Search Orphan Drug Designations and Approvals
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Generic Name: | Glutamine | ||||||||||||||||
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Trade Name: | NutreStore | ||||||||||||||||
Date Designated: | 03/06/1995 | ||||||||||||||||
Orphan Designation: | For use with human growth hormone in the treatment of short bowel syndrome (nutrient malabsorption from the gastrointestinal tract resulting from an inadequate absorptive surface). | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Emmaus Medical, Inc. 20725 S. Western Avenue Suite 136 Torrence, California 90501 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: | Glutamine |
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Trade Name: | NutreStore | |
Marketing Approval Date: | 06/10/2004 | |
Approved Labeled Indication: | Treatment of short bowel syndrome in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication. | |
Exclusivity End Date: | 06/10/2011 | |
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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