FDA.reportPublic FDA data

Application 206014

Type
NDA
Sponsor
NITROUS OXIDE OF CANADA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROUS OXIDE, USPNITROUS OXIDEGAS;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
Nitrous OxideNITROUS OXIDEHelget Gas Productsc8ea7d9d-d0c3-4ce4-a6e0-3ca0286d97952025-11-12Exact identifier
application applno (NDA): 206014
application number: NDA206014

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52086-003Nitrous OxideNitrous OxideHelget Gas ProductsNDACurrent
52086-003Nitrous OxideNitrous OxideHelget Gas ProductsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10538ORIG2015-09-30