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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.
225 Wilmington-West Chester Pike, Suite 200
Chadds Ford, Pennsylvania 19317
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.