FDA.reportPublic FDA data

Application 211781

Type
NDA
Sponsor
A-OX WELDING SUPPLY CO, 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMA-OX Welding Supply, LLC7046ef16-a4f4-15b7-e053-2a91aa0a4f1a2025-10-23Exact identifier
application applno (NDA): 211781
application number: NDA211781
ndc (product): 10297-006
HeliumHELIUMMachine & Welding Supply Company dba Arc3 Gases South44ff03e6-f79d-eb6c-e063-6294a90aba5b2024-12-06Exact identifier
application applno (NDA): 211781
application number: NDA211781

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
10297-006HeliumHeliumA-OX WELDING SUPPLY CO., INC.NDACurrent
10297-006HeliumHeliumA-OX WELDING SUPPLY CO., INC.NDACurrent
10297-006HeliumHeliumA-OX WELDING SUPPLY CO., INC.NDACurrent
10297-006HeliumHeliumA-OX WELDING SUPPLY CO., INC.NDACurrent
10297-006HeliumHeliumA-OX WELDING SUPPLY CO., INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55333ORIG2018-08-27