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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Somatropin
Trade Name: Nutropin
Date Designated: 03/06/1987
Orphan Designation: For use in the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.
Orphan Designation Status: Designated/Approved
Genentech, Inc.
460 Point San Bruno Boulevard
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: Somatropin
Trade Name: Nutropin
Marketing Approval Date: 10/17/1985
Approved Labeled Indication:
Exclusivity End Date: 10/17/1992 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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