| Up
2004D-0524:
DRAFT GUIDANCE FOR INDUSTRY ON ANDAS: PHARMACEUTICAL SOLID POLYMORPHISM;
CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION
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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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| 12/17/2004
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| 12/17/2004
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| Federal
Government
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| Guidance
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| pdf
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| Signature:
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| Guidance
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| NAD1
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| 12/17/2004
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| FDA
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| FDA
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| 12/20/2004
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| 75987-75988
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| 03/21/2005
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EC1
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| 03/03/2005
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| 03/02/2005
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| Drug Industry
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| Eon Labs,
Inc.
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| htm,
Attachment
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| Signature:
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| Upadhye, Shashank
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| EC2
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| 03/09/2005
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| 03/09/2005
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| Drug Industry
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| Teva Pharmaceutical
Industries Ltd.
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| htm
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| Signature:
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| Rotem, Nava
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| C1
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| 03/08/2005
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| 03/01/2005
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| Drug Industry
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| Eon Labs
Inc
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| pdf
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| Signature:
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| Shashank Upadhye,
Esq
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| EMC1
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| 03/09/2005
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| 03/09/2005
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| Drug Industry
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| Teva Pharmaceutical
Industries, Ltd. (TEVA)
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| pdf
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| Signature:
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| Nava Rotem
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| C2
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| 03/15/2005
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| 03/14/2005
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| Private
Industry
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| AstraZeneca
LP
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| pdf
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| Signature:
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| Lan-Chi Nguyen
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| C3
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| 03/17/2005
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| 03/17/2005
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| Drug Industry
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| Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals
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| pdf
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| Signature:
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| Steve Caffe, MD
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| C4
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| 03/21/2005
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| 03/21/2005
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| Drug Industry
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| GlaxoSmithKline
(GSK)
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| pdf
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| Signature:
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| Patrick J. Crowley
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| C5
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| 03/24/2005
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| 03/21/2005
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| Drug Industry
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| GlaxoSmithKline
(GSK)
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| pdf
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| Signature:
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| Mary Faye S. Whisler,
PhD
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| EC3
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| 03/22/2005
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| 03/21/2005
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| Other Organization
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| Greenblum
and Bernstein PLC
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| htm,
Attachment
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| Signature:
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| Braier, PhD, JD, Paul
A.
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| EC4
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| 03/22/2005
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| 03/21/2005
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| Drug Industry
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| Apotex Inc.
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| htm
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| Signature:
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| Docherty, Jennifer
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| EC5
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| 03/22/2005
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| 03/21/2005
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| Drug Association
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| Generic
Pharmaceutical Association
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| htm,
Attachment
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| Signature:
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| Johnston, Gordon
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| EMC2
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| 03/29/2005
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| 03/29/2005
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| Individual
Consumer
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| Teva Pharmaceutical
Industries Ltd
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| txt,
Attachment
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| Signature:
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| Nava Rotem
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Top
| Up
Page last updated
April 4, 2005
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