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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Sodium ascorbate and menadione sodium bisulfite
Date Designated: 07/31/2007
Orphan Designation: Treatment of metastatic or locally advanced inoperable transitional cell carcinoma of the urothelium (stage III and IV bladder cancer)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
IC-MedTech Corporation
9902 Indian Creek Lane
San Diego, California 92021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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