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| Dockets Entered
On March 27, 2007
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| 2003E-0252
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| Patent Extension for A180 (danofloxacin mesylate), 4,861,779
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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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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| 2006P-0392
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| Refrain from approving any ANDA for a Diazepam Rectal Gel that Relies on Diastat
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0398
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| Require bioequivalence studies for generic or follow-on formulations of MEGACE ES (megestrol acetate oral suspension 625 mg/5 ml)
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| 2007M-0107
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| P980022/S015 - Guardian REAL-Time and Paradigm REAL-Time Systems
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| 2007M-0108
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| P060019 - Therapy Cool Path Ablation Catheter and IBI 1500T9 RF Ablation Generator
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| 2007M-0109
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| P040051 - Stelkast Surpass Acetabular System
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| 2007N-0061
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| Sipuleucel-T Dendreon
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| 2007N-0090
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| Zimulti Endocrinologic and Metabolic Drugs Advisory Committee Meeting, June 13, 2007
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| 2007N-0098
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
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| 2007P-0074
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| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0116
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| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
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| 2007P-0119
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| to permit an ANDA Suitability for Hydrocodone Bitartrate and Homatropine Methylbromide Syrup
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 19675
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| Hillestad Pharmaceuticals
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| Vol #:
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| 174
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| LET 19676
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| NBTY Inc.
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| Vol #:
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| 174
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| LET 19677
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| Scandinavian Clinical Nutrition, Stockolm, Sweden.
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| Vol #:
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| 174
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| LET 19678
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| Hillestad Pharmaceuticals USA, Inc.
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| Vol #:
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| 174
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| LET 19679
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| Biotech Corporation, Inc.
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| Vol #:
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| 174
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| LET 19680
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| Biotech Corporation, Inc.
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| Vol #:
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| 174
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| LET 19681
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| LET 19682
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| |
|
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| LET 19683
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 174
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| |
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| LET 19684
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| National Enzyme Company
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| Vol #:
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| 174
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| |
|
|
| LET 19685
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| National Enzyme Company
|
| Vol #:
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| 174
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| |
|
|
| LET 19686
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 174
|
|
| | | | | | | | |
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| |
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| LET 19687
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 174
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| |
|
|
| LET 19688
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19689
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 174
|
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|
|
| LET 19690
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| The Daily Wellness Company
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| Vol #:
|
| 174
|
| |
|
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| LET 19691
|
| Weight Loss Innovations, LP
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19692
|
| NBTY Inc.
|
| Vol #:
|
| 174
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| |
|
|
| LET 19693
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19694
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19695
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19696
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19697
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19698
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19699
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19700
|
| NBTY Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19701
|
| Supple Beverages, LLC
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19702
|
| Weight Loss Innovations, LP
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19703
|
| Nutramax Laboratories, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19704
|
| New Century Company
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19705
|
| Organic India U.S.A.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19706
|
| NeuroScience
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19707
|
| Iovate Health Sciences U.S.A. Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19708
|
| Iovate Health Sciences U.S.A. Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19709
|
| Iovate Health Sciences U.S.A. Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19710
|
| Iovate Health Sciences U.S.A. Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19711
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| Iovate Health Sciences U.S.A. Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19712
|
| Iovate Health Sciences U.S.A. Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19713
|
| Vitamin Shoppe Industries Inc.
|
| Vol #:
|
| 174
|
|
| |
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
| |
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|
| C 12866
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| M. Warnke & B. Subers
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| Vol #:
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| 807
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| |
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| C 12867
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| M. Craig
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| Vol #:
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| 807
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| C 12868
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| B. Balistreri
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| Vol #:
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| 807
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| C 12869
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| M. Kelley
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| Vol #:
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| 807
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| C 12870
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| K. Zanger
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| Vol #:
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| 807
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| C 12871
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| C. Newcombe
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| Vol #:
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| 807
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| C 12872
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| M. Wyenn
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| Vol #:
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| 807
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| C 12873
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| P. Thompson
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| Vol #:
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| 807
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| C 12874
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| L. Marks
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| Vol #:
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| 807
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| C 12875
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| A. Blum
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| Vol #:
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| 807
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| C 12876
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| N. Smith
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| Vol #:
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| 807
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| C 12877
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| J. Bevilacqua
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| Vol #:
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| 807
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| C 12878
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| T. Olechiw
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| Vol #:
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| 807
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| C 12879
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| D. Dawe
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| Vol #:
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| 807
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| C 12880
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| C. Calabrese
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| Vol #:
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| 807
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| C 12881
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| M. Lunde
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| Vol #:
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| 807
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| C 12882
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| R. Pasichnyk
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| Vol #:
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| 807
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| C 12883
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| W. Fraize
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| Vol #:
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| 807
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| C 12884
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| L. Valentine
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| Vol #:
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| 807
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| C 12885
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| M. Shah
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| Vol #:
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| 807
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| C 12886
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| D. Wolski
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| Vol #:
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| 807
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| C 12887
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| K. Becker
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| Vol #:
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| 807
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| C 12888
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| R. Beveridge
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| Vol #:
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| 807
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| C 12889
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| M. Mendoza
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| Vol #:
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| 807
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| |
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| C 12890
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| R. Humphrey
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| Vol #:
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| 807
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| C 12891
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| K. Kinsella
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| Vol #:
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| 807
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| C 12892
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| W. Stansell
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| Vol #:
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| 807
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| C 12893
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| D. Caruso
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| Vol #:
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| 807
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| C 12894
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| M. Crandall
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| Vol #:
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| 807
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| |
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| C 12895
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| N. Smith
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| Vol #:
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| 807
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| C 12896
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| T. Palin
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| Vol #:
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| 807
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| |
|
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| C 12897
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| K. Albright
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| Vol #:
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| 807
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| |
|
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| C 12898
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| L. Drews
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| Vol #:
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| 807
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| |
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| C 12899
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| T. Bristol
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| Vol #:
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| 807
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| C 12900
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| K. Leno
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| Vol #:
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| 807
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| |
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| C 12901
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| B. Dreisbach
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| Vol #:
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| 807
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| |
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| C 12902
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| R. Hartman
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| Vol #:
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| 807
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| |
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| C 12903
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| M. Kalicin
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| Vol #:
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| 807
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| |
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| C 12904
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| R. Kwan
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| Vol #:
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| 807
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| |
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| C 12905
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| D. Curry
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| Vol #:
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| 807
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| |
|
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| C 12906
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| C. Amundson
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| Vol #:
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| 807
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| |
|
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| C 12907
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| A. Raymond
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| Vol #:
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| 807
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| |
|
|
| C 12908
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| S. Bosse
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| Vol #:
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| 807
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| |
|
|
| C 12909
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| P. Pinto
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| Vol #:
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| 807
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| |
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|
| C 12910
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| L. White
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| Vol #:
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| 807
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| | | | | | | |
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| |
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| C 12911
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| L. White
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| Vol #:
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| 807
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| |
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| C 12912
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| L. White
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| Vol #:
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| 807
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| C 12913
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| K. Van Dame
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| Vol #:
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| 807
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| |
|
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| C 12914
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| K. Van Dame
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| Vol #:
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| 807
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| |
|
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| C 12915
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| C. Berry
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| Vol #:
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| 807
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| |
|
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| C 12916
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| M. Hoodwin
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| Vol #:
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| 807
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| |
|
|
| C 12917
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| J. Guest
|
| Vol #:
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| 807
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| |
|
|
| C 12918
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| F. Brongil
|
| Vol #:
|
| 807
|
| |
|
|
| C 12919
|
| Global Issues
|
| Vol #:
|
| 807
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| |
|
|
| C 12920
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| F.
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| Vol #:
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| 807
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| |
|
|
| C 12921
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| Z. Blum
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| Vol #:
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| 807
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| |
|
|
| C 12922
|
| Pesticide Action Network of North America
|
| Vol #:
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| 807
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| |
|
|
| C 12923
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| E. Hockert
|
| Vol #:
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| 807
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| |
|
|
| C 12924
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| N. Davidson
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| Vol #:
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| 807
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| |
|
|
| C 12925
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| F. Morrison
|
| Vol #:
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| 807
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| |
|
|
| C 12926
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| J. Adler
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| Vol #:
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| 807
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| |
|
|
| C 12927
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| L. Warren
|
| Vol #:
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| 807
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| |
|
|
| C 12928
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| P. & N. Adix
|
| Vol #:
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| 807
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| |
|
|
| C 12929
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| M. Kroh
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| Vol #:
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| 807
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| |
|
|
| C 12930
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| D. Noskey
|
| Vol #:
|
| 807
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| |
|
|
| C 12931
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| P. Malek
|
| Vol #:
|
| 807
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| |
|
|
| C 12932
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| M. Bingham
|
| Vol #:
|
| 807
|
| |
|
|
| C 12933
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| R. Cruz
|
| Vol #:
|
| 807
|
| |
|
|
| C 12934
|
| B. Freed
|
| Vol #:
|
| 807
|
| |
|
|
| C 12935
|
| J. Sowalsky
|
| Vol #:
|
| 807
|
| |
|
|
| C 12936
|
| B. Young
|
| Vol #:
|
| 807
|
| |
|
|
| C 12937
|
| M. Hansen
|
| Vol #:
|
| 807
|
| |
|
|
| C 12938
|
| J. Hahn
|
| Vol #:
|
| 807
|
| |
|
|
| C 12939
|
| S. Warner
|
| Vol #:
|
| 807
|
| |
|
|
| C 12940
|
| M. Matthewmen
|
| Vol #:
|
| 807
|
| |
|
|
| C 12941
|
| J. Arcy
|
| Vol #:
|
| 807
|
| |
|
|
| C 12942
|
| S. Davidner
|
| Vol #:
|
| 807
|
| |
|
|
| C 12943
|
| E. Tucholke
|
| Vol #:
|
| 807
|
| |
|
|
| C 12944
|
| B. Krich
|
| Vol #:
|
| 807
|
| |
|
|
| C 12945
|
| G. Castanna
|
| Vol #:
|
| 807
|
| |
|
|
| C 12946
|
| D. Potter
|
| Vol #:
|
| 807
|
| |
|
|
| C 12947
|
| T. Solari
|
| Vol #:
|
| 807
|
|
| | | | | | | |
|
| |
|
| C 12948
|
| M. McMahon-Thoms
|
| Vol #:
|
| 807
|
| |
|
|
| C 12949
|
| J. Allen
|
| Vol #:
|
| 807
|
| |
|
|
| C 12950
|
| E. McGregor
|
| Vol #:
|
| 807
|
| |
|
|
| C 12951
|
| C. Hoven
|
| Vol #:
|
| 807
|
| |
|
|
| C 12952
|
| G. Porter
|
| Vol #:
|
| 807
|
| |
|
|
| C 12953
|
| S. Playtis
|
| Vol #:
|
| 807
|
| |
|
|
| C 12954
|
| T. Stromme
|
| Vol #:
|
| 807
|
| |
|
|
| C 12955
|
| S. McClelland
|
| Vol #:
|
| 807
|
| |
|
|
| C 12956
|
| K. Bauknight
|
| Vol #:
|
| 807
|
| |
|
|
| C 12957
|
| H. Luksan
|
| Vol #:
|
| 807
|
| |
|
|
| C 12958
|
| R. Lenihan
|
| Vol #:
|
| 807
|
| |
|
|
| C 12959
|
| J. Carroll
|
| Vol #:
|
| 807
|
| |
|
|
| C 12960
|
| J. DeGraff
|
| Vol #:
|
| 807
|
| |
|
|
| C 12961
|
| J. Fanger
|
| Vol #:
|
| 807
|
| |
|
|
| C 12962
|
| M. West
|
| Vol #:
|
| 807
|
| |
|
|
| C 12963
|
| M. Barrer
|
| Vol #:
|
| 807
|
| |
|
|
| C 12964
|
| D. Pedwell
|
| Vol #:
|
| 807
|
| |
|
|
| C 12965
|
| J. & S. Cody
|
| Vol #:
|
| 807
|
| |
|
|
| C 12966
|
| N. Zimmerman
|
| Vol #:
|
| 807
|
| |
|
|
| C 12967
|
| A. Pedwell
|
| Vol #:
|
| 807
|
| |
|
|
| C 12968
|
| J. & J. Pedwell
|
| Vol #:
|
| 807
|
| |
|
|
| C 12969
|
| E. Goss
|
| Vol #:
|
| 807
|
| |
|
|
| C 12970
|
| F. Brongil
|
| Vol #:
|
| 807
|
| |
|
|
| C 12971
|
| R. Reynolds
|
| Vol #:
|
| 807
|
| |
|
|
| C 12972
|
| T. Amen
|
| Vol #:
|
| 807
|
| |
|
|
| C 12973
|
| V. Weiss
|
| Vol #:
|
| 807
|
| |
|
|
| C 12974
|
| J. Bandersen
|
| Vol #:
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| L. Lane
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| 807
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| S. Inman
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| C 12995
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| B. Inman
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| A. & J. Brooks
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| C 24
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| Cornell University-New York Presbyterian Hospital-Joan and Sanford I. Weill Medical College
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| Vol #:
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| 2
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| |
|
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| 2003E-0252
|
| Patent Extension for A180 (danofloxacin mesylate), 4,861,779
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| |
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| N 1
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| FDA
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| Vol #:
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| 1
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| |
|
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| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| C 118
|
| Association of Fish and Wildlife Agencies
|
| Vol #:
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| 15
|
| |
|
|
| EC 492
|
| The Humane Society of the United States
|
| Vol #:
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| 12
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
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| C 446
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| R. Wawraez
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| Vol #:
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| 41
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| |
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| C 447
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| A. Kuck
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| Vol #:
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| 41
|
| |
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| C 448
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| A. Ochoa
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| Vol #:
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| 41
|
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| N. Allen
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| 41
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| |
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| C 450
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| P. Zanotelli
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| Vol #:
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| 41
|
| |
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| C 451
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| J. Delfs
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| Vol #:
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| 41
|
| |
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| C 452
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| E. Scott
|
| Vol #:
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| 41
|
| |
|
|
| C 453
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| D. Carey
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| Vol #:
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| 41
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| C 454
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| L. Snodgrass
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| 41
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| C 455
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| J. Hutchinson
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| Vol #:
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| 41
|
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| C 456
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| K.J.
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| Vol #:
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| 41
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| C 457
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| K. Fizdale
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| Vol #:
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| 41
|
| |
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| C 458
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| J. Stewart
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| Vol #:
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| 41
|
|
| | | | | | | |
|
| |
|
| C 459
|
| Form Letter 5
|
| Vol #:
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| 42
|
| |
|
|
| EC 3893
|
| Mrs. Jennifer Waters
|
| Vol #:
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| 22
|
| |
|
|
| EC 3894
|
| Ms. Christina Babst
|
| Vol #:
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| 22
|
| |
|
|
| EC 3895
|
| Dr. Martin Smith
|
| Vol #:
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| 22
|
| |
|
|
| EC 3896
|
| Ms. Rayann Moody
|
| Vol #:
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| 22
|
| |
|
|
| EC 3897
|
| Ms. Nancy Cumberland
|
| Vol #:
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| 22
|
| |
|
|
| EC 3898
|
| Miss. Lauren Suter
|
| Vol #:
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| 22
|
| |
|
|
| EC 3899
|
| Ms. Melanie Blackburn
|
| Vol #:
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| 22
|
| |
|
|
| EC 3900
|
| Mrs. Teresa Whitcomb
|
| Vol #:
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| 22
|
| |
|
|
| EC 3901
|
| Mrs. NANCY WALKER
|
| Vol #:
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| 22
|
| |
|
|
| EC 3902
|
| Ms. Caithlin O'Brien
|
| Vol #:
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| 22
|
| |
|
|
| EC 3903
|
| Ms. Martha Johnson
|
| Vol #:
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| 22
|
| |
|
|
| EC 3904
|
| Mrs. Marjorie Hass
|
| Vol #:
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| 22
|
| |
|
|
| EC 3905
|
| Ms. Bridget Conroy
|
| Vol #:
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| 22
|
| |
|
|
| EC 3906
|
| Mrs. Tessica Bryan
|
| Vol #:
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| 22
|
| |
|
|
| EC 3907
|
| AAVS
|
| Vol #:
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| 22
|
| |
|
|
| EC 3908
|
| National Coalition of Organized Women
|
| Vol #:
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| 22
|
| |
|
|
| EC 3909
|
| Miss. Jessica Campbell
|
| Vol #:
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| 22
|
| |
|
|
| EC 3910
|
| Ms. L. Yaco
|
| Vol #:
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| 22
|
| |
|
|
| EC 3911
|
| Mrs. Patricia Reinbold
|
| Vol #:
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| 22
|
| |
|
|
| EC 3912
|
| Ms. Janice Higgins
|
| Vol #:
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| 22
|
| |
|
|
| EC 3913
|
| Mr. Mark Lee
|
| Vol #:
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| 22
|
| |
|
|
| EC 3914
|
| Miss. Chelsea Maggs
|
| Vol #:
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| 22
|
| |
|
|
| EC 3915
|
| Miss. Brittany Smith
|
| Vol #:
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| 22
|
| |
|
|
| EC 3916
|
| Ms. Barbara Menkes
|
| Vol #:
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| 22
|
| |
|
|
| EC 3917
|
| Mrs. Stephanie Lewis
|
| Vol #:
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| 22
|
| |
|
|
| EC 3918
|
| Mr. Christopher Gonzalez
|
| Vol #:
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| 22
|
| |
|
|
| EC 3919
|
| Mrs. Jennifer Gonzalez
|
| Vol #:
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| 22
|
| |
|
|
| EC 3920
|
| Mr. Zachary Jones
|
| Vol #:
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| 22
|
| |
|
|
| EC 3921
|
| self-employed
|
| Vol #:
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| 22
|
| |
|
|
| EC 3922
|
| Ms. Ann Hawkins
|
| Vol #:
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| 22
|
| |
|
|
| EC 3923
|
| Ms. Julie Hoffheins
|
| Vol #:
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| 22
|
| |
|
|
| EC 3924
|
| Miss. Sandra Brito
|
| Vol #:
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| 22
|
| |
|
|
| EC 3925
|
| Mrs. Claudia Batiuk
|
| Vol #:
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| 22
|
| |
|
|
| EC 3926
|
| Ms. Ellen McConnell
|
| Vol #:
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| 22
|
| |
|
|
| EC 3927
|
| Mrs. Margaret Sawyer
|
| Vol #:
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| 22
|
| |
|
|
| EC 3928
|
| Mrs. Kathie Zettervall
|
| Vol #:
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| 22
|
|
| | | | | | | |
|
| |
|
| EC 3929
|
| Ms. Janelle Villafane
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3930
|
| Mrs. judy desreuisseau
|
| Vol #:
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| 22
|
| |
|
|
| EC 3931
|
| Mrs. michelle sasscer
|
| Vol #:
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| 22
|
| |
|
|
| EC 3932
|
| Miss. Crystal Ricker
|
| Vol #:
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| 22
|
| |
|
|
| EC 3933
|
| Mrs. Victoria Lerner
|
| Vol #:
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| 22
|
| |
|
|
| EC 3934
|
| Ms. Joanna Kelly
|
| Vol #:
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| 22
|
| |
|
|
| EC 3935
|
| Ms. Susan Jacobs
|
| Vol #:
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| 22
|
| |
|
|
| EC 3936
|
| Mrs. lynn van kaam
|
| Vol #:
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| 22
|
| |
|
|
| EC 3937
|
| Ms. Eleanor Cossa
|
| Vol #:
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| 22
|
| |
|
|
| EC 3938
|
| my home
|
| Vol #:
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| 22
|
| |
|
|
| EC 3939
|
| Mrs. Kendra Knight
|
| Vol #:
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| 22
|
| |
|
|
| EC 3940
|
| Ms. LISA ANDERSON
|
| Vol #:
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| 22
|
| |
|
|
| EC 3941
|
| Ms. Jani Bowe
|
| Vol #:
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| 22
|
| |
|
|
| EC 3942
|
| Dr. Donald Blake
|
| Vol #:
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| 22
|
| |
|
|
| EC 3943
|
| Miss. Charlene Kaprolet
|
| Vol #:
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| 22
|
| |
|
|
| EC 3944
|
| Miss. Whitney Helms
|
| Vol #:
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| 22
|
| |
|
|
| EC 3945
|
| Mrs. Davia Curran
|
| Vol #:
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| 22
|
| |
|
|
| EC 3946
|
| Mrs. Debra Watson
|
| Vol #:
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| 22
|
| |
|
|
| EC 3947
|
| Ms. sira melikian
|
| Vol #:
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| 22
|
| |
|
|
| EC 3948
|
| Mrs. jackie gandy
|
| Vol #:
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| 22
|
| |
|
|
| EC 3949
|
| Ms. Fran P Bonfanti
|
| Vol #:
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| 22
|
| |
|
|
| EC 3950
|
| Mrs. Kristina McKitrick
|
| Vol #:
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| 22
|
| |
|
|
| EC 3951
|
| Mr. Joe Moye
|
| Vol #:
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| 22
|
| |
|
|
| EC 3952
|
| Mr. Dean Cotelidis
|
| Vol #:
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| 22
|
| |
|
|
| EC 3953
|
| Mrs. Naoum Tsiartsionis
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3954
|
| Mrs. jen maxwell
|
| Vol #:
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| 22
|
| |
|
|
| EC 3955
|
| Dr. Beverly Timerding
|
| Vol #:
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| 22
|
| |
|
|
| EC 3956
|
| Mrs. Nancy Kolmerten
|
| Vol #:
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| 22
|
| |
|
|
| EC 3957
|
| Mrs. Jennifer Schlamb
|
| Vol #:
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| 22
|
| |
|
|
| EC 3958
|
| Ms. Kathleen Kaminske
|
| Vol #:
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| 22
|
| |
|
|
| EC 3959
|
| Miss. priscilla makhmaltchi
|
| Vol #:
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| 22
|
| |
|
|
| EC 3960
|
| Mr. P P
|
| Vol #:
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| 22
|
| |
|
|
| EC 3961
|
| Mrs. R. Winslow
|
| Vol #:
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| 22
|
| |
|
|
| EC 3962
|
| World Society for Protection of Animals (WSPA)
|
| Vol #:
|
| 22
|
| |
|
|
| EC 3963
|
| AAVS
|
| Vol #:
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| 22
|
| |
|
|
| EC 3964
|
| Ms. melanie fluharty
|
| Vol #:
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| 22
|
| |
|
|
| EC 3965
|
| Ms. Maureen Fine
|
| Vol #:
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| 22
|
|
| | | | | | | | |
|
| |
|
| EC 3966
|
| Ms. maggie xifo
|
| Vol #:
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| 22
|
| |
|
|
| EC 3967
|
| Ms. d gRIFFITH
|
| Vol #:
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| 22
|
| |
|
|
| EC 3968
|
| Mr. s love
|
| Vol #:
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| 22
|
| |
|
|
| EC 3969
|
| Miss. monica galilova
|
| Vol #:
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| 22
|
| |
|
|
| EC 3970
|
| Mrs. Norma Rathburn
|
| Vol #:
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| 22
|
| |
|
|
| EC 3971
|
| Ms. Faye Harasack
|
| Vol #:
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| 22
|
| |
|
|
| EC 3972
|
| Ms. Mary Dean
|
| Vol #:
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| 22
|
| |
|
|
| EC 3973
|
| Ms. Imogen Corcoran
|
| Vol #:
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| 22
|
| |
|
|
| EC 3974
|
| Mrs. Elise Miller
|
| Vol #:
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| 22
|
| |
|
|
| EC 3975
|
| Ms. Leonie Lacouette
|
| Vol #:
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| 22
|
| |
|
|
| EXT 10
|
| M. Mellon
|
| Vol #:
|
| 41
|
| |
|
|
| EXT 11
|
| M. Park
|
| Vol #:
|
| 41
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18279
|
| K. Langley
|
| Vol #:
|
| 198
|
| |
|
|
| C 18280
|
| D. Cole
|
| Vol #:
|
| 198
|
| |
|
|
| 2006P-0392
|
| Refrain from approving any ANDA for a Diazepam Rectal Gel that Relies on Diastat
|
| |
|
|
| C 2
|
| Valeant Pharmaceuticals International
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| FDA/CDER to Valeant Pharmaceuticals International
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| EC 1006
|
| Miss. PEYREL frydyrique
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1007
|
| Ms. Nathalie Cotel
|
| Vol #:
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| 8
|
| |
|
|
| EC 1008
|
| Miss. A Villagra
|
| Vol #:
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| 8
|
| |
|
|
| EC 1009
|
| Miss. Jennifer Boyle
|
| Vol #:
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| 8
|
| |
|
|
| EC 1010
|
| Mrs. Treez Phipps
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1011
|
| Mrs. Treez Phipps
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1012
|
| Ms. Erin Howard
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1013
|
| Mr. Robert Jeckell
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1014
|
| Miss. Coralie Fambrini
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1015
|
| Mr. Robert Stratton
|
| Vol #:
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| 8
|
| |
|
|
| EC 1016
|
| Miss. Anne-Line RAISON
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1017
|
| Ms. Cathy Foster
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1018
|
| Peta
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1019
|
| Living Vitality Nutritional Therapy
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1020
|
| Ms. Dianne Douglas
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1021
|
| Mrs. PATRICIA SIMONNOT
|
| Vol #:
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| 8
|
|
| | | | | | | |
|
| |
|
| EC 1022
|
| Mrs. April Beresford
|
| Vol #:
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| 8
|
| |
|
|
| EC 1023
|
| Mrs. Gwenda Holden
|
| Vol #:
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| 8
|
| |
|
|
| EC 1024
|
| Ms. Carla Morin
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1025
|
| Mrs. Nathalie ALONSO
|
| Vol #:
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| 8
|
|
| |
|
| EC 1026
|
| Mr. Sean and Jenny Morrisa
|
| Vol #:
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| 8
|
| |
|
|
| EC 1027
|
| Mrs. Willa Mayns
|
| Vol #:
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| 8
|
| |
|
|
| EC 1028
|
| Ms. Judith Marz
|
| Vol #:
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| 8
|
| |
|
|
| EC 1029
|
| Dr. Kamala Gollakota
|
| Vol #:
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| 8
|
| |
|
|
| EC 1030
|
| Ms. Audrey Morris
|
| Vol #:
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| 8
|
| |
|
|
| EC 1031
|
| Ms. lucy robinson
|
| Vol #:
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| 8
|
| |
|
|
| EC 1032
|
| Miss. le goff marie-laure
|
| Vol #:
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| 8
|
| |
|
|
| EC 1033
|
| Mrs. Marg White
|
| Vol #:
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| 8
|
| |
|
|
| EC 1034
|
| Mr. charlie balts
|
| Vol #:
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| 8
|
| |
|
|
| EC 1035
|
| Mrs. Sandra Sandberg
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1036
|
| REGULATION EGG CARTON LABELING
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1037
|
| Mrs. Elizabeth Mozingo
|
| Vol #:
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| 8
|
| |
|
|
| EC 1038
|
| Mrs. Amber McDonald
|
| Vol #:
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| 8
|
| |
|
|
| EC 1039
|
| Mr. Raleigh Starbuck
|
| Vol #:
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| 8
|
| |
|
|
| EC 1040
|
| Mr. Willie Bogue
|
| Vol #:
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| 8
|
| |
|
|
| EC 1041
|
| Ms. Teresa Parcell
|
| Vol #:
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| 8
|
| |
|
|
| EC 1042
|
| Miss. Valerie Brown
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1043
|
| Mr. Ken Kort
|
| Vol #:
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| 8
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| |
|
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| EC 1044
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| Mrs. Jennifer Drasch-Gerard
|
| Vol #:
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| 8
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| |
|
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| EC 1045
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| Mr. Rodney Sobin
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| Vol #:
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| 8
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| EC 1046
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| Ms. Denise Glass
|
| Vol #:
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| 8
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| |
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| EC 1047
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| Ms. Jacqueline Cordahi
|
| Vol #:
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| 8
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| |
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| EC 1048
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| Ms. Caitlin Blackinton
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| Vol #:
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| 8
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|
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| EC 1049
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| Mr. Christopher Ilg
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| Vol #:
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| 8
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| |
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| EC 1050
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| Mr. Brett Baney
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| Vol #:
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| 8
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|
| EC 1051
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| Ms. diane jimenez
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| Vol #:
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| 8
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| EC 1052
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| Mr. Sam Reggio
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| Vol #:
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| 8
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| |
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| EC 1053
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| Miss. tiffany mcdaniel
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| Vol #:
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| 8
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| |
|
|
| EC 1054
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| Miss. Laurie Fizaine
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| Vol #:
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| 8
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| |
|
|
| EC 1055
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| Mrs. Aminda Baird
|
| Vol #:
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| 8
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| |
|
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| EC 1056
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| Mr. Philip Staelens
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| Vol #:
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| 8
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| |
|
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| EC 1057
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| Mrs. Grace Froelich
|
| Vol #:
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| 8
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| |
|
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| EC 1058
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| Mr. Philip Staelens
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| Vol #:
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| 8
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| | | | | | | |
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| |
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| EC 1059
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| Mrs. Gemma Powell
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| Vol #:
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| 8
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| |
|
|
| EC 1060
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| Ms. Rachell Nickle
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| Vol #:
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| 8
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| |
|
|
| EC 1061
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| Dr. seymour gross
|
| Vol #:
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| 8
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| |
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|
| EC 1062
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| Mr. Caleb Andrus
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| Vol #:
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| 8
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| |
|
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| EC 1063
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| Mrs. Bonnie Redding
|
| Vol #:
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| 8
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| |
|
|
| EC 1064
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| Mrs. Sara Christopherson
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| Vol #:
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| 8
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| |
|
|
| EC 1065
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| Ms. Jacqueline Eckert
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| Vol #:
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| 8
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| |
|
|
| EC 1066
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| Ms. Emily Wills
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| Vol #:
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| 8
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| |
|
|
| EC 1067
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| Ms. Carolyn Bales
|
| Vol #:
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| 8
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| |
|
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| EC 1068
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| Ms. Shera Bonnie Schnitzer
|
| Vol #:
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| 8
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| |
|
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| EC 1069
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| Ms. Suzanne Powers
|
| Vol #:
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| 8
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| |
|
|
| EC 1070
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| Mr. Matthew Barrile
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| Vol #:
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| 8
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| |
|
|
| EC 1071
|
| Ms. Mary Williams
|
| Vol #:
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| 8
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| |
|
|
| EC 1072
|
| Mrs. Linda Barton
|
| Vol #:
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| 8
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| |
|
|
| EC 1073
|
| PETA
|
| Vol #:
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| 8
|
| |
|
|
| EC 1074
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| Mrs. Carrie DeMarco
|
| Vol #:
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| 8
|
| |
|
|
| EC 1075
|
| Ms. KATE HAWVERMALE
|
| Vol #:
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| 8
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| |
|
|
| EC 1076
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| cok
|
| Vol #:
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| 8
|
| |
|
|
| EC 1077
|
| Ms. Jodi Griggs
|
| Vol #:
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| 8
|
| |
|
|
| EC 1078
|
| Mrs. Sharon Engel
|
| Vol #:
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| 8
|
| |
|
|
| EC 1079
|
| Mrs. Diana Knight
|
| Vol #:
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| 8
|
| |
|
|
| EC 1080
|
| Mr. David Wallach
|
| Vol #:
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| 8
|
| |
|
|
| EC 1081
|
| Mr. Tom McGamm
|
| Vol #:
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| 8
|
| |
|
|
| EC 1082
|
| Mrs. Sandra Moyer
|
| Vol #:
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| 8
|
| |
|
|
| EC 1083
|
| Mrs. Elizabeth Kriz
|
| Vol #:
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| 8
|
| |
|
|
| EC 1084
|
| Ms. Nicole Tornatore
|
| Vol #:
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| 8
|
| |
|
|
| EC 1085
|
| Dr. Mark Feldman
|
| Vol #:
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| 8
|
| |
|
|
| EC 1086
|
| Ms. Fabiola Jaramillo
|
| Vol #:
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| 8
|
| |
|
|
| EC 1087
|
| Ms. Nicole N
|
| Vol #:
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| 8
|
| |
|
|
| EC 1088
|
| Mrs. kathleen wissenz-giacca
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1089
|
| Mr. Benjamin Safin
|
| Vol #:
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| 8
|
| |
|
|
| EC 1090
|
| Ms. Angela Dainton
|
| Vol #:
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| 8
|
| |
|
|
| EC 1091
|
| Ms. ethelda lesnic
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1092
|
| njveganfamilies@yahoo.com
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1093
|
| Miss. Anuhea Ah Yet
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1094
|
| Ms. Kate McGovern
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1095
|
| Ms. Michele McGovern
|
| Vol #:
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| 8
|
|
| | | | | | | |
|
| |
|
| EC 1096
|
| Mr. Ron Scheinberg
|
| Vol #:
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| 8
|
| |
|
|
| EC 1097
|
| Ms. Jessica Baldwin
|
| Vol #:
|
| 8
|
| |
|
|
| EC 1098
|
| Mrs. Elaine Morrissey
|
| Vol #:
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| 8
|
| |
|
|
| EC 1099
|
| Mrs. Ellen Green
|
| Vol #:
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| 8
|
| |
|
|
| EC 1100
|
| Miss. Yvette Bernstein
|
| Vol #:
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| 8
|
| |
|
|
| EC 1101
|
| Peta, COK
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1102
|
| Miss. Trudy NIX
|
| Vol #:
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| 9
|
| |
|
|
| EC 1103
|
| Ms. PROUT caroline
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1104
|
| Mrs. Kristina Sell
|
| Vol #:
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| 9
|
| |
|
|
| EC 1105
|
| Mr. Louis Sell
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1106
|
| Miss. bhargavi nagari
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1107
|
| Ms. Elizabeth Nagelin
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1108
|
| Mr. Glenn Hunter
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1109
|
| Miss. Sherri Galloway
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1110
|
| Compassion Over Killing
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1111
|
| Miss. Lorissa Keys
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1112
|
| Ms. Annette Pullen
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1113
|
| Mrs. virginia agee
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1114
|
| Ms. Jennifer Bale
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1115
|
| Ms. chloe corrigan
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1116
|
| CrueltyFree.com
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1117
|
| Ms. Vanessa Beyers
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1118
|
| Owner, Red Path Farm
|
| Vol #:
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| 9
|
| |
|
|
| EC 1119
|
| Mr. Harold Williams
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1120
|
| Mrs. Lee-Ann Westerman
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1121
|
| Mrs. Wendy Directo
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1122
|
| Mr. Dana Directo
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1123
|
| Ms. Dianne Douglas
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1124
|
| Mrs. Sarita Noel
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1125
|
| Mrs. karen ferraro
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1126
|
| Miss. Leslie Batcheller
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1127
|
| Mrs. Morgan Longo
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1128
|
| Mr. Michael Evans
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1129
|
| Ms. Madonna Niles
|
| Vol #:
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| 9
|
| |
|
|
| EC 1130
|
| Ms. Lenora Edwards
|
| Vol #:
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| 9
|
| |
|
|
| EC 1131
|
| Ms. Emily Norvaisis
|
| Vol #:
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| 9
|
| |
|
|
| EC 1132
|
| Ms. June Greenwood
|
| Vol #:
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| 9
|
|
| | | | | | | | |
|
| |
|
| EC 1133
|
| Mrs. Diana Thayer
|
| Vol #:
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| 9
|
| |
|
|
| EC 1134
|
| Mrs. Ruth Logerquist
|
| Vol #:
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| 9
|
| |
|
|
| EC 1135
|
| Ms. Sally Raymond
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1136
|
| Ms. Ann Waldron
|
| Vol #:
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| 9
|
| |
|
|
| EC 1137
|
| Mrs. Dulce Porciuncula
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1138
|
| Mrs. Liz Allen
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1139
|
| National Egg Regulatory Officials
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1140
|
| Mr. matthew dunn
|
| Vol #:
|
| 9
|
| |
|
|
| EC 1141
|
| Mrs. Stacy Oates
|
| Vol #:
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| 9
|
| |
|
|
| EC 1142
|
| Mr. keith landon
|
| Vol #:
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| 9
|
|
| |
|
| 2006P-0398
|
| Require bioequivalence studies for generic or follow-on formulations of MEGACE ES (megestrol acetate oral suspension 625 mg/5 ml)
|
| |
|
|
| LET 1
|
| FDA/CDER to Frommer Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0083
|
| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
|
|
|
|
|
|
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2007D-0101
|
| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
|
|
|
|
|
|
|
| |
|
|
| EC 2
|
| Dr. Michael Bigby
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Mrs. Rebecca Nelson
|
| Vol #:
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| 1
|
| |
|
|
| EC 4
|
| Mr. Michael Kruse
|
| Vol #:
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| 1
|
| |
|
|
| EC 5
|
| Dr. Edward Lisberg
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| Mr. Robert Wesley
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| b sachau
|
| Vol #:
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| 1
|
| |
|
|
| EC 8
|
| Dr. James Kemp
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0107
|
| P980022/S015 - Guardian REAL-Time and Paradigm REAL-Time Systems
|
| |
|
|
| AAV 1
|
| Medtronic MiniMed
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0108
|
| P060019 - Therapy Cool Path Ablation Catheter and IBI 1500T9 RF Ablation Generator
|
| |
|
|
| AAV 1
|
| Irvine Biomedical, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0109
|
| P040051 - Stelkast Surpass Acetabular System
|
| |
|
|
| AAV 1
|
| Stelkast Company
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0061
|
| Sipuleucel-T Dendreon
|
| |
|
|
| EC 106
|
| National Prostate Cancer Coalition
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EC 107
|
| Mr. David Ricketts
|
| Vol #:
|
| 1
|
| |
|
|
| EC 108
|
| Mr. Brad Hessel
|
| Vol #:
|
| 1
|
| |
|
|
| EC 109
|
| None
|
| Vol #:
|
| 1
|
| |
|
|
| EC 110
|
| After calling and at the request of the PCRI
|
| Vol #:
|
| 1
|
| |
|
|
| EC 111
|
| None
|
| Vol #:
|
| 1
|
| |
|
|
| EC 112
|
| Prostate Cancer Research Institute
|
| Vol #:
|
| 1
|
| |
|
|
| EC 113
|
| Mr. Joaquin Juan
|
| Vol #:
|
| 1
|
| |
|
|
| EC 114
|
| Dr. Nilda Roman
|
| Vol #:
|
| 1
|
| |
|
|
| EC 115
|
| TREAT IT LIKE A TEMPLE
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0090
|
| Zimulti Endocrinologic and Metabolic Drugs Advisory Committee Meeting, June 13, 2007
|
| |
|
|
| NM 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2007N-0098
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0074
|
| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
|
| |
|
|
| EC 1
|
| Mrs. Julie Casey
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Mr. Jorge Martinez
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
| |
|
|
| C 2
|
| ADM Cocoa Division, Archer Daniels Midland Co.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 1
|
| private citizen
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0116
|
| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
|
|
|
|
|
|
| | |
|
|
| ACK 1
|
| FDA/DDM to Heller Ehrmann LLP
|
| Vol #:
|
| 1
|
| |
|
|
| PSA 1
|
| Mylan Pharmaceuticals Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0119
|
| to permit an ANDA Suitability for Hydrocodone Bitartrate and Homatropine Methylbromide Syrup
|
| |
|
|
| ACK 1
|
| Lachman Consulant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| ACK 2
|
| Lachman Consulant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachman Consulant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
