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Last Updated: July 14, 2020

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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, Kadmon Pharms Llc, and Sandoz, and is included in eleven NDAs. It is available from five 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. Nine suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
Summary for 079111
Applicant:Aurobindo Pharma
Formulation / Manufacturing:see details
Pharmacology for NDA: 079111
Medical Subject Heading (MeSH) Categories for 079111
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:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 17, 2009TE:ABRLD:No

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