FDA.reportPublic FDA data

Application 205847

Type
NDA
Sponsor
OXARC INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEDICAL AIR, USPMEDICAL AIRGAS;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
AirAIROxarc, LLC5fe22b62-e836-497e-bd7e-55bba80304992025-11-25Exact identifier
application applno (NDA): 205847
application number: NDA205847
ndc (product): 34057-006

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
34057-006AirAirOxarc, Inc.NDACurrent
34057-006AirAirOxarc, Inc.NDACurrent
34057-006AirAirOxarc, Inc.NDACurrent
34057-006AirAirOxarc, Inc.NDACurrent
34057-006AirAirOxarc, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32753ORIG2015-10-02