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2005P-0146:
To Establish Guidance or Regulations Providing Bioequivalence Requirement
for Oral Locally-acting Gastrointestinal (GI) Drug Products Prior
to Approval of any Generic Versions of Such Drugs
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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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| 04/13/2005
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| 04/14/2005
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| Drug Industry
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| Salix Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Stephen D. Celestini
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| ACK1
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| 04/14/2005
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| 04/14/2005
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| Federal Government
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| HFA-305 to Salix Pharmaceuticals,
Inc.
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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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| 10/13/2005
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| 10/13/2005
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| Federal Government
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| HFD-005 to Salix Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Jane A. Axelrad
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| SUP1
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| 07/14/2006
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| 07/14/2006
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| Drug Industry
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| Salix Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Stephen D. Celestini
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| SUP2
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| 11/14/2006
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| 11/14/2006
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| Drug Industry
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| Salix Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| William P. Forbes, PharmD
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| SUP3
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| 06/15/2007
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| 06/14/2007
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| Drug Industry
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| Sanx Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| William P. Forbes, Pharm. D.
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| SUP4
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| 09/27/2007
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| 09/27/2007
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| Drug Industry
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| Salix Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| William P. Forbes
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| PDN1
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| 01/03/2008
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| 01/03/2008
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| Federal
Government
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| FDA/CDER to Salix
Pharmaceuticals, Inc.
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| pdf
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| Signature:
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| Janet Woodcock, M.D.
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Top
| Up
Page last updated:
January 3, 2008
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