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2004P-0140: Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
CP1 03/19/2004 03/19/2004 Private Industry King Pharmaceuticals, Inc.       Table of Contents  
Signature: Peter R. Mathers
ACK1 03/19/2004 03/19/2004 Federal Government HFA-305 to King Pharmaceuticals, Inc.       pdf  
  Signature: Gloria Ortega
PSA1 03/19/2004 03/19/2004 Private Industry King Pharmaceuticals, Inc.       pdf  
Signature: Peter R. Mathers
ACK2 03/19/2004 03/19/2004 Federal Government HFA-305 to King Pharmaceuticals, Inc.       pdf  
  Signature: Gloria Ortega
LET1 04/01/2004 03/31/2004 Drug Industry Corepharma, LLC       pdf  
Signature: Patricia J. Thompson
PSA2 04/05/2004 04/06/2004 Private Industry Mutual Pharmaceutical Co., Inc.       pdf  
Signature: James N. Czaban
ACK3 04/07/2004 04/07/2004 Federal Government HFA-305 to Mutual Pharmaceutical Co., Inc.       pdf  
  Signature: Lyle D. Jaffe
EMC1 03/31/2004 03/31/2004 Drug Industry Corepharma, LLC       pdf  
Signature: Patricia J. Thompson
SUP1 04/16/2004 04/15/2004 Drug Industry King Pharmaceuticals, Inc.       pdf
Exhibits
 
Signature: Peter R. Mathers
EMC2 04/30/2004 04/30/2004 Drug Industry Corepharma, LLC (Corepharma)       pdf  
Signature: Patricia J. Thompson
C1 05/03/2004 05/03/2004 Drug Industry Corepharma, LLC (Corepharma)       Table of Contents  
Signature: Patricia J. Thompson
EMC3 05/14/2004 05/13/2004 Drug Industry King Pharmaceuticals, Inc       pdf  
Signature: Peter R Mathers
SUP2 05/17/2004 05/17/2004 Drug Industry Mutual Pharmaceutical Co., Inc       Table of Contents  
Signature: James N Czaban
SUP3 07/21/2004 07/21/2004 Drug Industry King Pharmaceuticals, Inc.       Table of Contents  
Signature: Peter R. Mathers
LET2 09/10/2004 09/10/2004 Federal Government HFD-005 to Kleinfeld, Kaplan and Becker, LLP       pdf  
  Signature: Jane A. Axelrad
SUP4 02/15/2005 02/15/2005 Drug Industry Mutual Pharmaceutical Co., Inc. (Mutual)       pdf
Attached CV
 
Signature: Daniel L. Azarnoff, MD
SUP5 12/08/2005 12/08/2005 Drug Industry Mutual Pharmaceutical Co., Inc. (Mutual)       Table of Contents  
Signature: William B. Schultz
SUP6 02/13/2007 02/13/2007 Private Industry King Pharmaceuticals, Inc.       Table of Contents  
Signature: Peter Mathers
SUP7 05/02/2007 05/02/2007 Private Industry Mutual Pharmaceutical Co., Inc       Table of Contents  
Signature: William B Schultz

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Page last updated: July 11, 2007