FDA.reportPublic FDA data

Application 212539

Type
NDA
Sponsor
MATHESON TRI-GAS INC

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMMatheson Tri-Gas, Inc.12440277-7160-4e8e-99e2-39e4b4a2c8662025-12-02Exact identifier
application applno (NDA): 212539
application number: NDA212539

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77355ORIG 2024-01-30