FDA.reportPublic FDA data

Application 205843

Type
NDA
Sponsor
AIRGAS USA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HELIUM, USPHELIUMGAS;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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMMatheson Tri-Gas, Inc.12440277-7160-4e8e-99e2-39e4b4a2c8662025-12-02Exact identifier
ndc (product): 55037-501
HeliumHELIUMWSM SUPPLIER LLC.153317bb-7f55-0964-e063-6394a90a29222025-10-08Exact identifier
application applno (NDA): 205843
application number: NDA205843
HELIUMHELIUMAIRGAS USA, LLC61d7bc2a-a22d-4640-99ee-9737d39d07fe2025-09-03Exact identifier
application applno (NDA): 205843
application number: NDA205843
ndc (product): 11054-004
HELIUMHELIUMAir Source Industries Inc7d1d5963-8b7f-4d8d-807a-6b9f896c71712024-10-06Exact identifier
application applno (NDA): 205843
application number: NDA205843
ndc (product): 10167-300
Helium, OxygenHELIUM, OXYGENAIRGAS USA, LLC8485f6f4-f322-4b82-abff-47e64c713f1b2024-10-01Exact identifier
application applno (NDA): 205843
application number: NDA205843
ndc (product): 11054-042
Helium, OxygenHELIUM, OXYGENAIRGAS USA, LLC58ba729f-cca1-4e08-a131-dbe91258d99d2024-10-01Exact identifier
application applno (NDA): 205843
application number: NDA205843
ndc (product): 11054-041
Helium Oxygen mixtureHELIUM OXYGEN MIXTUREAirgas Usa, LLCdf74ce02-cbf4-49b3-8456-dc4fa7ddc9be2024-10-01Exact identifier
application applno (NDA): 205843
application number: NDA205843
ndc (product): 11054-032

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10167-300HELIUMHELIUMAir Source Industries IncNDACurrent
10167-300HELIUMHELIUMAir Source Industries IncNDACurrent
10167-300HELIUMHELIUMAir Source Industries IncNDACurrent
10167-300HELIUMHELIUMAir Source Industries IncNDACurrent
10167-300HELIUMHELIUMAir Source Industries IncNDACurrent
10167-300HELIUMHELIUMAir Source Industries IncNDACurrent
10167-300HELIUMHELIUMAir Source Industries IncNDACurrent
11054-004HELIUMHELIUMAIRGAS USA, LLCNDACurrent
11054-004HELIUMHELIUMAIRGAS USA, LLCNDACurrent
11054-004HELIUMHELIUMAIRGAS USA, LLCNDACurrent
11054-004HELIUMHELIUMAIRGAS USA, LLCNDACurrent
11054-004HELIUMHELIUMAIRGAS USA, LLCNDACurrent
11054-032Helium Oxygen mixtureHelium Oxygen mixtureAirgas Usa, LLCNDA AUTHORIZED GENERICCurrent
11054-032Helium Oxygen mixtureHelium Oxygen mixtureAirgas Usa, LLCNDA AUTHORIZED GENERICCurrent
11054-032Helium Oxygen mixtureHelium Oxygen mixtureAirgas Usa, LLCNDA AUTHORIZED GENERICCurrent
11054-032Helium Oxygen mixtureHelium Oxygen mixtureAirgas Usa, LLCNDA AUTHORIZED GENERICCurrent
11054-032Helium Oxygen mixtureHelium Oxygen mixtureAirgas Usa, LLCNDA AUTHORIZED GENERICCurrent
11054-041Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
11054-041Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
11054-041Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
11054-041Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
11054-041Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
11054-042Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
11054-042Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
11054-042Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
11054-042Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
11054-042Helium, OxygenHelium, OxygenAIRGAS USA, LLCNDA AUTHORIZED GENERICCurrent
55037-501HeliumHeliumMatheson Tri-Gas, Inc.NDACurrent
55037-501HeliumHeliumMatheson Tri-Gas, Inc.NDACurrent
55037-501HeliumHeliumMatheson Tri-Gas, Inc.NDACurrent
55037-501HeliumHeliumMatheson Tri-Gas, Inc.NDACurrent
55037-501HeliumHeliumMatheson Tri-Gas, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10517ORIG2015-10-02