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2007N-0417: Acarbose Tablets and 180-Day Exclusivity
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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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| LET1
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| 10/29/2007
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| 10/29/2007
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| Federal
Government
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| FDA/CDER/OGD
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| pdf
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| Signature:
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| Gary J. Buehler
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| LET2
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| 10/29/2007
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| 10/29/2007
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| Private
Industry
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| Upsher-Smith
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| pdf
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| Signature:
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| Sean Mahoney
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| LET3
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| 10/29/2007
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| 10/29/2007
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| Private
Industry
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| Teva North
America
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| pdf
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| Signature:
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| Marc Goshko
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| LET4
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| 10/11/2007
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| 10/11/2007
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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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| C1
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| 11/06/2007
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| 11/06/2007
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| Private
Industry
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| Roxane
Laboratories
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| pdf
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| Signature:
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| Elizabeth Ernst
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| EC1
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| 11/14/2007
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| 11/13/2007
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| Drug Industry
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| Mr. Brian
Malkin
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| Signature:
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| Malkin, Brian
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Top | Up
Page last updated:
November 15, 2007
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