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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sodium sulfate, potassium sulfate, and magnesium sulfate; PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
Date Designated: 09/04/2013
Orphan Designation: For use in cleansing of the colon in preparation for colonoscopy in children and adolescents
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Braintree Laboratories, Inc.
60 Columbian Street West
P.O. Box 850929
Braintree, Massachusetts 02185
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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