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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: azithromycin
Date Designated: 06/06/2022
Orphan Designation: Prevention of bronchopulmonary dysplasia in neonates.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Iorek Pharma Limited
102 High Street
GODALMING, England GU7 1DS
United Kingdom

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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