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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  mesalamine and N-acetycysteine
Date Designated:  09/10/2009
Orphan Designation:  Treatment of pediatric patients with ulcerative colitis (inclusive through age 16 years)
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Altheus Therapeutics, Inc.
755 Research Parkway
Suite 435
Oklahoma City, Oklahoma 73104
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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