Search Orphan Drug Designations and Approvals
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Generic Name: | Tiotropium bromide |
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Date Designated: | 01/08/2008 |
Orphan Designation: | To improve pulmonary function in conjunction with standard therapy in the management of patients with cystic fibrosis |
Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
Date Designation Withdrawn or Revoked: | 05/23/2019 |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Boehringer Ingelheim Pharmaceuticals, Inc. P. O. Box 368 900 Ridgebury Road Ridgefield, Connecticut 06877 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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