| Up
2005P-0420:
Establish Therapeutic Equivalence Requirements for any Generic or
Following-on Drug Product Referencing Adderall XR MASP
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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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| 10/18/2005
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| 10/18/2005
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| Private Industry
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| Shire Pharmaceuticals
Group
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| Table
of Contents
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| Signature:
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| Eliseo O. Salinas
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| ACK1
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| 10/19/2005
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| 10/19/2005
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| Federal Government
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| HFA-305 to Shire Pharmaceuticals
Group
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| pdf
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| Signature:
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| Jennie C. Butler
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| C1
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| 12/19/2005
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| 12/19/2005
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| Drug Industry
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| Barr Laboratories
Inc
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| TOC
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| Signature:
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| Christine J Siwik
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| LET1
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| 12/22/2005
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| 12/22/2005
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| Drug Industry
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| Shire Pharmaceutical
Group PLC
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| pdf
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| Signature:
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| Charles A LaPree, RAC
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| C2
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| 12/30/2005
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| 12/28/2005
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| Private Industry
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| Impax Laboratories
Inc
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| pdf
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| Signature:
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| Mark C Shaw
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| SUP1
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| 01/26/2006
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| 01/26/2006
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| Drug Industry
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| Shire Pharmaceuticals
Group
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| pdf
Exhibit A
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| Signature:
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| Eliseo O. Salinas, M.D., M.Sc.
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| C3
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| 03/10/2006
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| 03/10/2006
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| Individual Consumer
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| D. Lowe
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| LET2
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| 04/19/2006
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| 04/19/2006
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| Federal Government
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| HFD-005 to Shire Pharmaceuticals Group
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| pdf
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| Signature:
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| Jane A. Axelrad
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Top | Up
Page last updated
April 26, 2006
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