders Supply CompanyNDACurrent
11999-001OXYGENOXYGENWelders Supply CompanyNDACurrent
11999-001OXYGENOXYGENWelders Supply CompanyNDACurrent
11999-001OXYGENOXYGENWelders Supply CompanyNDACurrent
12121-001OXYGENOXYGENBadger Welding Supplies, IncNDACurrent
12121-001OXYGENOXYGENBadger Welding Supplies, IncNDACurrent
12121-001OXYGENOXYGENBadger Welding Supplies, IncNDACurrent
12121-001OXYGENOXYGENBadger Welding Supplies, IncNDACurrent
12121-001OXYGENOXYGENBadger Welding Supplies, IncNDACurrent
12121-001OXYGENOXYGENBadger Welding Supplies, IncNDACurrent
14208-532OXYGENOXYGENCalifornia Tool and Welding Supply, LLCNDACurrent
14208-532OXYGENOXYGENCalifornia Tool and Welding Supply, LLCNDACurrent
14208-532OXYGENOXYGENCalifornia Tool and Welding Supply, LLCNDACurrent
14208-532OXYGENOXYGENCalifornia Tool and Welding Supply, LLCNDACurrent
14208-532OXYGENOXYGENCalifornia Tool and Welding Supply, LLCNDACurrent
14208-532OXYGENOXYGENCalifornia Tool and Welding Supply, LLCNDACurrent
14961-001OxygenOxygenHaun Specialty Gases, Inc.NDACurrent
14961-004AirAirHaun Specialty Gases, Inc.NDACurrent
14961-004AirAirHaun Specialty Gases, Inc.NDACurrent
14961-004AirAirHaun Specialty Gases, Inc.NDACurrent
14961-004AirAirHaun Specialty Gases, Inc.NDACurrent
14961-004AirAirHaun Specialty Gases, Inc.NDACurrent
14961-006OxygenOxygenHaun Specialty Gases, Inc.NDACurrent
14961-006OxygenOxygenHaun Specialty Gases, Inc.NDACurrent
14961-006OxygenOxygenHaun Specialty Gases, Inc.NDACurrent
14961-006OxygenOxygenHaun Specialty Gases, Inc.NDACurrent
14961-006OxygenOxygenHaun Specialty Gases, Inc.NDACurrent
17575-001OxygenOxygenAGL Inhalation Therapy Co.NDACurrent
17575-001OxygenOxygenAGL Inhalation Therapy Co.NDACurrent
17575-001OxygenOxygenAGL Inhalation Therapy Co.NDACurrent
17575-001OxygenOxygenAGL Inhalation Therapy Co.NDACurrent
17575-001OxygenOxygenAGL Inhalation Therapy Co.NDACurrent
17575-020Carbon Dioxide Oxygen Mixture 5/95Carbon Dioxide Oxygen Mixture 5/95AGL Inhalation Therapy Co.NDACurrent
17575-020Carbon Dioxide Oxygen Mixture 5/95Carbon Dioxide Oxygen Mixture 5/95AGL Inhalation Therapy Co.NDACurrent
17575-020Carbon Dioxide Oxygen Mixture 5/95Carbon Dioxide Oxygen Mixture 5/95AGL Inhalation Therapy Co.NDACurrent
17575-020Carbon Dioxide Oxygen Mixture 5/95Carbon Dioxide Oxygen Mixture 5/95AGL Inhalation Therapy Co.NDACurrent
17575-020Carbon Dioxide Oxygen Mixture 5/95Carbon Dioxide Oxygen Mixture 5/95AGL Inhalation Therapy Co.NDACurrent
17575-038Oxygen Helium Mixture 30/70Oxygen Helium Mixture 30/70AGL Inhalation Therapy Co.NDACurrent
17575-038Oxygen Helium Mixture 30/70Oxygen Helium Mixture 30/70AGL Inhalation Therapy Co.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32719ORIG2015-10-02