FDA.reportPublic FDA data

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 1 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENAtlas Welding Supply Company, Inc.85c52db3-ce42-4306-9bf3-451b56bbba822026-07-15Exact identifier
application applno (NDA): 205767
application number: NDA205767
AirAIRMaine Oxy-Acetylene Supply Company03140c87-86d2-4753-abd1-737e50c9041e2026-06-18Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENGulf Coast Gas & Equipment, LLC374cdd84-3d25-28b3-e063-6394a90a9f242026-05-28Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENMesser LLC0de4fe56-80c8-06be-da02-b145e0a5dbf22026-04-13Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENMachine & Welding Supply Company dba Arc3 Gases South08936fbe-b98b-4a97-a99b-3e06caa15aaf2026-03-04Exact identifier
application applno (NDA): 205767
application number: NDA205767
OXYGENOXYGENCEE-KAY SUPPLY, INC.7a4aa7ab-08a4-4e93-90d7-5329b0e1a61b2026-02-25Exact identifier
application applno (NDA): 205767
application number: NDA205767
Oxygen Helium Mixture 30/70OXYGEN HELIUM MIXTURE 30/70AGL Inhalation Therapy Co.3c799e75-d974-4f9d-bd47-0ffbd05b8b982026-01-01Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 17575-038
Oxygen Helium Mixture 20/80OXYGEN HELIUM MIXTURE 20/80AGL Inhalation Therapy Co.e5f7f27b-5c9d-47f3-8312-641cb8b3ffd12026-01-01Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 17575-192
Carbon Dioxide Oxygen Mixture 5/95CARBON DIOXIDE OXYGEN MIXTURE 5/95AGL Inhalation Therapy Co.a5a3db93-de47-4685-9c20-dbf0ff30047a2026-01-01Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENHaun Welding Supply, Inc.97ccccd8-4da5-f521-e053-2a95a90a0faf2025-12-29Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENHaun Specialty Gases, Inc.97cc950c-ea97-c25b-e053-2995a90a16c62025-12-29Exact identifier
application applno (NDA): 205767
application number: NDA205767
AirAIRHaun Specialty Gases, Inc.7e4b94e3-b4fb-4968-bfce-9ad508eea78b2025-12-29Exact identifier
application applno (NDA): 205767
application number: NDA205767
AirAIR- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.d85840d6-c7ea-4a52-81a0-feaf43c2a0e52025-12-19Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 42241-003
OxygenOXYGENWEST PENN LACO, INC.bd2023e7-da7d-7777-e053-2995a90aa64f2025-12-09Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENGas and Supply Carolinas, LLC05a73ef4-f9ba-f4fc-e063-6294a90a83212025-12-08Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGEN- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.469e1310-0fa3-4481-a1be-cd8889c4abc12025-12-08Exact identifier
application applno (NDA): 205767
application number: NDA205767
ndc (product): 42241-001
OxygenOXYGENJayco Industrial Supply Inc8d86f28c-3bab-4728-ad92-e8e9f779f3862025-12-08Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENSouthern Gas and Supply LLC8a9b0cb5-3236-4de4-a97d-eb247c6c7c682025-12-08Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENSouthern Gas and Supply of Mississippi, Inc.1951ddf8-0a94-4678-8ade-198fe356703a2025-12-08Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENSOUTHERN GAS AND SUPPLY, INC. dba Gas and Supply9af03e06-8add-2b72-e053-2995a90ab8292025-12-08Exact 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 2 of 6 · 470 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
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
17575-038Oxygen Helium Mixture 30/70Oxygen Helium Mixture 30/70AGL Inhalation Therapy Co.NDACurrent
17575-192Oxygen Helium Mixture 20/80Oxygen Helium Mixture 20/80AGL Inhalation Therapy Co.NDACurrent
17575-192Oxygen Helium Mixture 20/80Oxygen Helium Mixture 20/80AGL Inhalation Therapy Co.NDACurrent
17575-192Oxygen Helium Mixture 20/80Oxygen Helium Mixture 20/80AGL Inhalation Therapy Co.NDACurrent
17575-192Oxygen Helium Mixture 20/80Oxygen Helium Mixture 20/80AGL Inhalation Therapy Co.NDACurrent
17575-192Oxygen Helium Mixture 20/80Oxygen Helium Mixture 20/80AGL Inhalation Therapy Co.NDACurrent
17575-300AirAirAGL Welding Supply Co., Inc.NDACurrent
17575-300AirAirAGL Welding Supply Co., Inc.NDACurrent
17575-300AirAirAGL Welding Supply Co., Inc.NDACurrent
17575-300AirAirAGL Welding Supply Co., Inc.NDACurrent
17575-300AirAirAGL Welding Supply Co., Inc.NDACurrent
17819-1072OXYGENOXYGENNoble Gas Solutions, Inc.NDACurrent
17819-1072OXYGENOXYGENNoble Gas Solutions, Inc.NDACurrent
17819-1072OXYGENOXYGENNoble Gas Solutions, Inc.NDACurrent
17819-1072OXYGENOXYGENNoble Gas Solutions, Inc.NDACurrent
23650-001OxygenOxygenNew Bedford Welding Supply, Inc.NDACurrent
23650-001OxygenOxygenNew Bedford Welding Supply, Inc.NDACurrent
23650-001OxygenOxygenNew Bedford Welding Supply, Inc.NDACurrent
23650-001OxygenOxygenNew Bedford Welding Supply, Inc.NDACurrent
23650-001OxygenOxygenNew Bedford Welding Supply, Inc.NDACurrent
33335-001OxygenOxygenWELSCO, INC.NDACurrent
33335-001OxygenOxygenWELSCO, INC.NDACurrent
33335-001OxygenOxygenWELSCO, INC.NDACurrent
33335-001OxygenOxygenWELSCO, INC.NDACurrent
42068-001OxygenOxygenJackson Welding Supply Co Inc.NDACurrent
42068-001OxygenOxygenJackson Welding Supply Co Inc.NDACurrent
42068-001OxygenOxygenJackson Welding Supply Co Inc.NDACurrent
42068-001OxygenOxygenJackson Welding Supply Co Inc.NDACurrent
42068-001OxygenOxygenJackson Welding Supply Co Inc.NDACurrent
42139-001OXYGENOXYGENSeaboard Welding Supply Co., Inc.NDACurrent
42139-001OXYGENOXYGENSeaboard Welding Supply Co., Inc.NDACurrent
42139-001OXYGENOXYGENSeaboard Welding Supply Co., Inc.NDACurrent
42139-001OXYGENOXYGENSeaboard Welding Supply Co., Inc.NDACurrent
42139-001OXYGENOXYGENSeaboard Welding Supply Co., Inc.NDACurrent
42241-001OxygenOxygen- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-001OxygenOxygen- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-001OxygenOxygen- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-001OxygenOxygen- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-001OxygenOxygen- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-003AirAir- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-003AirAir- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-003AirAir- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-003AirAir- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42241-003AirAir- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.NDACurrent
42821-001OxygenOxygenT & C Flynn's Pharmacy IncNDACurrent
42821-001OxygenOxygenT & C Flynn's Pharmacy IncNDACurrent
42821-001OxygenOxygenT & C Flynn's Pharmacy IncNDACurrent
42821-001OxygenOxygenT & C Flynn's Pharmacy IncNDACurrent
42821-001OxygenOxygenT & C Flynn's Pharmacy IncNDACurrent
44363-1815OXYGENOXYGENInstitutional Care PharmacyNDACurrent
44363-1815OXYGENOXYGENInstitutional Care PharmacyNDACurrent
44363-1815OXYGENOXYGENInstitutional Care PharmacyNDACurrent
44363-1815OXYGENOXYGENInstitutional Care PharmacyNDACurrent
44363-1815OXYGENOXYGENInstitutional Care PharmacyNDACurrent
47285-291OxygenOxygenJames C. Dawes Company, IncNDACurrent
47285-291OxygenOxygenJames C. Dawes Company, IncNDACurrent
47285-291OxygenOxygenJames C. Dawes Company, IncNDACurrent
47285-291OxygenOxygenJames C. Dawes Company, IncNDACurrent
47632-0029OXYGENOXYGENO.E. Meyer CompanyNDACurrent
47632-0029OXYGENOXYGENO.E. Meyer CompanyNDACurrent
47632-0029OXYGENOXYGENO.E. Meyer CompanyNDACurrent
47632-0029OXYGENOXYGENO.E. Meyer CompanyNDACurrent
47632-0029OXYGENOXYGENO.E. Meyer CompanyNDACurrent
47632-0030OXYGENOXYGENO.E. Meyer CompanyNDACurrent
47632-0030OXYGENOXYGENO.E. Meyer CompanyNDACurrent
47632-0030OXYGENOXYGENO.E. Meyer CompanyNDACurrent
47632-0030OXYGENOXYGENO.E. Meyer CompanyNDACurrent
47632-0030OXYGENOXYGENO.E. Meyer CompanyNDACurrent
48273-001OXYGENOXYGENKeen Compressed Gas Co. Inc.NDACurrent
48273-001OXYGENOXYGENKeen Compressed Gas Co. Inc.NDACurrent
48273-001OXYGENOXYGENKeen Compressed Gas Co. Inc.NDACurrent
48273-001OXYGENOXYGENKeen Compressed Gas Co. Inc.NDACurrent
48273-001OXYGENOXYGENKeen Compressed Gas Co. Inc.NDACurrent
48273-001OXYGENOXYGENKeen Compressed Gas Co. Inc.NDACurrent
48546-0001OXYGENOXYGENIndiana Oxygen Company, Inc.NDACurrent
48546-0001OXYGENOXYGENIndiana Oxygen Company, Inc.NDACurrent
48546-0001OXYGENOXYGENIndiana Oxygen Company, Inc.NDACurrent
48546-0001OXYGENOXYGENIndiana Oxygen Company, Inc.NDACurrent

Documents#

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