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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Technetium Tc99m sulfur colloid injection, lyophilized
Trade Name: Technetium Tc99m Sulfur Colloi
Date Designated: 03/17/2009
Orphan Designation: For localization of sentinel lymph nodes in patients with melanoma
Orphan Designation Status: Designated/Approved
Pharmalucence, Inc.
10 DeAngelo Drive
Bedford, Massachusetts 01730
United States

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

Marketing approved:

1 Generic Name: Technetium Tc99m sulfur colloid injection, lyophilized
Trade Name: Technetium Tc99m Sulfur Colloi
Marketing Approval Date: 08/13/2012
Approved Labeled Indication: Localization of lymph nodes draining a primary tumor in patients with melanoma when used with a hand-held gamma counter
Exclusivity End Date: 08/13/2019 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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