Application 211737

Type: NDA
Sponsor: CRISTAL ASU LLC

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	Ineos Pigments ASU LLC	e2b7e83b-e1ba-446b-aff9-ff7050839eff	2024-10-27		Exact identifier application applno (NDA): 211737 application number: NDA211737 ndc (product): 71408-003

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71408-002	Nitrogen	Nitrogen	Ineos Pigments Asu LLC	NDA	Current
71408-003	Nitrogen	Nitrogen	Ineos Pigments Asu LLC	NDA	Current
71408-003	Nitrogen	Nitrogen	Ineos Pigments Asu LLC	NDA	Current
71408-003	Nitrogen	Nitrogen	Ineos Pigments Asu LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58055	ORIG	2019-03-21