FDA.reportPublic FDA data

Application 215007

Type
NDA
Sponsor
NEXAIR LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBON DIOXIDE, USPCARBON DIOIDEGAS;INHALATIONN/ANoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbon DioxideCARBON DIOXIDENexAir, LLCb0a1e508-3610-3b44-e053-2995a90ac6e22026-05-21Exact identifier
application applno (NDA): 215007
application number: NDA215007
ndc (product): 12213-900

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
12213-900Carbon DioxideCarbon DioxideNexAir, LLCNDACurrent
12213-900Carbon DioxideCarbon DioxideNexAir, LLCNDACurrent
12213-900Carbon DioxideCarbon DioxideNexAir, LLCNDACurrent
12213-900Carbon DioxideCarbon DioxideNexAir, LLCNDACurrent
12213-900Carbon DioxideCarbon DioxideNexAir, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64160ORIG2020-07-31