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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Carmustine
Date Designated: 07/03/2000
Orphan Designation: Treatment of intracranial malignancies.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Direct Therapeutics, Inc.
460 Seaport Court
Suite 220
Redwood, California 94063
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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