2004P-0140:
Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone
Labeling
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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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| CP1
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| 03/19/2004
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| 03/19/2004
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| Private Industry
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| King Pharmaceuticals,
Inc.
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| Table
of Contents
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| Signature:
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| Peter R. Mathers
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| ACK1
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| 03/19/2004
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| 03/19/2004
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| Federal Government
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| HFA-305 to King Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Gloria Ortega
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| PSA1
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| 03/19/2004
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| 03/19/2004
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| Private Industry
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| King Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Peter R. Mathers
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| ACK2
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| 03/19/2004
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| 03/19/2004
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| Federal Government
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| HFA-305 to King Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Gloria Ortega
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| LET1
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| 04/01/2004
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| 03/31/2004
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| Drug Industry
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| Corepharma, LLC
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| pdf
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| Signature:
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| Patricia J. Thompson
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| PSA2
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| 04/05/2004
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| 04/06/2004
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| Private Industry
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| Mutual Pharmaceutical
Co., Inc.
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| pdf
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| Signature:
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| James N. Czaban
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| ACK3
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| 04/07/2004
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| 04/07/2004
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| Federal Government
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| HFA-305 to Mutual
Pharmaceutical Co., Inc.
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| EMC1
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| 03/31/2004
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| 03/31/2004
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| Drug Industry
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| Corepharma, LLC
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| pdf
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| Signature:
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| Patricia J. Thompson
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| SUP1
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| 04/16/2004
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| 04/15/2004
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| Drug Industry
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| King Pharmaceuticals,
Inc.
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| pdf
Exhibits
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| Signature:
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| Peter R. Mathers
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| EMC2
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| 04/30/2004
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| 04/30/2004
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| Drug Industry
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| Corepharma, LLC (Corepharma)
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| pdf
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| Signature:
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| Patricia J. Thompson
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| C1
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| 05/03/2004
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| 05/03/2004
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| Drug Industry
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| Corepharma, LLC (Corepharma)
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| Table
of Contents
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| Signature:
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| Patricia J. Thompson
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| EMC3
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| 05/14/2004
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| 05/13/2004
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| Drug Industry
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| King Pharmaceuticals,
Inc
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| pdf
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| Signature:
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| Peter R Mathers
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| SUP2
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| 05/17/2004
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| 05/17/2004
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| Drug Industry
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| Mutual Pharmaceutical
Co., Inc
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| Table
of Contents
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| Signature:
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| James N Czaban
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| SUP3
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| 07/21/2004
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| 07/21/2004
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| Drug Industry
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| King Pharmaceuticals,
Inc.
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| Table
of Contents
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| Signature:
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| Peter R. Mathers
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| LET2
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| 09/10/2004
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| 09/10/2004
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| Federal Government
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| HFD-005 to Kleinfeld,
Kaplan and Becker, LLP
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| pdf
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| Signature:
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| Jane A. Axelrad
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| SUP4
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| 02/15/2005
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| 02/15/2005
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| Drug Industry
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| Mutual Pharmaceutical
Co., Inc. (Mutual)
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| pdf
Attached CV
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| Signature:
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| Daniel L. Azarnoff, MD
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| SUP5
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| 12/08/2005
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| 12/08/2005
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| Drug Industry
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| Mutual Pharmaceutical
Co., Inc. (Mutual)
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| Table
of Contents
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| Signature:
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| William B. Schultz
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| SUP6
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| 02/13/2007
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| 02/13/2007
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| Private Industry
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| King Pharmaceuticals,
Inc.
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| Table
of Contents
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| Signature:
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| Peter Mathers
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| SUP7
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| 05/02/2007
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| 05/02/2007
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| Private Industry
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| Mutual Pharmaceutical
Co., Inc
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| Table
of Contents
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| Signature:
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| William B Schultz
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Top
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Page last updated:
July 11, 2007
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