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Generated: November 21, 2018

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Details for New Drug Application (NDA): 079117

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NDA 079117 describes RIBAVARIN, which is a drug marketed by Aurobindo Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the RIBAVARIN profile page.

The generic ingredient in RIBAVARIN 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
Ingredient-typeNucleoside Analog
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
RIBAVARIN ribavirin CAPSULE;ORAL 079117 ANDA Aurobindo Pharma Limited 65862-290 65862-290-39 3000 CAPSULE in 1 BAG (65862-290-39)
RIBAVARIN 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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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Queensland Health

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