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 4 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENJackson Welding Supply Co Inc.9bdff9a7-1ee7-4ee5-86f2-d30addd7530b2025-10-09Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENLife Supply Corp81b47e3d-1bfe-1174-e053-2a91aa0a61102025-10-07Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENCalifornia Tool and Welding Supply, LLC6584d696-7d32-4744-b225-03c52803e16a2025-10-06Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 14208-532
OxygenOXYGENButler Gas Products Companyad0ecc0f-f504-4409-942d-ac8b5988e4c62025-10-03Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 10189-001
OxygenOXYGENNew Bedford Welding Supply, Inc.608e9b5a-d296-4c66-8b1d-2f30ead877582025-10-02Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENBadger Welding Supplies, Inc.865454e8-ea25-4b6d-85c6-9db055eb31162025-07-07Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 12121-001
OXYGENOXYGENWelders Supply Company0b2529cf-3ec8-41b6-b5e6-68089c03fdb32025-07-06Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 11999-001
OxygenOXYGENACUTE CARE GAS LLC2796c936-048c-4867-9c8b-641c10bb89412025-06-27Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENYoungstown Oxygen & Welding Supply, Inc.26d2dd87-30e2-4859-8b4b-b8848184f8352024-10-29Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENWilson Products Compressed Gas Co.a7e6f9c2-7fb3-41bb-ac43-51b2268fbae32024-10-29Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENUnited States Welding, Inc.59765eb8-b22d-4514-b208-058b18727fc52024-10-29Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENStrate Welding Supply Co., Inc.2b49d5f8-c46a-48b6-a6a2-3fd05c5fe3192024-10-28Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENO.E. Meyer Companyfd0c6975-617c-4eb6-a19b-930d8ab830b32024-10-28Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENSeaboard Welding Supply, Inc.8fb1642b-da79-43a5-a458-e118b560512c2024-10-28Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENStrate Welding Supply Co., Inc.e2fbadf7-9e8c-4c56-a72e-f11563bfe4c62024-10-28Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENJW Welding Supplies & Toolsb21788c6-4f81-4f66-ac0b-54b3170c16f52024-10-27Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENKent Welding Supplybb0d9cf1-4229-4d10-91cd-16a71c8af7042024-10-27Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENIndiana Oxygen Company Inca116dc52-9522-4cc3-b745-0b0cc3e0d7dd2024-10-23Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENBronx Welding Supply Inc2d6e0678-e358-433b-a5fe-4e408210ee702024-10-08Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENAirweld, Inc.612ee482-2236-4641-b782-649f4969a90d2024-10-08Exact 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