2007N-0389: Granisetron Hydrochloride Injection and 180-day Generic Drug 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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| 10/11/2007
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| 10/11/2007
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| Private Industry
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| Teva Parenteral Medicines,
Inc.
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| pdf
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| Signature:
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| Marc Goshko
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| LET2
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| 10/16/2007
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| 10/16/2007
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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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| C1
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| 10/25/2007
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| 10/25/2007
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| Private Industry
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| WINSTON & STRAWN
LLP
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| pdf
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| Signature:
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| James F. Hurst
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| EC1
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| 10/31/2007
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| 10/25/2007
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| Drug Industry
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| Baxter Healthcare
Corporation
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| pdf
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| Signature:
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| Polen, Tom
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| C2
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| 10/31/2007
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| 10/31/2007
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| Private Industry
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| A. Tsien
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| C3
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| 11/01/2007
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| 11/01/2007
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| Individual Consumer
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| D. G. Adams
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| LET3
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| 1/23/2008
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| 1/23/2008
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| Federal Government
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| D. G. Adams
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| pdf
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| Signature:
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| Gary J. Buehler
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Top | Up
Page last updated:
January 23, 2008
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