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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 079117

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NDA 079117 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 079117

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

Pharmacology for NDA: 079117

Medical Subject Heading (MeSH) Categories for 079117

Antimetabolites
Antiviral Agents

Suppliers and Packaging for NDA: 079117

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RIBAVIRIN	ribavirin	CAPSULE;ORAL	079117	ANDA	Aurobindo Pharma Limited	65862-290	65862-290-05	500 CAPSULE in 1 BOTTLE (65862-290-05)
RIBAVIRIN	ribavirin	CAPSULE;ORAL	079117	ANDA	Aurobindo Pharma Limited	65862-290	65862-290-18	180 CAPSULE in 1 BOTTLE (65862-290-18)

Profile for product number 001

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

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