FDA.reportPublic FDA data

Application 213990

Type
NDA
Sponsor
ILMO Products Company

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001Helium, USPGAS;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
HeliumHELIUMILMO Products Company9aefb755-268a-1d8b-e053-2a95a90a1df72025-10-29Exact identifier
application applno (NDA): 213990
application number: NDA213990
ndc (product): 51486-020

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
51486-020HeliumHeliumILMO Products CompanyNDACurrent
51486-020HeliumHeliumILMO Products CompanyNDACurrent
51486-020HeliumHeliumILMO Products CompanyNDACurrent
51486-020HeliumHeliumILMO Products CompanyNDACurrent
51486-020HeliumHeliumILMO Products CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62583ORIG2020-04-16