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
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
ndc (product): 81681-001
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
ndc (product): 76349-001
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
ndc (product): 71654-005

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 6 of 6 · 470 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64169-001OxygenOxygenIndustrial SourceNDACurrent
64169-001OxygenOxygenIndustrial SourceNDACurrent
64169-001OxygenOxygenIndustrial SourceNDACurrent
64169-001OxygenOxygenIndustrial SourceNDACurrent
64169-001OxygenOxygenEUGENE WELDERS SUPPLY CONDACurrent
64169-003AirAirIndustrial SourceNDACurrent
64169-003AirAirIndustrial SourceNDACurrent
64169-003AirAirIndustrial SourceNDACurrent
64169-003AirAirIndustrial SourceNDACurrent
64169-003AirAirEUGENE WELDERS SUPPLY CONDACurrent
64650-345OXYGENOXYGENAirweld, Inc dba Atlantic Welding SupplyNDACurrent
64650-345OXYGENOXYGENAirweld, Inc dba Atlantic Welding SupplyNDACurrent
64650-345OXYGENOXYGENAirweld, Inc dba Atlantic Welding SupplyNDACurrent
64650-345OXYGENOXYGENAirweld, Inc dba Atlantic Welding SupplyNDACurrent
64763-099OXYGENOXYGENJohnson Drug Company, IncNDACurrent
64763-099OXYGENOXYGENJohnson Drug Company, IncNDACurrent
64922-233OxygenOxygenADF Welding & Medical, Inc.NDACurrent
64922-233OxygenOxygenADF Welding & Medical, Inc.NDACurrent
64922-233OxygenOxygenADF Welding & Medical, Inc.NDACurrent
64922-233OxygenOxygenADF Welding & Medical, Inc.NDACurrent
64922-233OxygenOxygenADF Welding & Medical, Inc.NDACurrent
65119-345OXYGENOXYGENBronx Welding Supply IncNDACurrent
65119-345OXYGENOXYGENBronx Welding Supply IncNDACurrent
65119-345OXYGENOXYGENBronx Welding Supply IncNDACurrent
65119-345OXYGENOXYGENBronx Welding Supply IncNDACurrent
65119-345OXYGENOXYGENBronx Welding Supply IncNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
69240-001OxygenOxygenAcute Care Gases II, LLCNDACurrent
70273-001oxygenoxygenA & E Mill & Welding Supply CompanyNDACurrent
70273-001oxygenoxygenA & E Mill & Welding Supply CompanyNDACurrent
70273-001oxygenoxygenA & E Mill & Welding Supply CompanyNDACurrent
70273-001oxygenoxygenA & E Mill & Welding Supply CompanyNDACurrent
70273-001oxygenoxygenA & E Mill & Welding Supply CompanyNDACurrent
70513-001OxygenOxygenMedCare Equipment Company, LLCNDACurrent
70513-001OxygenOxygenMedCare Equipment Company, LLCNDACurrent
70513-001OxygenOxygenMedCare Equipment Company, LLCNDACurrent
70513-001OxygenOxygenMedCare Equipment Company, LLCNDACurrent
70513-001OxygenOxygenMedCare Equipment Company, LLCNDACurrent
71654-002OxygenOxygenSOUTHERN GAS AND SUPPLY, INC. dba Gas and SupplyNDACurrent
71654-005OxygenOxygenSOUTHERN GAS AND SUPPLY, INC. dba Gas and SupplyNDACurrent
71654-005OxygenOxygenSOUTHERN GAS AND SUPPLY, INC. dba Gas and SupplyNDACurrent
71654-005OxygenOxygenSOUTHERN GAS AND SUPPLY, INC. dba Gas and SupplyNDACurrent
71654-005OxygenOxygenSOUTHERN GAS AND SUPPLY, INC. dba Gas and SupplyNDACurrent
73468-005OxygenOxygenMagnegas Welding Supply-South, LLCNDACurrent
73468-005OxygenOxygenMagnegas Welding Supply-South, LLCNDACurrent
73468-005OxygenOxygenMagnegas Welding Supply-South, LLCNDACurrent
73468-005OxygenOxygenMagnegas Welding Supply-South, LLCNDACurrent
73468-005OxygenOxygenMagnegas Welding Supply-South, LLCNDACurrent
76349-001OxygenOxygenSouthern Gas and Supply LLCNDACurrent
76349-001OxygenOxygenSouthern Gas and Supply LLCNDACurrent
76349-001OxygenOxygenSouthern Gas and Supply LLCNDACurrent
76349-001OxygenOxygenSouthern Gas and Supply LLCNDACurrent
76349-001OxygenOxygenSouthern Gas and Supply LLCNDACurrent
81681-001OxygenOxygenWEST PENN LACO, INC.NDACurrent
81681-001OxygenOxygenWEST PENN LACO, INC.NDACurrent
81681-001OxygenOxygenWEST PENN LACO, INC.NDACurrent
81681-001OxygenOxygenWEST PENN LACO, INC.NDACurrent
81681-001OxygenOxygenWEST PENN LACO, INC.NDACurrent
81734-001OxygenOxygenCRYOGENIC SOLUTIONS LLCNDACurrent
81734-001OxygenOxygenCRYOGENIC SOLUTIONS LLCNDACurrent
81734-001OxygenOxygenCRYOGENIC SOLUTIONS LLCNDACurrent
82606-001OxygenOxygenAMERICAN GASES CORPORATIONNDACurrent

Documents#

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