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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: propranolol
Trade Name: HEMANGEOL
Date Designated: 09/05/2008
Orphan Designation: Treatment of proliferating infantile hemangiomas requiring systemic therapy
Orphan Designation Status: Designated/Approved
Pierre Fabre Dermatologie
8 Campus Drive, 2nd Floor
Parsippany, New Jersey 07054
United States

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

Marketing approved:

1 Generic Name: propranolol
Trade Name: HEMANGEOL
Marketing Approval Date: 03/14/2014
Approved Labeled Indication: Treatment of proliferating infantile hemangioma requiring systemic therapy.
Exclusivity End Date: 03/14/2021 
Exclusivity Protected Indication* :  Treatment of proliferating infantile hemangioma requiring systemic therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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