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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: chlorobutanol/propylene glycol/hydrochloric acid
Date Designated: 02/18/1997
Orphan Designation: Treatment of patulous eustachian tube
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Ear Foundation
2420 Castillo Street, Suite 100
Santa Barbara, California 93105
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.