FDA.reportPublic FDA data

Application 205912

Type
NDA
Sponsor
PRAXAIR DISTRIBUTION 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMLinde Gas & Equipment Inc.bf6e56a4-0193-4436-ae0d-cb0f0f65c2fc2025-01-15Exact identifier
application applno (NDA): 205912
application number: NDA205912
ndc (product): 59579-005

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21220-121HeliumHeliumGeneral Air Service & Supply CoNDACurrent
21220-121HeliumHeliumGeneral Air Service & Supply CoNDACurrent
21220-121HeliumHeliumGeneral Air Service & Supply CoNDACurrent
21220-121HeliumHeliumGeneral Air Service & Supply CoNDACurrent
21220-121HeliumHeliumGeneral Air Service & Supply CoNDACurrent
59579-005HeliumHeliumPraxair Distribution, Inc.NDACurrent
59579-005HeliumHeliumPraxair Distribution, Inc.NDACurrent
59579-005HeliumHeliumPraxair Distribution, Inc.NDACurrent
59579-005HeliumHeliumPraxair Distribution, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32765ORIG2015-09-29