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2005P-0127:
ABBREVIATED NEW DRUG APPLICATIONS(ANDA'S) REFERENCING ARAVA(LEFLUNOMIDE)
TABLETS
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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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| 03/31/2005
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| 03/31/2005
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| Drug Industry
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| Aventis Pharmaceuticals,
inc.
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| Table
of Contents
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| Signature:
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| Peter aO. Safir
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| ACK1
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| 04/04/2005
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| 04/04/2005
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| Federal Government
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| HFA-305 to Covington
and Burling
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| C1
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| 05/13/2005
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| 05/12/2005
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| Drug Industry
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| Kali Laboratories,
Inc. (Kali)
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| Table
of Contents
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| Signature:
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| W. Scott Groner
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| C2
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| 05/18/2005
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| 05/18/2005
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| Private Industry
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| Olsson, Frank and
Weeda, P.C.
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| pdf
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| Signature:
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| Arthur Y. Tsien
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| RC1
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| 06/10/2005
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| 06/10/2005
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| Private Industry
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| Aventis Pharmaceuticals
Inc
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| Table
of Contents
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| Signature:
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| Peter O Safir
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| PDN1
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| 09/16/2005
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| 09/16/2005
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| Federal Government
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| HFD-1 to Covington
& Burling
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| pdf
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| Signature:
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| Steven K Galson MD MPH
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Top
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Page last updated
October 4, 2005
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