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2006P-0523:
Require ANDA applicant for generic of Eloxatin solution as reference
drug to perform clinical testing
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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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| 12/20/2006
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| 12/20/2006
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| Private Industry
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| Sanofi-aventis US
LLP
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| Table
of Contents
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| Signature:
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| Mark Moyer
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| ACK1
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| 12/20/2006
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| 12/20/2006
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| Federal Government
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| FDA/DDM to Sanofi-aventis
US LLP
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| pdf
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| Signature:
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| Jennie C. Butler
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| SUP1
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| 04/25/2007
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| 04/25/2007
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| Private Industry
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| Sanofi-aventis U.S
LLC
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| Table
of Contents
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| Signature:
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| Mark Moyer
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| LET1
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| 06/15/2007
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| 06/15/2007
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| Federal Government
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| FDA/CDER to Sanofi
Aventis US LLC
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| pdf
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| Signature:
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| Jane A. Axelrad
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Top | Up Page last updated:
July 11, 2007
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