Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: sodium sulfate, potassium sulfate, and magnesium sulfate
Trade Name: SUPREP Bowel Prep Kit
Date Designated: 10/31/2012
Orphan Designation: For cleansing of the colon in preparation for colonoscopic diagnosis of colonic disease in children and adolescents
Orphan Designation Status: Designated/Approved
Braintree Laboratories, Inc.
60 Columbian Street West
PO Box 850929
Braintree, Massachusetts 02185
United States

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

Marketing approved:

1 Generic Name: sodium sulfate, potassium sulfate, and magnesium sulfate
Trade Name: SUPREP Bowel Prep Kit
Marketing Approval Date: 08/05/2020
Approved Labeled Indication: for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older
Exclusivity End Date: 08/05/2027 
Exclusivity Protected Indication* :  for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-