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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Morphine sulfate concentrate (preservative free)
Trade Name: Infumorph
Date Designated: 07/12/1990
Orphan Designation: For use in microinfusion devices for intraspinal administration in the treatment of intractable chronic pain.
Orphan Designation Status: Designated/Approved
Elkins-Sinn, Inc.
2 Esterbrook Lane
Cherry Hill, New Jersey 08003
United States

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

Marketing approved:

1 Generic Name: Morphine sulfate concentrate (preservative free)
Trade Name: Infumorph
Marketing Approval Date: 07/19/1991
Approved Labeled Indication: For intrathecal or epidural infusion in the treatment of tractable chronic pain. It was developed for use in continuous microinfusion devices and may require dilution before use as directed.
Exclusivity End Date: 07/19/1998 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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