FDA.reportPublic FDA data

Application 209033

Type
NDA
Sponsor
NEXAIR LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
000HELIUM, USPHELIUMGAS;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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMNexAir, LLCcb33fc07-e122-4f66-aa43-b659ee1501502026-05-22Exact identifier
application applno (NDA): 209033
application number: NDA209033

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60176ORIG2019-10-01