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2006P-0522:
Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product Using Lidoderm as its RLD
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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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| 12/18/2006
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| 12/18/2006
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| Private Industry
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| Endo Pharmaceuticals
Inc
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| Table
of Contents
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| Signature:
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| Roland Ferritsen van der Hoop
MD Ph
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| ACK1
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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/DDM to Endo Pharmaceuticals
Inc
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| pdf
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| Signature:
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| Jennie Butler
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| CR1
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| 12/20/2006
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| 12/19/2006
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| Drug Industry
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| Endo Pharmaceuticals
Inc
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| pdf
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| Signature:
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| Caroline B Manogue
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| CR2
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| 12/21/2006
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| 12/21/2006
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| Federal Government
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| FDA/DDM to Endo Pharmaceuticals
Inc
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| pdf
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| Signature:
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| Jennie Butler
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| EC1
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| 12/28/2006
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| 12/27/2006
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| Individual Consumer
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| Mr. Dave Lowe
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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 Endo Pharmaceuticals
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| pdf
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| Signature:
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| Jane A. Axelrad
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| AMD1
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| 08/30/2007
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| 08/30/2007
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| Private Industry
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| Endo Pharmaceuticals,
Inc.
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| Table
of Contents
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| Contact for petition
is Mary Alice Raudenbush.
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| Signature:
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| Mary Alice Raudenbush
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Top | Up Page last updated:
September 10, 2007
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