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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ciprofloxacin DPI
Date Designated: 02/02/2010
Orphan Designation: Management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/07/2018
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bayer HealthCare Pharmaceuticals, Inc.
P. O. Box 1000
Montville, New Jersey 07045
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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