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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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