Application 205992

Type: NDA
Sponsor: UNITED STATES WELDING INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEDICAL AIR, USP	MEDICAL AIR	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
AIR COMPRESSED	AIR COMPRESSED (MEDICAL AIR USP)	United States Welding, Inc.	ee69dfbc-8860-45a9-9be4-bf1257afe001	2026-06-01		Exact identifier application applno (NDA): 205992 application number: NDA205992 ndc (product): 54218-400

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
54218-400	AIR COMPRESSED	AIR COMPRESSED (MEDICAL AIR USP)	United States Welding, Inc.	NDA	Current
54218-400	AIR COMPRESSED	AIR COMPRESSED (MEDICAL AIR USP)	United States Welding, Inc.	NDA	Current
54218-400	AIR COMPRESSED	AIR COMPRESSED (MEDICAL AIR USP)	United States Welding, Inc.	NDA	Current
54218-400	AIR COMPRESSED	AIR COMPRESSED (MEDICAL AIR USP)	United States Welding, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32772	ORIG	2015-09-30