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Last Updated: August 11, 2022

Details for New Drug Application (NDA): 018859


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NDA 018859 describes VIRAZOLE, which is a drug marketed by Bausch and is included in one NDA. It is available from four suppliers. Additional details are available on the VIRAZOLE profile page.

The generic ingredient in VIRAZOLE is ribavirin. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
Summary for 018859
Tradename:VIRAZOLE
Applicant:Bausch
Ingredient:ribavirin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018859
Medical Subject Heading (MeSH) Categories for 018859
Suppliers and Packaging for NDA: 018859
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859 NDA Bausch Health US, LLC 0187-0007 0187-0007-01 1 VIAL, GLASS in 1 CARTON (0187-0007-01) > 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS
VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859 NDA Bausch Health US, LLC 0187-0007 0187-0007-14 4 VIAL, GLASS in 1 CARTON (0187-0007-14) > 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;INHALATIONStrength6GM/VIAL
Approval Date:Dec 31, 1985TE:ANRLD:Yes

Expired US Patents for NDA 018859

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985 See Plans and Pricing See Plans and Pricing
Bausch VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985 See Plans and Pricing See Plans and Pricing
Bausch VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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