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Last Updated: April 19, 2024

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. Eight 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

Antimetabolites
Antiviral Agents

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:	RX	Dosage:	FOR SOLUTION;INHALATION			Strength	6GM/VIAL
Approval Date:	Dec 31, 1985	TE:	AN	RLD:	Yes

Expired US Patents for NDA 018859

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985	⤷ Try a Trial	⤷ Try a Trial
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985	⤷ Try a Trial	⤷ Try a Trial
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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