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2005P-0048:
PROFESSIONAL LABELING FOR ASPIRIN DOSING IN ORDER TO SPECIFY THE
MOREFAVORABLE BENEFIT/RISK PROFILE OF ASPIRIN DOSES OF 75-150 MG/DAY
FOR SECONDARY CARDIOVASCULAR PREVENTION, 5-=150 MG/DAY FOR SECONDARY
CEREBROVASCULAR PREVENTION
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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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| 02/01/2005
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| 02/01/2005
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| Private Industry
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| McNeil Consumer &
Specialty Pharmaceuticals
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| TOC
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| Signature:
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| William L. McComb
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| ACK1
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| 02/01/2005
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| 02/01/2005
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| Federal
Government
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| HFA-305
to McNeil Consumer & Specialty Pharmaceuticals
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| pdf
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| Signature:
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| Jennie C. Butler
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| C1
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| 05/04/2005
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| 05/03/2005
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| Academia
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| American College of
GAstroenterology
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| pdf
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| Signature:
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| Jay Popp, Jr., M.D., FACG
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| C2
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| 05/05/2005
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| 05/04/2005
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| Drug Industry
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| Bayer HealthCare Consumer
Care Division
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| TOC
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| Signature:
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| Leonard Baum RPh
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| C3
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| 05/24/2005
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| 05/24/2005
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| Association
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| National Stroke Association
(NSA)
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| pdf
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| Signature:
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| Jim Baranski
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| LET1
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| 07/28/2005
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| 07/28/2005
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| Federal
Government
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| HFD-1 to
McNeil Consumer & Specialty Pharmaceuticals
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| pdf
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| Signature:
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| Steven Galson MD
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| SUP1
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| 08/05/2005
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| 08/03/2005
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| Drug Industry
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| McNeil Consumer &
Specialty Pharmaceuticals
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| Table
of Contents
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| Signature:
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| Minne Baylor-Henry, JD
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| C4
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| 09/16/2005
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| 09/15/2005
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| Private Industry
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| Bayer HealthCare,
Consumer Care Division
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| pdf
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| Signature:
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| Leonard Baum RPh
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| C5
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| 10/18/2005
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| 10/13/2005
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| Association
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| American Heart Association
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| pdf
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| Signature:
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| Robert H. Eckel, MD, FAHA
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| C6
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| 12/06/2005
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| 12/05/2005
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| Association
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| National Stroke Association
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| pdf
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| Signature:
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| James Baranski
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| C7
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| 12/13/2005
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| 12/10/2005
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| Association
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| Preventive
Cardiovascular Nurses Association (PCNA)
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| pdf
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| Signature:
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| Suzanne Hughes, MSN, RN
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Top | Up
Page last updated
December 29, 2005
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