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Last Updated: March 19, 2025

Details for New Drug Application (NDA): 079111

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NDA 079111 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 four 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. Eight suppliers are listed for this compound. Additional details are available on the ribavirin profile page.

Summary for 079111

Tradename:	RIBAVIRIN
Applicant:	Aurobindo Pharma
Ingredient:	ribavirin
Patents:	0

Pharmacology for NDA: 079111

Medical Subject Heading (MeSH) Categories for 079111

Antimetabolites
Antiviral Agents

Suppliers and Packaging for NDA: 079111

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIBAVIRIN	ribavirin	TABLET;ORAL	079111	ANDA	Aurobindo Pharma Limited	65862-207	65862-207-05	500 TABLET, FILM COATED in 1 BOTTLE (65862-207-05)
RIBAVIRIN	ribavirin	TABLET;ORAL	079111	ANDA	Aurobindo Pharma Limited	65862-207	65862-207-68	168 TABLET, FILM COATED in 1 BOTTLE (65862-207-68)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 17, 2009	TE:	AB	RLD:	No

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