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2005P-0498:
Criteria of Generic Version of Wellbutrin XL (bupropion hydrochloride
extended-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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| 12/20/2005
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| 12/20/2005
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| Private Industry
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| Keller and Heckman
LLP
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| Table
of Contents
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| Signature:
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| John B. Dubeck
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| ACK1
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| 12/20/2005
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| 12/20/2005
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| Federal Government
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| HFA-305 to Keller
and Heckman LLP
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| EC1
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| 02/02/2006
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| 01/03/2006
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| Individual Consumer
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| Mr. Dave Lowe
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| htm,
Attachment
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| EC2
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| 02/02/2006
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| 01/16/2006
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| Individual Consumer
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| Mr. Dave Lowe
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| htm,
Attachment
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| EC3
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| 02/02/2006
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| 01/19/2006
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| Individual Consumer
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| Mr. Dave Lowe
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| htm
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| EC4
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| 02/08/2006
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| 02/03/2006
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| International
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| Dr. Nadir Nugasha
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| htm
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| C1
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| 02/24/2006
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| 02/24/2006
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| Drug Industry
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| Impax Laboratories,
Inc.
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| pdf
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| Signature:
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| James N. Cazaban
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| LET1
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| 06/12/2006
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| 06/12/2006
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| Federal Government
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| FDA/CDER to Keller
and Heckman LLP
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| pdf
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| Signature:
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| Jane A. Axelrad
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| LET2
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| 06/29/2006
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| 06/29/2006
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| Private Industry
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| Keller and Heckman
LLP
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| pdf
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| Signature:
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| John B. Dubeck
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| PAV1
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| 12/18/2006
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| 12/18/2006
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| Federal Government
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| FDA to Keller & Heckman
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| pdf
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| Signature:
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| Randall W. Lutter, PhD
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Top | Up Page last updated:
January 29, 2007
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