FDA.reportPublic FDA data

Application 205986

Type
NDA
Sponsor
PRAXAIR CANADA 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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENLinde Canada Inc.ae2013c3-a153-4eb3-9168-01d0b5df7ad02025-12-30Exact identifier
application applno (NDA): 205986
application number: NDA205986
ndc (product): 49479-722

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49479-722OxygenOxygenPraxair Canada, Inc.NDACurrent
49479-722OxygenOxygenPraxair Canada, Inc.NDACurrent
49479-722OxygenOxygenLinde Canada Inc.NDACurrent
49479-722OxygenOxygenLinde Canada Inc.NDACurrent
49479-722OxygenOxygenPraxair Canada, Inc.NDACurrent
49479-722OxygenOxygenPraxair Canada, Inc.NDACurrent
49479-722OxygenOxygenPraxair Canada, Inc.NDACurrent
49479-722OxygenOxygenLinde Canada Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10537ORIG2015-09-30