FDA.reportPublic FDA data

Application 205985

Type
NDA
Sponsor
PRAXAIR CANADA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROGEN, NFNITROGENGAS;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
NitrogenNITROGENLinde Canada Inc.7fd42cc1-8e1e-43b3-981b-d0d6cf454f5a2025-12-30Exact identifier
application applno (NDA): 205985
application number: NDA205985
ndc (product): 49479-500

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
49479-500NitrogenNitrogenPraxair Canada, Inc.NDACurrent
49479-500NitrogenNitrogenPraxair Canada, Inc.NDACurrent
49479-500NitrogenNitrogenPraxair Canada, Inc.NDACurrent
49479-500NitrogenNitrogenLinde Canada Inc.NDACurrent
49479-500NitrogenNitrogenPraxair Canada, Inc.NDACurrent
49479-500NitrogenNitrogenLinde Canada Inc.NDACurrent
49479-500NitrogenNitrogenLinde Canada Inc.NDACurrent
49479-500NitrogenNitrogenPraxair Canada, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10536ORIG2015-09-29