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2006P-0255:
Food and Drug Administration to Make a Determination that the Discontinued
Formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1
g was not Discontinued for Safety and Efficacy Reasons
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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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| 06/19/2006
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| 06/20/2006
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| Health Professional
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| Orchid Healthcare
(A Division of Orchid Chemicals & Pharmaceuticals Ltd)
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| Table
of Contents
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| Signature:
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| Imtiyaz Basade
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| ACK1
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| 06/20/2006
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| 06/20/2006
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| Federal Government
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| HFA-305 to Orchid
Healthcare
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| LET1
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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/CDER to Orchid
Healthcare
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| pdf
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| Signature:
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| Jane A. Axelrad
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| N1
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| 03/23/2007
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| FDA
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| FDA
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| 03/26/2007
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| 14118-14118
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| txt
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| Signature:
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| Jeffrey Shuren
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| ANS1
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| 03/29/2007
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| 03/29/2007
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| Federal Government
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| FDA/CDER to Orchid
Healthcare
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| pdf
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| Signature:
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| Mary Catchings
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Top | Up Page last updated:
April 18, 2007
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