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2003N-0205: Exocrine Pancreatic Insufficiency Drug Products
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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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| BKG1
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| 04/27/2004
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| 04/27/2004
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| Federal
Government
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| Background Information
Refs 1 - 18
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| pdf, References,
Copyrighted Material
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| Signature:
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| Background Information Refs 1 -
18
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| N1
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| 04/27/2004
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| FDA
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| FDA
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| 04/28/2004
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| 23410-23414
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| pdf
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| Eff: April
28, 2004; petitions due June 28, 2004
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| Signature:
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| SHUREN, JEFFREY
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| C1
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| 06/23/2004
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| 06/21/2004
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| Drug Industry
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| Scientific Protein
Laboratories, LLC
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| pdf
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| Signature:
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| Christine E. Kois
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| C2
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| 06/25/2004
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| 06/24/2004
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| Drug Industry
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| Digestive Care,
Inc.
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| pdf
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| Signature:
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| Tibor Sipos, Ph.D
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| N2
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| 10/26/2007
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| FDA
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| FDA
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| 10/26/2007
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| 60860-60862
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| pdf
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| Signature:
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| Jeffrey Shuren
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Top | Up
Page last updated:
October 31, 2007
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