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2006P-0405:
Require Full Prescribing Information of all Antiepileptic Drugs
Contain Specific Language under Warnings or Warnings and Precautions
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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ACK1 |
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10/03/2006
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10/03/2006
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Federal Government |
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FDA/DDM to UCB,
Inc |
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pdf |
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Signature: |
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Jennie C. Butler
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CP1 |
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10/03/2006
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10/03/2006
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Private Industry
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UCB, Inc
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Table
of Contents |
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Signature: |
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Egros Fabrice, Pharm. D.,
Ph.D. |
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| EMC1
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| 03/26/2007
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| 03/26/2007
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| Individual Consumer
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| S. Dickens
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| C1
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| 03/30/2007
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| 03/27/2007
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| State Government
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| Georgia House of Representatives
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| pdf
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| Signature:
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| Charlice Byrd
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| EC1
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| 04/03/2007
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| 03/22/2007
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| State Government
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| Kentucky General Assembly
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| htm
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| Signature:
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| Denton, Julie
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| EC2
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| 04/03/2007
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| 03/22/2007
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| Individual Consumer
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| Mrs. Margo Knight
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| EC3
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| 04/03/2007
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| 03/23/2007
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| Individual Consumer
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| Ms. Elizabeth Cooksey
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| EC4
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| 04/03/2007
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| 03/23/2007
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| Individual Consumer
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| Mrs. Michele Gasaway
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| EC5
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| 04/03/2007
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| 03/23/2007
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| Individual Consumer
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| Ms. Audrey Autrey
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| EC6
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| 04/03/2007
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| 03/24/2007
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| Individual Consumer
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| Mr. Bill Draper
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| EC7
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| 04/03/2007
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| 03/26/2007
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| Health Professional
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| Children's Epilepsy
Center
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| htm
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| Signature:
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| Braden, Kathy
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| EC8
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| 04/03/2007
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| 03/26/2007
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| Individual Consumer
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| Miss. Ashley Baldwin
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| EC9
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| 04/03/2007
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| 03/27/2007
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| Individual Consumer
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| Mrs. Robin Cox
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| EC10
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| 04/03/2007
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| 03/28/2007
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| Individual Consumer
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| Ms. Caroline Morais
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| EC11
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| 04/03/2007
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| 03/28/2007
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| Individual Consumer
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| Mrs. Sheila Blanton
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| LET1
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| 04/05/2007
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| 04/05/2007
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| Federal Government
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| FDA/CDER to UCB Inc
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| pdf
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| Signature:
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| Jane A Axelrad
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| C2
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| 04/23/2007
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| 04/18/2007
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| State Government
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| Minnesota House of
Representatives
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| pdf
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| Signature:
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| Jim Abeler
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| C3
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| 05/15/2007
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| 05/14/2007
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| Private Industry
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| Mylan Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Russell J. Rackley, Ph.D.
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| C4
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| 06/29/2007
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| 06/26/2007
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| Private Industry
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| People's Medical Society
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| pdf
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| Signature:
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| Charles B. Inlander
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| C5
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| 06/29/2007
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| 06/29/2007
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| Individual Consumer
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| W. R. Rowley, MD
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Top | Up Page last updated:
July 6, 2007
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