Search Orphan Drug Designations and Approvals
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Generic Name: | Clofazimine | ||||||||||||||||
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Trade Name: | Lamprene | ||||||||||||||||
Date Designated: | 06/11/1984 | ||||||||||||||||
Orphan Designation: | Treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Novartis Pharmaceutical Corporation 59 Route 10 East Hanover, New Jersey 07936 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Clofazimine |
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Trade Name: | Lamprene | |
Marketing Approval Date: | 12/15/1986 | |
Approved Labeled Indication: | ||
Exclusivity End Date: | 12/15/1993 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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