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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Metronidazole (topical)
Trade Name: Metrogel
Date Designated: 10/22/1987
Orphan Designation: Treatment of acne rosacea.
Orphan Designation Status: Designated/Approved
Galderma Laboratories, Inc.
P.O. Box 331329
Fort Worth, Texas 76163
United States

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

Marketing approved:

1 Generic Name: Metronidazole (topical)
Trade Name: Metrogel
Marketing Approval Date: 11/22/1988
Approved Labeled Indication:
Exclusivity End Date: 11/22/1995 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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