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2006P-0410:
Refuse to Approve any ANDA for Amifostine Product with Labeling
which Omits Dosage and Other 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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CP1 |
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10/10/2006
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10/10/2006
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Private Industry
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MedImmune Oncology,
Inc. |
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pdf
Attachments |
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Signature: |
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William C. Bertrand, Jr.
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ACK1 |
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10/10/2006
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10/10/2006
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Federal Government |
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FDA/DDM to MedImmune
Oncology, Inc. |
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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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| 10/26/2006
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| 10/26/2006
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| Individual Consumer
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| D. Lowe
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| C2
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| 12/21/2006
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| 12/21/2006
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| Drug Industry
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| Sun Pharmaceutical
Industries, Ltd.
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| Table
of Contents
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| Signature:
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| James F. Hurst
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| EC1
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| 12/29/2006
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| 12/28/2006
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| Drug Industry
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| MedImmune
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| pdf
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| Signature:
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| Bertrand, William
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| C3
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| 01/31/2007
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| 01/31/2007
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| Drug Industry
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| MedImmune Oncology,
Inc. (MedImmune)
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| pdf
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| Signature:
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| William C. Bertrand, Jr.
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| C4
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| 02/27/2007
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| 02/27/2007
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| Private Industry
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| Sun Pharmaceutical
Industries, Ltd.
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| pdf
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| Signature:
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| James F. Hurst
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| C5
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| 03/29/2007
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| 03/29/2007
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| Drug Industry
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| Sun Pharmaceutical
Industries Ltd
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| pdf
Attachment
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| Signature:
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| James F Hurst
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| LET1
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| 04/05/2007
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| 04/05/2007
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| Federal Government
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| FDA/CDER to MedImmune
Oncology Inc
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| pdf
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| Signature:
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| Jane A Axelrad
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| RC1
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| 04/12/2007
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| 04/12/2007
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| Private Industry
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| MedImmune Oncology
Inc
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| pdf
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| Signature:
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| William C Betrand Jr
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Top | Up Page last updated:
April 17, 2007
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