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Last Updated: March 29, 2024

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 202860
Physiological EffectVasodilation
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:RXDosage:GAS;INHALATIONStrength800PPM
Approval Date:Dec 20, 2019TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Aug 18, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
Patent:⤷  Try a TrialPatent Expiration:Feb 12, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Oct 20, 2035Product Flag?YSubstance Flag?Delist Request?

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