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2004D-0283:
WAIVERS OF IN VIVO DEMONSTRATION
OF BIOEQUIVALENCE OF ANIMAL DRUGS IN SOLUBLE POWDER ORAL DOSAGE
FORM PRODUCTS AND TYPE A MEDICATED ARTICLES
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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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| GDL1
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| 08/03/2004
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| 08/03/2004
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| Federal
Government
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| Guidance
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| pdf,
doc
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| Signature:
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| Guidance
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| NAD1
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| 08/02/2004
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| FDA
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| FDA
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| 08/03/2004
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| 46553-46555
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| 10/15/2004
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| pdf
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| Signature:
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| Jeffrey Shuren
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| EXT1
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| 09/15/2004
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| 09/14/2004
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| Association
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| Animal Health Institute
(AHI)
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| pdf
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| Signature:
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| Alexander S. Mathews
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Page last updated March 16, 2004 kk |
