Search Orphan Drug Designations and Approvals
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| Generic Name: | Buffered intrathecal electrolyte/dextrose injection | ||||||||||||||||
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| 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 | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 1 | Generic Name: | Buffered intrathecal electrolyte/dextrose injection |
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| 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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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