FDA.reportPublic FDA data

Application 205819

Type
NDA
Sponsor
NORCO 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
HeliumHELIUMAGL Inhalation Therapy Co.b309a459-c8bc-4ac3-a4e2-3989a63be8a92026-03-02Exact identifier
application applno (NDA): 205819
application number: NDA205819
ndc (product): 17575-005
HELIUMHELIUMNorco, Inc.e1d2805c-1ede-4de5-b06e-f5cffc3ffd3c2025-08-31Exact identifier
application applno (NDA): 205819
application number: NDA205819
ndc (product): 42602-002

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17575-005HeliumHeliumAGL Inhalation Therapy Co.NDACurrent
17575-005HeliumHeliumAGL Inhalation Therapy Co.NDACurrent
17575-005HeliumHeliumAGL Inhalation Therapy Co.NDACurrent
17575-005HeliumHeliumAGL Inhalation Therapy Co.NDACurrent
42602-002HELIUMHELIUMNorco, Inc.NDACurrent
42602-002HELIUMHELIUMNorco, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32735ORIG2015-10-06