Search Orphan Drug Designations and Approvals
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Generic Name: | ribavirin | ||||||||||||||||
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Trade Name: | REBETOL | ||||||||||||||||
Date Designated: | 04/04/2003 | ||||||||||||||||
Orphan Designation: | Treatment of chronic hepatitis C in pediatric patients | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Schering Corporation 2000 Galloping Hill Road Kenilworth, New Jersey 07033 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | ribavirin |
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Trade Name: | REBETOL | |
Marketing Approval Date: | 07/29/2003 | |
Approved Labeled Indication: | Treatment of chronic hepatitis C among previously untreated pediatric patients at least three years of age or older. | |
Exclusivity End Date: | 07/29/2010 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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