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1977N-0094L:Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
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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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| 12/19/2006
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| FDA
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| FDA
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| 12/26/2006
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| 77314-77352
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| 06/19/2007
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| pdf
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| Signature:
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| Jeffrey Shuren
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| EC1
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| 12/21/2006
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| 12/20/2006
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| Individual
Consumer
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| N/A
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| EC2
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| 12/21/2006
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| 12/20/2006
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| Health
Professional
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| Dr. Ijeoma
Eleazu
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| EMC1
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| 12/20/2006
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| 12/19/2006
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| Individual
Consumer
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| J.
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| EC3
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| 12/22/2006
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| 12/21/2006
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| Individual
Consumer
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| Mr. Arthur
Slutzah
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| NPR2
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| 12/19/2006
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| FDA
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| FDA
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| 12/26/2006
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| 77314-77352
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| Number not used
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| Signature:
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| Number not used
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| BKG1
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| 12/19/2006
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| 12/19/2006
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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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| Signature:
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| Background Material
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| EREG1
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| 05/03/2007
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| 05/02/2007
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| Health
Professional
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| R. N.-B. S. N.
Students for University of Virginia
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| pdf
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| Signature:
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| Jennifer Jamison, R. N.
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| EC4
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| 05/11/2007
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| 05/04/2007
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| Health Care
Association
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| American Assn for the
Study of Liver Diseases
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| htm
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| Signature:
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| Gores, Gregory
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| C1
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| 05/21/2007
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| 05/18/2007
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| Association
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| National Kidney
Foundation, Inc.
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| pdf
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| Signature:
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| Allan J. Collins, M.D.
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| C2
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| 05/22/2007
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| 05/22/2007
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| Other
Organization
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| American Academy of
Family Physicians
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| pdf
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| Signature:
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| Larry S. Fields, MD,
FAAFP
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| C3
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| 05/24/2007
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| 05/24/2007
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| Association
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| National Association
of Chain Drug Stores
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| pdf
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| Signature:
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| John M. Coster, Ph.D.,
R.Ph.
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| C4
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| 05/24/2007
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| 05/24/2007
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| Private
Industry
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| Bayer
HealthCare
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| pdf
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| Signature:
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| Leonard M. Baum, RPh
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| C5
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| 05/25/2007
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| 05/25/2007
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| Association
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| American Liver
Foundation
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| pdf
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| Signature:
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| James L. Boyer, M.D.
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| C6
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| 05/25/2007
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| 05/25/2007
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| Association
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| Consumer Healthcare
Products Association
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| pdf
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| Signature:
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| David C. Spangler
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| C7
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| 05/25/2007
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| 05/25/2007
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| Private
Industry
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| McNeil Consumer
Healthcare
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| Table of Contents
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| 17 Total
Volumes
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| Signature:
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| Lynn A. Pawelski
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Top | Up
Page last updated:
June 5, 2007
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