Details for New Drug Application (NDA): 202860

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NDA 202860 describes GENOSYL, which is a drug marketed by Vero Biotech Inc and is included in one NDA. It is available from one supplier. There are twenty-four patents protecting this drug. Additional details are available on the GENOSYL profile page.

The generic ingredient in GENOSYL 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 202860

Tradename:	GENOSYL
Applicant:	Vero Biotech Inc
Ingredient:	nitric oxide
Patents:	24

Pharmacology for NDA: 202860

Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 202860

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

Suppliers and Packaging for NDA: 202860

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GENOSYL	nitric oxide	GAS;INHALATION	202860	NDA	VERO BIOTECH, INC.	72385-001	72385-001-01	216 L in 1 CARTRIDGE (72385-001-01)
GENOSYL	nitric oxide	GAS;INHALATION	202860	NDA	VERO BIOTECH, INC.	72385-002	72385-002-01	216 L in 1 CARTRIDGE (72385-002-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GAS;INHALATION			Strength	800PPM
Approval Date:	Dec 20, 2019	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 18, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
Patent:	⤷ Sign Up	Patent Expiration:	Feb 12, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Oct 20, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202860

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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