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| Dockets Entered
On August 2, 2006
Table of Contents
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| Docket #
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| Title
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006N-0187
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women
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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2006N-0215
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-mon
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| 2006P-0086
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| To declare that the drug product, Butalbital, 50 mg and acetaminophen, 300 mg Tablets, is suitable for consideration in an abbreviated new drug application (ANDA).
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| 2006P-0271
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| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
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| 2006P-0290
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| Risk Management Program for Fentanyl Products
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| 2006P-0305
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| Permit the Filing of an ANDA Suitability for Loperamide Hydrochloride Orally Dissolving Strips, 2 mg
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| 2006V-0304
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| Laser Light Show
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7531
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| J. Kahl
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| Vol #:
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| 339
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| C 7532
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| D. Schulte
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| Vol #:
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| 339
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| C 7533
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| B. Blitz
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| Vol #:
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| 339
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| EC 28
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| Mr. Dave Lowe
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| Vol #:
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| 5
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| EC 29
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| Mrs. Kelley Smith
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| Vol #:
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| 5
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| EC 14
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| EC 15
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| REMA SP. Z O.O.
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 17977
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| J. Bailey
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| Vol #:
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| 194
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| C 17978
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| F. Henson
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| Vol #:
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| 194
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| C 17979
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| M. Galante
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| Vol #:
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| 194
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| C 17980
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| J. Backenstow
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| Vol #:
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| 194
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| C 17981
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| L. Flavell
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| Vol #:
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| 194
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| C 17982
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| D. Montano
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| Vol #:
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| 194
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| C 17983
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| C. Beaird
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| Vol #:
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| 194
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| C 17984
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| Y. Mavros
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| Vol #:
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| 194
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| C 17985
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| S. Goguen
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| Vol #:
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| 194
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| C 17986
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| J. Hofmann
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| Vol #:
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| 194
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| C 17987
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| J. Langermeui
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| Vol #:
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| 194
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| C 17988
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| I. Csali
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| Vol #:
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| 194
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| C 17989
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| J. Langermeui
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| Vol #:
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| 194
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| EC 6
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| Alcon Laboratories
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| Vol #:
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| 1
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| EC 7
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| Harbor-UCLA Medical Center
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| Vol #:
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| 1
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| EC 5
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| Family Research Council
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| Vol #:
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| 1
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| 2006N-0187
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women
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| EC 1
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| International Formula Council
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| Vol #:
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| 1
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| EC 2
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| Ms. Marsha Walker
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| Vol #:
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| 1
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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| C 1
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| American Free Trade Association
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| Vol #:
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| 1
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| EC 3
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| Canadian Food Inspection Agency
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| Vol #:
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| 1
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| EC 4
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| Express Delivery
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| Vol #:
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| 1
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| EC 5
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| American Free Trade Association (AFTA)
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| Vol #:
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| 1
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| EC 6
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| Fedex Express
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| Vol #:
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| 1
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| 2006N-0215
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-mon
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| EC 1
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| Pharmaceutical Research and Manufacturers of Ameri
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| Vol #:
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| 1
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| 2006P-0086
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| To declare that the drug product, Butalbital, 50 mg and acetaminophen, 300 mg Tablets, is suitable for consideration in an abbreviated new drug application (ANDA).
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| EC 675
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| Ms. C K
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| Vol #:
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| 3
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| EC 676
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| Mrs. Karen Banichar
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| Vol #:
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| 3
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| EC 677
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| Mrs. Michaela Donohue
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| Vol #:
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| 3
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| EC 678
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| Ms. Jill Sarcia
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| Vol #:
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| 3
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| EC 679
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| University of Ottawa
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| Vol #:
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| 3
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| EC 680
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| Ms. H. Evon Peterson
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| Vol #:
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| 3
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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|
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| EC 13
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 14
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| Mr. D Lowe
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| Vol #:
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| 1
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| EC 10
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 11
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0271
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| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
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| C 1
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| Society of Infectious Diseases Pharmacists
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| Vol #:
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| 2
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| 2006P-0290
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| Risk Management Program for Fentanyl Products
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0305
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| Permit the Filing of an ANDA Suitability for Loperamide Hydrochloride Orally Dissolving Strips, 2 mg
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| ACK 1
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| FDA/ DDM to Monosol Rx, LLC.
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| Vol #:
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| 1
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| CP 1
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| Monosol Rx, LLC.
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| Vol #:
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| 1
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| 2006V-0304
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| Laser Light Show
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| ACK 1
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| FDA/ DDM to Hart Entertainment
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| Vol #:
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| 1
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| VAR 1
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| Hart Entertainment
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| Vol #:
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| 1
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