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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Zoledronate
Trade Name: Zometa, Zabel
Date Designated: 08/18/2000
Orphan Designation: Treatment of tumor induced hypercalcemia.
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corp.
59 Route 10
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Zoledronate
Trade Name: Zometa, Zabel
Marketing Approval Date: 08/20/2001
Approved Labeled Indication: Treatment of hypercalcemia of malignancy.
Exclusivity End Date: 08/20/2008 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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