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2007N-0262:
Ramipril Capsules 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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| NPR1
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| 09/17/2007
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| FDA
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| FDA
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| 09/20/2007
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| 53711-53733
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| 11/19/2007
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| pdf
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| Signature:
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| Jeffrey Shuren
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| BKG1
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| 09/17/2007
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| 09/19/2007
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| Federal Government
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| Background Material
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| Table
of Contents
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| 6 Total Volumes
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| FONS1
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| 09/17/2007
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| 09/19/2007
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| Federal Government
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| FONSI
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| pdf
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| EA1
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| 09/17/2007
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| 09/19/2007
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| Federal Government
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| ENVIRONMENTAL ASSESSMENT
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| pdf
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| REF1
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| 09/20/2007
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| 09/20/2007
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| Federal Government
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| Federal Government
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| Table
of Contents
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| Signature:
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| Diane Sullivan
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| EREG1
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| 09/24/2007
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| 09/20/2007
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| Individual Consumer
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| b. sachau
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| EC1
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| 10/11/2007
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| 10/07/2007
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| Individual Consumer
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| Mr. Fred Christoffer
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| EC2
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| 10/11/2007
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| 10/07/2007
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| Individual Consumer
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| Mr. Thomas Kling
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| EC3
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| 10/12/2007
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| 10/11/2007
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| Individual Consumer
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| Mrs. Joan O'Keefe
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| EC4
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| 10/15/2007
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| 10/13/2007
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| Individual Consumer
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| Mrs. Angie Cornelius
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| C1
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| 10/16/2007
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| 10/16/2007
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| Individual Consumer
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| Unknown
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| C2
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| 10/17/2007
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| 10/17/2007
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| Individual Consumer
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| L. Delaney
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| C3
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| 10/24/2007
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| 10/23/2007
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| Health Professional
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| The American Association
for Respiratory Care (AARC)
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| pdf
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| Signature:
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| Toni Rodriguez
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| EC5
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| 10/26/2007
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| 10/24/2007
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| Health Professional
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| RRT-NPS
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| Signature:
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| HICKMAN, ARLAIN
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| EC6
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| 10/31/2007
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| 10/27/2007
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| Individual Consumer
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| Mr. Kie Watkins
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| C4
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| 10/30/2007
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| 10/30/2007
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| Private Industry
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| American Association
for Respiratory Care
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| pdf
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| Signature:
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| Toni Rodriguez
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| EC7
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| 11/06/2007
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| 11/05/2007
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| Consumer Group
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| Mr. David Lott
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| NEC1
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| 11/07/2007
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| FDA
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| FDA
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| 11/08/2007
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| 63141-63143
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| 12/19/2007
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| pdf
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| COMMENTS DUE 12/19/2007
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| Signature:
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| JEFFREY SHUREN
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| C5
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| 11/13/2007
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| 11/13/2007
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| Individual Consumer
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| Jeralyn Delaney
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| C6
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| 11/15/2007
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| 11/15/2007
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| Individual Consumer
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| John Delaney
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| EC8
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| 11/20/2007
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| 11/19/2007
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| Individual Consumer
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| Ms. S T
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| EC9
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| 11/20/2007
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| 11/19/2007
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| Individual Consumer
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| asthma patients
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| C7
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| 11/23/2007
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| 11/23/2007
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| Individual Consumer
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| Susan Tumbarello
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| EC10
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| 11/28/2007
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| 11/21/2007
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| Drug Industry
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| Mr. Robert Sussman
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| C8
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| 12/05/2007
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| 12/05/2007
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| Private Industry
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| Wyeth Consumer Healthcare
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| pdf
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| Signature:
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| Lauren Quinn
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| EC11
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| 12/06/2007
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| 12/04/2007
|
| Private Industry
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| International Pharmaceutical
Aerosol Consortium
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| htm
|
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| Signature:
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| Hardwick, Maureen
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|
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| EC12
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| 12/11/2007
|
| 12/10/2007
|
| Health Professional
|
| Mr. Terry Franzel
RN, BSN
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| C9
|
| 12/17/2007
|
| 12/17/2007
|
| Individual Consumer
|
| D. Warren
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Top
| Up
Page last updated:
December 18, 2007
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