Details for New Drug Application (NDA): 077094

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 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 077094

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

Pharmacology for NDA: 077094

Medical Subject Heading (MeSH) Categories for 077094

Antimetabolites

Antiviral Agents

Suppliers and Packaging for NDA: 077094

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIBAVIRIN	ribavirin	TABLET;ORAL	077094	ANDA	Zydus Lifesciences Limited	65841-046	65841-046-03	168 TABLET, FILM COATED in 1 BOTTLE (65841-046-03)
RIBAVIRIN	ribavirin	TABLET;ORAL	077094	ANDA	Zydus Lifesciences Limited	65841-046	65841-046-10	1000 TABLET, FILM COATED in 1 BOTTLE (65841-046-10)

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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