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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: aspirin for injection (acetylsalicylic acid)
Date Designated: 09/18/2020
Orphan Designation: Treatment of Kawasaki Disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Rhoshan Pharmaceuticals Inc.
19 Colonnade Way, Suite 117, Box 141
State College, Pennsylvania 16803
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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