Application 211739

Type: NDA
Sponsor: CRISTAL ASU LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYGEN, USP	OXYGEN	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
Oxygen	OXYGEN	Ineos Pigments ASU LLC	d130e778-a02c-4762-b09a-85358e0994ce	2024-10-27		Exact identifier application applno (NDA): 211739 application number: NDA211739 ndc (product): 71408-001

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71408-001	Oxygen	Oxygen	Ineos Pigments Asu LLC	NDA	Current
71408-001	Oxygen	Oxygen	Ineos Pigments Asu LLC	NDA	Current
71408-001	Oxygen	Oxygen	Ineos Pigments Asu LLC	NDA	Current
71408-001	Oxygen	Oxygen	Ineos Pigments Asu LLC	NDA	Current
71408-001	Oxygen	Oxygen	Ineos Pigments Asu LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58056	ORIG	2019-03-21