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Generated: April 24, 2019

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Details for New Drug Application (NDA): 079117

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NDA 079117 describes RIBAVIRIN, which is a drug marketed by Aurobindo Pharma, Casi Pharms Inc, Teva, Zydus Pharms Usa, Navinta Llc, Beximco Pharms Usa, Kadmon Pharms Llc, and Sandoz, and is included in eleven NDAs. It is available from ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
Summary for 079117
Applicant:Aurobindo Pharma
Formulation / Manufacturing:see details
Pharmacology for NDA: 079117
Medical Subject Heading (MeSH) Categories for 079117
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 65862-290-39 3000 CAPSULE in 1 BAG (65862-290-39)
RIBAVIRIN ribavirin CAPSULE;ORAL 079117 ANDA Aurobindo Pharma Limited 65862-290 65862-290-05 500 CAPSULE in 1 BOTTLE (65862-290-05)

Profile for product number 001

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

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