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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077094

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NDA 077094 describes RIBAVIRIN, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, Teva, Zydus Pharms Usa, Navinta Llc, Beximco Pharms Usa, Heritage Pharma Avet, and Sandoz, and is included in eleven NDAs. It is available from three suppliers. Additional details are available on the RIBAVIRIN profile page.

The generic ingredient in RIBAVIRIN is ribavirin. There are fifteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ribavirin profile page.

Summary for 077094

Tradename:	RIBAVIRIN
Applicant:	Zydus Pharms Usa
Ingredient:	ribavirin
Patents:	0

Medical Subject Heading (MeSH) Categories for 077094

Antimetabolites
Antiviral Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 5, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Mar 16, 2007	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Mar 16, 2007	TE:		RLD:	No

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