Application 205829

Type: NDA
Sponsor: AIR LIQUIDE AMERICA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROGEN, NF	NITROGEN	GAS;INHALATION	N/A	No	No

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrogen	NITROGEN	SYOXSA, Inc.	66b47ed5-82d0-44ba-a2aa-17db9b98ee22	2025-12-12		Exact identifier application applno (NDA): 205829 application number: NDA205829 ndc (product): 23647-002

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10671-020	NITROGEN	NITROGEN	Air Liquide America L.P.	NDA	Current
10671-021	NITROGEN	NITROGEN	Air Liquide America L.P.	NDA	Current
10671-022	NITROGEN	NITROGEN	Air Liquide America L.P.	NDA	Current
10671-023	NITROGEN	NITROGEN	Air Liquide America L.P.	NDA	Current
23647-002	Nitrogen	Nitrogen	SYOXSA, Inc.	NDA	Current
23647-002	Nitrogen	Nitrogen	SYOXSA, Inc.	NDA	Current
23647-002	Nitrogen	Nitrogen	SYOXSA, Inc.	NDA	Current
23647-002	Nitrogen	Nitrogen	SYOXSA, Inc.	NDA	Current
23647-002	Nitrogen	Nitrogen	SYOXSA, Inc.	NDA	Current

Application 205829

Related Records#

Application Products#

openFDA label cross-check#

NDC Listings For This Application#