| Up
2004D-0460:
GUIDANCE FOR INDUSTRY ON LISTED DRUGS, 30-MONTH STAYS, AND APPROVAL
OF ANDAS AND 505(B)(2) APPLICATIONS UNDER HATCH-WAXMAN, AS AMENDED
BY THE MEDICARE PRESCRIPTION DRUG, IMPROVEMENT, AND MODERNIZATION
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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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| Volume
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| Remarks
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| GDL1
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| 11/03/2004
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| 11/03/2004
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| Federal
Government
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| Guideline
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| doc,
pdf
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| Signature:
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| Guideline
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| NAD1
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| 11/03/2004
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| FDA
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| FDA
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| 02/05/2005
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| pdf
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| Signature:
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| JEFFREY SHUREN
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| NCR1
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| 11/18/2004
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| FDA
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| FDA
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| 11/21/2005
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| pdf
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| Signature:
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| Jeffrey Shuren
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| EC1
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| 12/22/2004
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| 12/22/2004
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| Individual Consumer
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| Mr. Bruce DeVoid
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| htm
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| Signature:
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| DeVoid, Bruce
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| EC2
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| 01/14/2005
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| 01/13/2005
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| Individual Consumer
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| Mr. Robert Baldwin
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| htm
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| Signature:
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| Baldwin, Robert
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| EC3
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| 02/08/2005
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| 02/07/2005
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| Individual Consumer
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| Mr. Peter Ritz
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| htm
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| Signature:
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| Ritz, Peter
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| EMC1
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| 02/02/2005
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| 02/02/2005
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| Drug Industry
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| Apotex, Inc.
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| 1
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| Signature:
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| Jennifer Docherty
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| EC4
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| 02/13/2005
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| 02/12/2005
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| Dietary
Supplement Industry
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| BATRA MEDICOS
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| htm
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| Signature:
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| BATRA, RAJEEV
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Page last updated
February 28, 2005
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