FDA.reportPublic FDA data

Application 205862

Type
NDA
Sponsor
ASPEN AIR

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
OXYGENOXYGENAspen Air U.S., LLC66767af9-a49d-4441-b7ad-a2632aa5604c2024-10-10Exact identifier
application applno (NDA): 205862
application number: NDA205862
ndc (product): 42914-001

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
42914-001OXYGENOXYGENAspen Air U.S., LLCNDACurrent
42914-001OXYGENOXYGENAspen Air US CorpNDACurrent
42914-001OXYGENOXYGENAspen Air U.S., LLCNDACurrent
42914-001OXYGENOXYGENAspen Air U.S., LLCNDACurrent
42914-001OXYGENOXYGENAspen Air U.S., LLCNDACurrent
42914-001OXYGENOXYGENAspen Air U.S., LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32757ORIG2015-09-29