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Last Updated: July 12, 2020

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Details for New Drug Application (NDA): 018859


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NDA 018859 describes VIRAZOLE, which is a drug marketed by Valeant Pharm Intl and is included in one NDA. It is available from three 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. Nine suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
Summary for 018859
Tradename:VIRAZOLE
Applicant:Valeant Pharm Intl
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
Paragraph IV (Patent) Challenges for 018859
Tradename Dosage Ingredient NDA Submissiondate
VIRAZOLE FOR SOLUTION;INHALATION ribavirin 018859 2014-05-22

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
Valeant Pharm Intl VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985   Start Trial   Start Trial
Valeant Pharm Intl VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985   Start Trial   Start Trial
Valeant Pharm Intl VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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