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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)
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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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| 07/15/2004
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| 07/15/2004
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| Drug Industry
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| Abbott Laboratories
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| pdf,
Tab1, Tab2,
Tab3, Tab4,
Tab5
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| Signature:
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| David M. Fox
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| ACK1
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| 07/15/2004
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| 07/15/2004
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| Federal
Government
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| HFA-305 to Abbott
Laboratories
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| doc,
pdf
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| Signature:
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| Jennie C. Butler
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| LET1
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| 08/03/2004
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| 08/03/2004
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| Drug Industry
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| Abbott Laboratories
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| pdf
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| Signature:
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| David M. Fox
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| C1
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| 11/01/2004
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| 10/29/2004
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| Drug Industry
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| Andrx Laboratories,
Inc. (Andrx)
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| pdf
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| Signature:
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| David L. Rosen, B.S.Pharm.,J.D.
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| LET2
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| 01/12/2005
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| 01/12/2005
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| Federal
Government
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| HFD-005 to Hogan &
Hartson
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| pdf
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| Signature:
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| Jane A. Axelrad
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| RC1
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| 03/04/2005
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| 03/04/2005
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| Drug Industry
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| Abbott Laboratories
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| pdf
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| Signature:
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| David M. Fox
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| WDL1
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| 07/21/2006
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| 07/21/2006
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| Drug Industry
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| Abbott Laboratories
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| pdf
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| Signature:
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| David M Fox
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Top | Up
Page last updated
August 10, 2006
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