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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Cromolyn sodium
Trade Name: Gastrocrom
Date Designated: 03/08/1984
Orphan Designation: Treatment of mastocytosis.
Orphan Designation Status: Designated/Approved
Fisons Corporation
755 Jefferson Rd., P.O. Box 1710
Rochester, New York 14603
United States

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

Marketing approved:

1 Generic Name: Cromolyn sodium
Trade Name: Gastrocrom
Marketing Approval Date: 12/22/1989
Approved Labeled Indication:
Exclusivity End Date: 12/22/1996 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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