Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203144
Company: AIRGAS THERAP

Products on ANDA 203144

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ULSPIRA	NITRIC OXIDE	800PPM	GAS;INHALATION	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203144

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2023	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203144

ULSPIRA

GAS;INHALATION; 800PPM
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INOMAX	NITRIC OXIDE	800PPM	GAS;INHALATION	Prescription	Yes	AA	020845	MALLINCKRODT HOSP
NOXIVENT	NITRIC OXIDE	800PPM	GAS;INHALATION	Prescription	No	AA	207141	LINDE GAS EQUIP
ULSPIRA	NITRIC OXIDE	800PPM	GAS;INHALATION	Prescription	No	AA	203144	AIRGAS THERAP