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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. Twelve suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ribavirin profile page.

Summary for NDA: 079117

Tradename:
RIBAVARIN
Applicant:
Aurobindo Pharma
Ingredient:
ribavirin
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 079117

Ingredient-typeNucleoside Analog

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)

Summary for product number 001

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


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