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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-acetylcysteinate Lysine
Date Designated: 12/27/2000
Orphan Designation: For the management of cystic fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Galephar Pharmaceutical Research, Inc.
Road 198, No. 100 km. 14.7
Juncos Industrial Park
Juncos
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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