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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Hydroxocobalamin
Trade Name: Cyanokit
Date Designated: 11/25/2003
Orphan Designation: Treatment of acute cyanide poisoning
Orphan Designation Status: Designated/Approved
SERB, S.A.
480 Avenue Louise
Brussels, Brussels
Belgium

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

Marketing approved:

1 Generic Name: Hydroxocobalamin
Trade Name: Cyanokit
Marketing Approval Date: 12/15/2006
Approved Labeled Indication: Treatment on known or suspected cyanide poisoning
Exclusivity End Date: 12/15/2013 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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