Generic NameTrade NameDate DesignatedOrphan DesignationOrphan Designation StatusDate Designation Withdrawn or RevokedFDA Orphan Approval StatusApproved Labeled IndicationMarketing Approval DateExclusivity End DateExclusivity Protected Indication * (Shown on labeling)Sponsor CompanySponsor Address 1Sponsor Address 2Sponsor CitySponsor StateSponsor ZipSponsor CountryCF Grid Key
Eflornithine hydrochloride 03/11/2024Treatment of Bachmann-Bupp syndromeDesignated Not FDA Approved for Orphan Indication    Provider-shaped sponsor     US992323