FDA.reportPublic FDA data

Application 205817

Type
NDA
Sponsor
LINDE NORTH AMERICA 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
OxygenOXYGENMesser Canada Inc.eec2b17b-4ee5-614d-d055-2ed4aaff33572025-11-14Exact identifier
application applno (NDA): 205817
application number: NDA205817
ndc (product): 52003-011

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52003-011OxygenOxygenMesser Canada Inc.NDACurrent
52003-011OxygenOxygenMesser Canada Inc.NDACurrent
52003-011OxygenOxygenMesser Canada Inc.NDACurrent
52003-011OxygenOxygenMesser Canada LTDNDACurrent
52003-011OxygenOxygenMesser Canada Inc.NDACurrent
52003-011OxygenOxygenLinde Canada LTDNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32733ORIG2015-10-01