Nitric Oxide

Sold as Inomax, Genosyl. Every FDA application for this active ingredient: 2 branded and 2 generic.

As of Nov 13, 2026, FDA lists 4 applications for Nitric Oxide (sold as Inomax, Genosyl), first approved Dec 23, 1999, with 2 new uses approved and 2 published complete response letters.

First approved: Dec 23, 1999
Applications: 4
New uses approved: 2
Complete response letters: 2
First approved in Japan: Jul 16, 2008

Approvals in Japan (PMDA)

First approved in Japan 103 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

INOfloA drug with a new additional indication and a new dosage for the improvement of pulmonary hypertension in the perioperative period of cardiac surgery. · INO Therapeutics LLC · Aug 24, 2015
INOflo, new ingredientA drug containing a new active ingredient indicated for the treatment of hypoxic respiratory failure (HRF) with concurrent pulmonary hypertension in neonates. · INO therapeutics LLC · Jul 16, 2008

Clinical Trials

146 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Metabolic Changes in Heart Failure Patients Treated With VericiguatHeart Failure, Worsening Heart Failure · University of Salerno	—	Not yet recruiting	Oct 28, 2026
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory FailureAcute Respiratory Failure (ARF), Nitric Oxide · Southeast University, China	Not applicable	Not yet recruiting	Oct 23, 2026
Circuit Breathing Exercise on Smoking Cessation Among Youth E-Cigarette UsersE Cigarette Use · Chulalongkorn University	Not applicable	Recruiting	Oct 21, 2026
Effect of Melatonin on Pulmonary Hypertension in Full Term NeonatesCongenital Peumonia, Persistent Pulmonary Hypertension of Newborn · Ain Shams University	Not applicable	Recruiting	Sep 30, 2026
Post Market Clinical Follow-up to Assess the Portable Nitric Oxide Generation and Delivery System (INOwill N200) for the Treatment of Neonatal Hypoxic Respiratory Failure Complicated by Pulmonary HypertensionPersistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure · Novlead Inc.	—	Not yet recruiting	Sep 24, 2026
Comparing Advanced Technologies to Standard Testing for the Diagnosis of Airway Disease in Hospital and Community SettingsCOPD (Chronic Obstructive Pulmonary Disease), Airway Disease · University Hospital Southampton NHS Foundation Trust	—	Recruiting	Sep 1, 2026
Savannah Environmental Nutrition Study (SENS): Nutrition Intervention to Reduce Air Pollution-Related Airway Inflammation and Oxidative StressAir Pollution Exposure, Oxidative Stress · Georgia Southern University	Not applicable	Not yet recruiting	Sep 1, 2026
First-Line Diagnostic Investigations for Suspected Adult AsthmaAsthma (Diagnosis) · George Eliot Hospital	—	Active, not recruiting	Aug 28, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 23, 1999	InomaxNDA 20845 · New molecular entity	Mallinckrodt Ireland	12	Marketed
Oct 2, 2018	NoxiventANDA 207141	Vero Biotech Inc	1	Marketed
Dec 20, 2019	GenosylNDA 202860 · New formulation or manufacturer	Vero Biotech Inc	0	Marketed
Jul 27, 2023	UlspiraANDA 203144	Airgas Therap	0	Marketed

Complete Response Letters

FDA's published letters for these applications


Jan 23, 2019	GENOsyl Delivery System (Nitric Oxide)Facility Inspections, Cdrh (Device, Human Factors	Approved
Jun 28, 2013	NDA 202860Product Quality, Labeling, Facility Inspections	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA