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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: multi-vitamin infusion without vitamin K
Trade Name: M.V.I.-12
Date Designated: 03/08/2004
Orphan Designation: Prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition and warfarin-type anticoagulant therapy
Orphan Designation Status: Designated/Approved
Mayne Pharma (USA) Inc.
Mack-Cali Centre II
Second Floor
Paramus, New Jersey 07652
United States

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

Marketing approved:

1 Generic Name: multi-vitamin infusion without vitamin K
Trade Name: M.V.I.-12
Marketing Approval Date: 09/09/2004
Approved Labeled Indication: Prevention of vitamin deficiency and thrombormbolic complications in people receiving home parenteral nutrition who also receive warfarin-type anticoagulant therapy
Exclusivity End Date: 09/09/2011 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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