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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Lidocaine patch 5%
Trade Name: Lidoderm Patch
Date Designated: 10/24/1995
Orphan Designation: For relief of allodynia (painful hypersensitivity), and chronic pain in postherpetic neuralgia.
Orphan Designation Status: Designated/Approved
Teikoku Pharma USA, Inc.
745-D Camden Ave.
Campbell, California 95008
United States

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

Marketing approved:

1 Generic Name: Lidocaine patch 5%
Trade Name: Lidoderm Patch
Marketing Approval Date: 03/19/1999
Approved Labeled Indication:
Exclusivity End Date: 03/19/2006 
Exclusivity Protected Indication* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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