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2004P-0320: REFRAIN FROM APPROVING CERTAIN APPLICATIONS SUBMITTED UNDER SECTION 505(B)(2) OF THE FDCA THAT REFERENCE DEPAKOTE (DIVALPROEX SODIUM DELAYED- RELEASE TABLETS)
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 07/15/2004 07/15/2004 Drug Industry Abbott Laboratories       pdf, Tab1, Tab2, Tab3, Tab4, Tab5  
Signature: David M. Fox
ACK1 07/15/2004 07/15/2004 Federal Government
HFA-305 to Abbott Laboratories       doc, pdf  
Signature: Jennie C. Butler
LET1 08/03/2004 08/03/2004 Drug Industry Abbott Laboratories       pdf  
Signature: David M. Fox
C1 11/01/2004 10/29/2004 Drug Industry Andrx Laboratories, Inc. (Andrx)       pdf  
Signature: David L. Rosen, B.S.Pharm.,J.D.
LET2 01/12/2005 01/12/2005 Federal Government
HFD-005 to Hogan & Hartson       pdf  
Signature: Jane A. Axelrad
RC1 03/04/2005 03/04/2005 Drug Industry Abbott Laboratories       pdf  
Signature: David M. Fox
WDL1 07/21/2006 07/21/2006 Drug Industry Abbott Laboratories       pdf  
Signature: David M Fox

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Page last updated August 10, 2006 kk

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