FDA.reportPublic FDA data

Application 216307

Type
NDA
Sponsor
GENERAL AIR SERVICE & SUPPLY COMPANY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HELIUM, 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMGeneral Air Service & Supply Coeb561a7a-9c50-3660-e053-2a95a90a97e92025-11-26Exact identifier
application applno (NDA): 216307
application number: NDA216307
ndc (product): 21220-200

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21220-200HeliumHeliumGeneral Air Service & Supply CoNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69517ORIG2021-12-08