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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020845

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NDA 020845 describes INOMAX, which is a drug marketed by Mallinckrodt Ireland and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INOMAX profile page.

The generic ingredient in INOMAX is nitric oxide. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.

Summary for 020845

Tradename:	INOMAX
Applicant:	Mallinckrodt Ireland
Ingredient:	nitric oxide
Patents:	17

Pharmacology for NDA: 020845

Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 020845

Bronchodilator Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Neurotransmitter Agents

Suppliers and Packaging for NDA: 020845

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INOMAX	nitric oxide	GAS;INHALATION	020845	NDA	INO Therapeutics LLC	64693-002	64693-002-01	1 CYLINDER in 1 CARTON (64693-002-01) / 353 L in 1 CYLINDER
INOMAX	nitric oxide	GAS;INHALATION	020845	NDA	INO Therapeutics LLC	64693-002	64693-002-02	1 CYLINDER in 1 CARTON (64693-002-02) / 1963 L in 1 CYLINDER

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GAS;INHALATION			Strength	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 1999	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Dec 30, 2029	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Get Started Free	Patent Expiration:	Jul 6, 2031	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Get Started Free	Patent Expiration:	Dec 30, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020845

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	⤷ Get Started Free	⤷ Get Started Free
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	⤷ Get Started Free	⤷ Get Started Free
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	⤷ Get Started Free	⤷ Get Started Free
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	⤷ Get Started Free	⤷ Get Started Free
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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