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| Document #
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| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
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|
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|
| CP1
|
| 09/19/2005
|
| 09/20/2005
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| Drug Industry
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| Savient Pharmaceuticals,
Inc.
|
|
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| pdf
|
|
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| Signature:
|
| Edward John Allera and Theodore
Su
|
|
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| ACK1
|
| 09/20/2005
|
| 09/20/2005
|
| Federal Government
|
| HFA-305 to Savient
Pharmaceuticals, Inc.
|
|
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|
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| pdf
|
|
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|
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| Signature:
|
| Lyle D. Jaffe
|
|
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| C1
|
| 10/17/2005
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| 10/17/2005
|
| Private Industry
|
| Hyman, Phelps &
McNamara, P.C.
|
|
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|
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|
|
| pdf
|
|
|
|
| Signature:
|
| Robert A. Dormer and Josephine
M. T
|
|
|
|
| CR1
|
| 10/18/2005
|
| 10/18/2005
|
| Private Industry
|
| Hyman, Phelps &
McNamara, P.C.
|
|
|
|
|
|
|
| pdf
|
| Correction to C 1
found in this docket.
|
|
| Signature:
|
| Josephine M. Torrente
|
|
|
|
|
|
| SUP1
|
| 02/02/2006
|
| 02/02/2006
|
| Drug Industry
|
| Savient Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Edward John Allera
|
|
|
| C2
|
| 02/27/2006
|
| 02/21/2006
|
| Private Industry
|
| Hyman, Phelps &
McNamara, P.C.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Robert A. Dormer and Josephine
M. T
|
|
|
| C3
|
| 03/03/2006
|
| 03/01/2006
|
| Private Industry
|
| Frommer Lawrence &
Haug, LLP
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Charles J. Raubicheck
|
|
|
| LET1
|
| 03/21/2006
|
| 03/21/2006
|
| Federal Government
|
| HFD-005 to Buchanan
Ingersoll
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Jane A. Axelrad
|
|
|
|
| RC1
|
| 04/25/2006
|
| 04/25/2006
|
| Drug Industry
|
| Savient Pharmaceuticals,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Edward John Allera
| |
|
| PDN1
|
| 12/01/2006
|
| 12/01/2006
|
| Federal Government
|
| FDA/CDER to Buchanan
Ingersoll PC on behald of Savient Pharmaceuticals Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
| Signature:
|
| Steven K Galson MD MPH
|
|
|
| PRC1
|
| 12/05/2006
|
| 12/05/2006
|
| Private Industry
|
| Savient Pharmaceuticals
Inc
|
|
|
|
|
|
|
| Table
of Contents
|
|
|
|
| Signature:
|
| Edward John Allerga, Theodore
M Su
|
|
|
| ACK2
|
| 12/05/2006
|
| 12/05/2006
|
| Federal Government
|
| FDA/DDM to Savient
Pharmaceuticals Inc
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Jennie C Butler
| |
|