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
ndc (product): 51887-502
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
ndc (product): 52438-011
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
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
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
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
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
ndc (product): 53991-001
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 4 of 6 · 470 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51400-001OXYGENOXYGENMid South Welding Supply, IncNDACurrent
51400-001OXYGENOXYGENMID-SOUTH WELDING SUPPLY, INC.NDACurrent
51887-502AirAirMaine Oxy-Acetylene Supply CompanyNDACurrent
51887-502AirAirMaine Oxy-Acetylene Supply CompanyNDACurrent
51887-502AirAirMaine Oxy-Acetylene Supply CompanyNDACurrent
51887-502AirAirMaine Oxy-Acetylene Supply CompanyNDACurrent
51887-502AirAirMaine Oxy-Acetylene Supply CompanyNDACurrent
51887-720OxygenOxygenMaine Oxy-Acetylene Supply CompanyNDACurrent
51887-720OxygenOxygenMaine Oxy-Acetylene Supply CompanyNDACurrent
51887-720OxygenOxygenMaine Oxy-Acetylene Supply CompanyNDACurrent
51887-720OxygenOxygenMaine Oxy-Acetylene Supply CompanyNDACurrent
51887-720OxygenOxygenMaine Oxy-Acetylene Supply CompanyNDACurrent
51960-001OXYGENOXYGENKent Welding SupplyNDACurrent
51960-001OXYGENOXYGENKent Welding SupplyNDACurrent
51960-001OXYGENOXYGENKent Welding SupplyNDACurrent
51960-001OXYGENOXYGENKent Welding SupplyNDACurrent
51960-001OXYGENOXYGENKent Welding SupplyNDACurrent
52279-001OxygenOxygenWesco Gas & Welding Supply, Inc.NDACurrent
52279-001OxygenOxygenWesco Gas & Welding Supply, Inc.NDACurrent
52279-001OxygenOxygenWesco Gas & Welding Supply, Inc.NDACurrent
52279-001OxygenOxygenWesco Gas & Welding Supply, Inc.NDACurrent
52279-001OxygenOxygenWesco Gas & Welding Supply, Inc.NDACurrent
52438-011OxygenOxygenMesser LLCNDACurrent
52438-011OxygenOxygenMesser LLCNDACurrent
52438-011OxygenOxygenMesser LLCNDACurrent
52438-011OxygenOxygenMesser LLCNDACurrent
52438-011OxygenOxygenLinde LLCNDACurrent
52438-011OxygenOxygenMesser LLCNDACurrent
52557-001OxygenOxygenCornerstone Mecial Services - Midwest, LLCNDACurrent
52751-001OXYGENOXYGENRezk Medical SupplyNDACurrent
52751-001OXYGENOXYGENRezk Medical SupplyNDACurrent
53440-001OxygenOxygenWestair Gases & Equipment, Inc.NDACurrent
53440-001OxygenOxygenWestair Gases & Equipment, Inc.NDACurrent
53440-001OxygenOxygenWestair Gases & Equipment, Inc.NDACurrent
53440-001OxygenOxygenWestair Gases & Equipment, Inc.NDACurrent
53440-001OxygenOxygenWestair Gases & Equipment, Inc.NDACurrent
53440-007AirAirWestair Gases & Equipment, Inc.NDACurrent
53440-007AirAirWestair Gases & Equipment, Inc.NDACurrent
53440-007AirAirWestair Gases & Equipment, Inc.NDACurrent
53440-007AirAirWestair Gases & Equipment, Inc.NDACurrent
53440-007AirAirWestair Gases & Equipment, Inc.NDACurrent
53440-008CarbogenCarbogenWestair Gases & Equipment, Inc.NDACurrent
53440-008CarbogenCarbogenWestair Gases & Equipment, Inc.NDACurrent
53440-008CarbogenCarbogenWestair Gases & Equipment, Inc.NDACurrent
53440-008CarbogenCarbogenWestair Gases & Equipment, Inc.NDACurrent
53440-008CarbogenCarbogenWestair Gases & Equipment, Inc.NDACurrent
53452-001OxygenOxygenDale Oxygen And Acetylene Service, IncNDACurrent
53452-001OxygenOxygenDale Oxygen And Acetylene Service, IncNDACurrent
53452-001OxygenOxygenDale Oxygen And Acetylene Service, IncNDACurrent
53452-001OxygenOxygenDale Oxygen And Acetylene Service, IncNDACurrent
53452-001OxygenOxygenDale Oxygen And Acetylene Service, IncNDACurrent
53452-003AirAirDale Oxygen And Acetylene Service, IncNDACurrent
53452-003AirAirDale Oxygen And Acetylene Service, IncNDACurrent
53452-003AirAirDale Oxygen And Acetylene Service, IncNDACurrent
53452-003AirAirDale Oxygen And Acetylene Service, IncNDACurrent
53452-003AirAirDale Oxygen And Acetylene Service, IncNDACurrent
53991-001OxygenOxygenSouthern Gas and Supply of Mississippi, Inc.NDACurrent
53991-001OxygenOxygenSouthern Gas and Supply of Mississippi, Inc.NDACurrent
53991-001OxygenOxygenSouthern Gas and Supply of Mississippi, Inc.NDACurrent
53991-001OxygenOxygenSouthern Gas and Supply of Mississippi, Inc.NDACurrent
53991-001OxygenOxygenSouthern Gas and Supply of Mississippi, Inc.NDACurrent
54218-500OXYGENOXYGENUnited States Welding, Inc.NDACurrent
54218-500OXYGENOXYGENUnited States Welding, Inc.NDACurrent
54218-500OXYGENOXYGENUnited States Welding, Inc.NDACurrent
54218-500OXYGENOXYGENUnited States Welding, Inc.NDACurrent
54218-500OXYGENOXYGENUnited States Welding, Inc.NDACurrent
54218-500OXYGENOXYGENUnited States Welding, Inc.NDACurrent
54218-500OXYGENOXYGENUnited States Welding, Inc.NDACurrent
54316-123OXYGENOXYGENYoungstown Oxygen & Welding Supply, Inc.NDACurrent
54316-123OXYGENOXYGENYoungstown Oxygen & Welding Supply, Inc.NDACurrent
54316-123OXYGENOXYGENYoungstown Oxygen & Welding Supply, Inc.NDACurrent
54316-123OXYGENOXYGENYoungstown Oxygen & Welding Supply, Inc.NDACurrent
54316-123OXYGENOXYGENYoungstown Oxygen & Welding Supply, Inc.NDACurrent
54451-001OxygenOxygenBaker's Gas & Welding Supplies Inc.NDACurrent
54451-001OxygenOxygenBaker's Gas & Welding Supplies Inc.NDACurrent
54451-001OxygenOxygenBaker's Gas & Welding Supplies Inc.NDACurrent
54451-001OxygenOxygenBaker's Gas & Welding Supplies Inc.NDACurrent
54451-001OxygenOxygenBaker's Gas & Welding Supplies Inc.NDACurrent
54767-001oxygenoxygenShaw Oxygen Company IncNDACurrent
54767-001oxygenoxygenShaw Oxygen Company IncNDACurrent

Documents#

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