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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Ofloxacin
Trade Name: Ocuflox Ophthalmic Solution
Date Designated: 04/18/1991
Orphan Designation: Treatment of bacterial corneal ulcers.
Orphan Designation Status: Designated/Approved
Allergan, Inc.
2525 Dupont Drive
P.O. Box 19534
Irvine, California 92713
United States

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

Marketing approved:

1 Generic Name: Ofloxacin
Trade Name: Ocuflox Ophthalmic Solution
Marketing Approval Date: 05/22/1996
Approved Labeled Indication: Treatment of bacterial corneal ulcers.
Exclusivity End Date: 05/22/2003 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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