FDA.reportPublic FDA data

Application 205851

Type
NDA
Sponsor
PRAXAIR INC

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMNexAir, LLCcb33fc07-e122-4f66-aa43-b659ee1501502026-05-22Exact identifier
ndc (product): 12213-710
HeliumHELIUMAGL Inhalation Therapy Co.b309a459-c8bc-4ac3-a4e2-3989a63be8a92026-03-02Exact identifier
ndc (product): 17575-005
Helium Oxygen Nitrogen mixtureHELIUM OXYGEN NITROGEN MIXTURELinde Gas & Equipment Inc.619c58a9-7eae-450a-aa89-0027a388ce062025-12-30Exact identifier
ndc (product): 59579-010
Helium Oxygen mixtureHELIUM OXYGEN MIXTURELinde Gas & Equipment Inc.ef29f856-4675-4bb7-adef-67d7c6f274392025-01-24Exact identifier
ndc (product): 59579-009

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12213-710HeliumHeliumNexAir, LLCNDACurrent
12213-710HeliumHeliumNexAir, LLCNDACurrent
12213-710HeliumHeliumNexAir, LLCNDACurrent
12213-710HeliumHeliumNexAir, LLCNDACurrent
12213-710HeliumHeliumNexAir, LLCNDACurrent
12213-710HeliumHeliumNexAir, LLCNDACurrent
17575-005HeliumHeliumAGL Inhalation Therapy Co.NDACurrent
49575-020HeliumHeliumMachine & Welding Supply Company dba Arc3 Gases SouthNDACurrent
49575-020HeliumHeliumMachine & Welding Supply Company dba Arc3 Gases SouthNDACurrent
59579-009Helium Oxygen mixtureHelium Oxygen mixturePraxair Distribution, Inc.NDA AUTHORIZED GENERICCurrent
59579-009Helium Oxygen mixtureHelium Oxygen mixturePraxair Distribution, Inc.NDA AUTHORIZED GENERICCurrent
59579-009Helium Oxygen mixtureHelium Oxygen mixturePraxair Distribution, Inc.NDA AUTHORIZED GENERICCurrent
59579-009Helium Oxygen mixtureHelium Oxygen mixturePraxair Distribution, Inc.NDA AUTHORIZED GENERICCurrent
59579-010Helium Oxygen Nitrogen mixtureHelium Oxygen Nitrogen mixturePraxair Distribution, Inc.NDA AUTHORIZED GENERICCurrent
59579-010Helium Oxygen Nitrogen mixtureHelium Oxygen Nitrogen mixturePraxair Distribution, Inc.NDA AUTHORIZED GENERICCurrent
59579-010Helium Oxygen Nitrogen mixtureHelium Oxygen Nitrogen mixturePraxair Distribution, Inc.NDA AUTHORIZED GENERICCurrent
59579-010Helium Oxygen Nitrogen mixtureHelium Oxygen Nitrogen mixturePraxair Distribution, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32755ORIG2015-09-30