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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: Genotropin
Date Designated: 09/06/1994
Orphan Designation: Treatment of adults with growth hormone deficiency.
Orphan Designation Status: Designated/Approved
Pharmacia & Upjohn
7000 Portage Road
Kalamazoo, Michigan 49001
United States

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

Marketing approved:

1 Generic Name: Somatropin
Trade Name: Genotropin
Marketing Approval Date: 10/31/1997
Approved Labeled Indication:
Exclusivity End Date: 10/31/2004 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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