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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
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
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|
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|
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| CP1
|
| 02/13/2004
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| 02/13/2004
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| Drug Industry
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| Rotta Pharmaceuticals
Inc
|
|
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|
|
|
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| pdf,
Orig.
Submission, Attachments: pdf02,pdf04
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|
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| Signature:
|
| Martin J Hahn
|
|
|
| LET1
|
| 02/13/2004
|
| 02/13/2004
|
| Federal
Government
|
| HFS-255 to Hogan &
Hartson LLP
|
|
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|
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| pdf
|
|
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| Signature:
|
| Paulette M Gaynor PhD
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| LET2
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| 02/13/2004
|
| 02/13/2004
|
| Drug Industry
|
| Rotta Pharmaceuticals
Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Martin J Hahn
|
|
|
| LET3
|
| 02/13/2004
|
| 02/13/2004
|
| Drug Industry
|
| Rotta Pharmaceuticals
Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Martin J Hahn
|
|
|
| LET4
|
| 02/13/2004
|
| 02/13/2004
|
| Drug Industry
|
| Rotta Pharmaceuticals
Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Martin J Hahn
|
|
| LET5
|
| 02/13/2004
|
| 02/13/2004
|
| Drug Industry
|
| Rotta Pharmaceuticals
Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Martin J Hahn
|
|
|
| LET6
|
| 02/13/2004
|
| 02/13/2004
|
| Federal
Government
|
| HFS-200 to Hogan &
Hartson LLP
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Laura Tarantino PhD
|
|
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| MT1
|
| 05/25/2004
|
| 05/25/2004
|
| Federal
Government
|
| FDA and
Hogan and Hartson on behalf of Rotta Pharmaceuticals
|
|
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|
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|
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|
|
|
| Signature:
|
| Kathy Ellwood PhD
|
|
|
| LET7
|
| 05/25/2004
|
| 05/25/2004
|
| Private Industry
|
| Rotta Pharamceuticals
Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Martin J Hahn
|
|
|
| EMC1
|
| 05/29/2004
|
| 05/29/2004
|
| Drug Industry
|
| Nutramax Laboratories,
Inc.
|
|
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|
|
| doc,
pdf
|
|
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|
| Signature:
|
| Kristen E. Blanchard
|
|
|
| SUP1
|
| 06/03/2004
|
| 06/03/2004
|
| Drug Industry
|
| Weider Nutrition International,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Jonathan W. Emord
|
|
|
| SUP2
|
| 06/25/2004
|
| 06/24/2004
|
| Dietary
Supplement Industry
|
| Weider Nutrition International,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Jonathan W. Emord
|
|
|
| EXT1
|
| 08/23/2004
|
| 08/23/2004
|
| Drug Industry
|
| Rotta Pharmaceuticals,
Inc. (Rotta)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Martin J. Hahn
|
|
| LET8
|
| 08/23/2004
|
| 08/23/2004
|
| Federal
Government
|
| HFS-830
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Julie Schrimpf
|
|
|
| LET9
|
| 09/17/2004
|
| 09/17/2004
|
| Drug Industry
|
| Rotta Pharmaceuticals
Inc. (Rotta)
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Martin J. Hahn
|
|
|
| LET10
|
| 09/17/2004
|
| 09/17/2004
|
| Drug Industry
|
| Rotta Pharmaceuticals
Inc. (Rotta)
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Martin J. Hahn
|
|
|
| PDN1
|
| 10/12/2004
|
| 10/12/2004
|
| Federal
Government
|
| HF-22 to
Hogan & Hartson LLP on behalf of Rotta Pharmaceuticals,
Inc
|
|
|
|
|
|
|
| pdf,
Fotnotes: Tab3-13,
Tab3-14
|
|
|
|
|
|
|
|
| Signature:
|
| William K Hubbard
| |
|
| LET11
|
| 01/03/2005
|
| 01/03/2005
|
| Drug Industry
|
| Rotta Pharmaceuticals
Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Martin J Hahn
|
|
|
| LET12
|
| 02/10/2005
|
| 02/10/2005
|
| Federal
Government
|
| HFS-800 to Hogan &
Hartson, LLP
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Barbara O. Schneeman, PhD
|
|
| |