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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: meloxicam
Trade Name: Mobic
Date Designated: 11/22/2002
Orphan Designation: Treatment of juvenile rheumatoid arthritis
Orphan Designation Status: Designated/Approved
Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road
P. O. Box 368
Ridgefield, Connecticut 06877
United States

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

Marketing approved:

1 Generic Name: meloxicam
Trade Name: Mobic
Marketing Approval Date: 08/11/2005
Approved Labeled Indication: For relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age or older
Exclusivity End Date: 08/11/2012 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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