FDA.reportPublic FDA data

Application 206826

Type
NDA
Sponsor
LINDE GAS NORTH AMERICA LLC

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMHaun Specialty Gases, Inc.5e036b6f-95cf-4c9b-883a-12675015d4752025-12-29Exact identifier
application applno (NDA): 206826
application number: NDA206826
ndc (product): 14961-005
HeliumHELIUMKeen Compressed Gas Co. Inc.8bb1e27a-6855-a7c1-e053-2995a90a261e2025-11-17Exact identifier
application applno (NDA): 206826
application number: NDA206826
ndc (product): 48273-011
HeliumHELIUMAero All Gas Company2e9012ae-8ff1-4858-a1e9-e2c3959b2f572025-10-28Exact identifier
application applno (NDA): 206826
application number: NDA206826
ndc (product): 10014-004

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10014-004HeliumHeliumAero All Gas CompanyNDACurrent
10014-004HeliumHeliumAero All Gas CompanyNDACurrent
10014-004HeliumHeliumAero All Gas CompanyNDACurrent
10014-004HeliumHeliumAero All Gas CompanyNDACurrent
10014-004HeliumHeliumAero All Gas CompanyNDACurrent
14961-005HeliumHeliumHaun Specialty Gases, Inc.NDACurrent
14961-005HeliumHeliumHaun Specialty Gases, Inc.NDACurrent
14961-005HeliumHeliumHaun Specialty Gases, Inc.NDACurrent
14961-005HeliumHeliumHaun Specialty Gases, Inc.NDACurrent
14961-005HeliumHeliumHaun Specialty Gases, Inc.NDACurrent
25373-010HeliumHeliumLinde Gas North America LLCNDACurrent
25373-010HeliumHeliumLinde Gas & Equipment Inc.NDACurrent
48273-011HeliumHeliumKeen Compressed Gas Co. Inc.NDACurrent
48273-011HeliumHeliumKeen Compressed Gas Co. Inc.NDACurrent
48273-011HeliumHeliumKeen Compressed Gas Co. Inc.NDACurrent
48273-011HeliumHeliumKeen Compressed Gas Co. Inc.NDACurrent
48273-011HeliumHeliumKeen Compressed Gas Co. Inc.NDACurrent
48273-011HeliumHeliumKeen Compressed Gas Co. Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10595ORIG2015-10-02