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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Buffered intrathecal electrolyte/dextrose injection
Trade Name: Elliotts B Solution
Date Designated: 08/24/1994
Orphan Designation: For use as a diluent in the intrathecal administration of methotrexate and cytarabine for the prevention or treatment meningeal leukemia and lymphocytic lymphoma
Orphan Designation Status: Designated/Approved
Lukare Medical, LLC
4 Julia Court
P. O. Box 782
Scotch Plains, New Jersey 07076
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Buffered intrathecal electrolyte/dextrose injection
Trade Name: Elliotts B Solution
Marketing Approval Date: 09/27/1996
Approved Labeled Indication: For the intrathecal administration of methotrexate and cytarabine for the prevention or treatment of meningeal leukemia and lymphocytic lymphoma.
Exclusivity End Date: 09/27/2003 
Exclusivity Protected Indication* :  

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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