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Generated: May 29, 2017

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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, Zydus Pharms Usa, Sandoz, Sandoz Inc, Teva, Kadmon Pharms Llc, and Navinta Llc, and is included in ten NDAs. It is available from eleven 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. Fifteen suppliers are listed for this compound. Additional details are available on the ribavirin profile page.

Summary for NDA: 079111

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 079111

Ingredient-typeNucleoside Analog

Suppliers and Packaging for NDA: 079111

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 17, 2009TE:ABRLD:No

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