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| Dockets Entered
On March 2, 2004
Table of Contents
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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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| |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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| 2001P-0333
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| Non-lyophilized Cytoxan
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| 2003D-0522
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| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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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-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| 2003P-0126
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| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0321
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| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2003P-0387
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| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
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| 2003Q-0401
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| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
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| 2004M-0090
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| H030003, DeBakey VAD Child Left Ventricular Assist System
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| 2004V-0095
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
12892
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| Bionutripharm Systems Inc.
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| Vol #:
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| 105
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| LET
12893
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| Health From The Sun
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| Vol #:
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| 105
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| LET
12894
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| Savvier,Inc.
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| Vol #:
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| 105
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| LET
12895
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| Dr. Walter Smith's Get Thin Program
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| Vol #:
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| 105
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| LET
12896
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| Dr. Smith's Get Thin Program
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| Vol #:
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| 105
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| LET
12897
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| Atkins Nutritionals, Inc.
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| Vol #:
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| 105
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| LET
12898
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| Atkins Nutritionals, Inc.
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| Vol #:
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| 105
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| LET
12899
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| Atkins Nutritionals, Inc.
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| Vol #:
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| 105
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| LET
12900
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| Source Naturals
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| Vol #:
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| 105
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| LET
12901
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| Market America, Inc.
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| Vol #:
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| 105
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| LET
12902
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| Wellness International Netrwork, Ltd.
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| Vol #:
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| 105
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| LET
12903
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| Source Naturals
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| Vol #:
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| 105
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| LET
12904
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| Perrigo Company of South Carolina
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| Vol #:
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| 105
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| LET
12905
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| Trilogy International Inc.
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| Vol #:
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| 105
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| LET
12906
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| Yves Rocher North America, Inc.
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| Vol #:
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| 105
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| LET
12907
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| Twin Laboratories Inc.
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| Vol #:
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| 105
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| LET
12908
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| Awareness Corporation
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| Vol #:
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| 105
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| LET
12909
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 105
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| LET
12910
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| EuroPharma, Inc.
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| Vol #:
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| 105
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| LET
12911
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| EuroPharma, Inc.
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| Vol #:
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| 105
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| LET
12912
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| EuroPharma, Inc.
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| Vol #:
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| 105
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| LET
12913
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| EuroPharma, Inc.
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| Vol #:
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| 105
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| LET
12914
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| EuroPharma,Inc.
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| Vol #:
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| 105
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| LET
12915
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| EuroPharma, Inc.
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| Vol #:
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| 105
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| LET
12916
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| EuroPharma, Inc.
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| Vol #:
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| 105
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| LET
12917
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 105
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| LET
12918
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 105
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| LET
12919
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 105
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| LET
12920
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 105
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| LET
12921
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 105
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| LET
12922
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 105
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|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EMC 3030
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| R. Kerr
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| Vol #:
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| 165
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| EMC 3031
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| J. McCoy
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| Vol #:
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| 165
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| EMC 3032
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| F. Mann
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| Vol #:
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| 165
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| EMC 3033
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| M. k. Young
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| Vol #:
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| 165
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| EMC 3034
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| M. Gochnauer
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| Vol #:
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| 165
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| EMC 3035
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| Ms. R. Scott
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| Vol #:
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| 165
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| EMC 3036
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| Rev. B.J. Doucet
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| Vol #:
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| 165
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| EMC 3037
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| K. Tripplett
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| Vol #:
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| 165
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| EMC 3038
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| V. Cowie
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| Vol #:
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| 165
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| EMC 3039
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| S. Schachat
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| Vol #:
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| 165
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| EMC 3040
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| Z. Fellows
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| Vol #:
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| 165
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| EMC 3041
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| S. Jones
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| Vol #:
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| 165
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| EMC 3042
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| C. Ciocchetti
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| Vol #:
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| 165
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| EMC 3043
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| A. Beckner
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| Vol #:
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| 165
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| EMC 3044
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| J. Gorrell
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| Vol #:
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| 165
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| EMC 3045
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| C. Rush
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| Vol #:
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| 165
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| EMC 3046
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| H. Hacker
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| Vol #:
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| 165
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| EMC 3047
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| J. Meissner
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| Vol #:
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| 165
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| EMC 3048
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| M. K.
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| Vol #:
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| 165
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| EMC 3049
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| A. Fellows
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| Vol #:
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| 165
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| EMC 3050
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| E. Katzman
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| Vol #:
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| 165
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| EMC 3051
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| A. Maynard
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| Vol #:
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| 165
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| EMC 3052
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| E. Harting
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| Vol #:
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| 165
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| EMC 3053
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| D. Carter
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| Vol #:
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| 165
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| EMC 3054
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| P. Salmans
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| Vol #:
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| 165
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| EMC 3055
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| J. Hisrich
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| Vol #:
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| 165
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| EMC 3056
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| S. Davis
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| Vol #:
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| 165
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| EMC 3057
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| B. MacKenzie
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| Vol #:
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| 165
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| EMC 3058
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| C. Tuovinen
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| Vol #:
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| 165
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| EMC 3059
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| T. Robischon
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| Vol #:
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| 165
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| EMC 3060
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| J. Darrouzet
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| Vol #:
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| 165
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| EMC 3061
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| L. Drucker
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| Vol #:
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| 165
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| EMC 3062
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| S. Hess
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| Vol #:
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| 165
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| EMC 3063
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| E. Winston
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| Vol #:
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| 165
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| EMC 3064
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| C. Byl
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| Vol #:
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| 165
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| EMC 3065
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| D. Deevey
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| Vol #:
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| 165
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| EMC 3066
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| D. Adams
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| Vol #:
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| 165
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| EMC 3067
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| P. Packer
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| Vol #:
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| 165
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| EMC 3068
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| M. Diebels
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| Vol #:
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| 165
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| EMC 3069
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| D. DeSha
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| Vol #:
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| 165
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| EMC 3070
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| D. Athey
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| Vol #:
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| 165
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| EMC 3071
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| G. Smith
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| Vol #:
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| 165
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| EMC 3072
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| R. S. Salmon
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| Vol #:
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| 165
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| EMC 3073
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| J. Cresseveur
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| Vol #:
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| 165
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| EMC 3074
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| L. Biggs
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| Vol #:
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| 165
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| EMC 3075
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| C. Shaw
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| Vol #:
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| 165
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| EMC 3076
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| S. Dunn
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| Vol #:
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| 165
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| EMC 3077
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| D. Elsensohn
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| Vol #:
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| 165
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| EMC 3078
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| E. Hudson
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| Vol #:
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| 165
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| EMC 3079
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| M. Leapman
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| Vol #:
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| 165
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| EMC 3080
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| J. Wood
|
| Vol #:
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| 165
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| EMC 3081
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| A. Ruph
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| Vol #:
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| 165
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| EMC 3082
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| L. Schoomaker
|
| Vol #:
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| 165
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| EMC 3083
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| D. Bashkow
|
| Vol #:
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| 165
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| EMC 3084
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| M. Welsh
|
| Vol #:
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| 165
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| EMC 3085
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| J. Howard
|
| Vol #:
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| 165
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| EMC 3086
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| K. Griffin
|
| Vol #:
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| 165
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| EMC 3087
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| J. Woolley
|
| Vol #:
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| 165
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| EMC 3088
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| C. Burton
|
| Vol #:
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| 165
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| EMC 3089
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| S. Trivisonno
|
| Vol #:
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| 165
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| EMC 3090
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| P. Seafos
|
| Vol #:
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| 165
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| EMC 3091
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| R. Foster
|
| Vol #:
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| 165
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| EMC 3092
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| J. Lyman
|
| Vol #:
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| 165
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| EMC 3093
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| T. Meyer
|
| Vol #:
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| 165
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| EMC 3094
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| N. Brennan
|
| Vol #:
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| 165
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| EMC 3095
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| B. Curlin
|
| Vol #:
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| 165
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| EMC 3096
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| C. Morningsong
|
| Vol #:
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| 165
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| EMC 3097
|
| T. Ramirez
|
| Vol #:
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| 165
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| EMC 3098
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| M. Lesher
|
| Vol #:
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| 165
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| EMC 3099
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| C. Gilfillan
|
| Vol #:
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| 165
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| EMC 3100
|
| A. Kozubov
|
| Vol #:
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| 165
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| EMC 3101
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| C. Crusha
|
| Vol #:
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| 165
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| EMC 3102
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| J. Wiles
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| Vol #:
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| 165
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| EMC 3103
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| N. Newton
|
| Vol #:
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| 165
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| EMC 3104
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| K. Fellezs
|
| Vol #:
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| 165
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| EMC 3105
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| K. Evans
|
| Vol #:
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| 165
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| EMC 3106
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| M. Hendriksen
|
| Vol #:
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| 165
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| |
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| EMC 3107
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| S. Malek
|
| Vol #:
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| 165
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| EMC 3108
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| J. Gilland
|
| Vol #:
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| 165
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| EMC 3109
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| A. Schmidt
|
| Vol #:
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| 165
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| EMC 3110
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| E. G. Cates
|
| Vol #:
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| 165
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| |
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| EMC 3111
|
| J. Lamb
|
| Vol #:
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| 165
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| EMC 3112
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| L. Sheldon
|
| Vol #:
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| 165
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| |
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| EMC 3113
|
| F. Hillyard
|
| Vol #:
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| 165
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| |
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| EMC 3114
|
| K. Babiak
|
| Vol #:
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| 165
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| EMC 3115
|
| C. McPherron
|
| Vol #:
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| 165
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| |
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| EMC 3116
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| A. M. Joyner
|
| Vol #:
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| 165
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| |
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| EMC 3117
|
| G. Cass
|
| Vol #:
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| 165
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| |
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| EMC 3118
|
| R. Williams
|
| Vol #:
|
| 165
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| |
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| EMC 3119
|
| H. Frank
|
| Vol #:
|
| 165
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| |
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| EMC 3120
|
| T. Rafiq
|
| Vol #:
|
| 165
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| |
|
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| EMC 3121
|
| H. Andersen
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3122
|
| D. Tokarz
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3123
|
| L. Millhous
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3124
|
| K. R.
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3125
|
| J. Robinson
|
| Vol #:
|
| 165
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| |
|
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| EMC 3126
|
| D. Kirschner
|
| Vol #:
|
| 165
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| | | | | | | |
| |
|
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| EMC 3127
|
| D. Lewis
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3128
|
| H. Stucke
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3129
|
| P. Rottmann
|
| Vol #:
|
| 165
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| |
|
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| EMC 3130
|
| C. Heinz
|
| Vol #:
|
| 165
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| |
|
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| EMC 3131
|
| P. Taylor
|
| Vol #:
|
| 165
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| |
|
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| EMC 3132
|
| R. E. Clements
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3133
|
| B. Russell
|
| Vol #:
|
| 165
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| |
|
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| EMC 3134
|
| K Alexander-Brown
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3135
|
| S. Deyo
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3136
|
| J. Oggenfuss
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3137
|
| B. Gregory
|
| Vol #:
|
| 165
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| |
|
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| EMC 3138
|
| R. Buckles
|
| Vol #:
|
| 165
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| |
|
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| EMC 3139
|
| N. Bomberg
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3140
|
| M. Difiore
|
| Vol #:
|
| 165
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| |
|
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| EMC 3141
|
| C. Pooler
|
| Vol #:
|
| 165
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| |
|
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| EMC 3142
|
| L. Lundy
|
| Vol #:
|
| 165
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| |
|
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| EMC 3143
|
| R. Kilbourn
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3144
|
| D. Epstein
|
| Vol #:
|
| 165
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| |
|
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| EMC 3145
|
| S. Jones
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3146
|
| B. E. Fortini
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3147
|
| D. Martin
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3148
|
| D. Anacleto
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3149
|
| M. Manchester
|
| Vol #:
|
| 165
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| |
|
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| EMC 3150
|
| M. Cullen
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3151
|
| S. Malik
|
| Vol #:
|
| 165
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| |
|
|
| EMC 3152
|
| E. Harsh
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3153
|
| S. Swigert
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3154
|
| L. Ciulla
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3155
|
| K. Badey
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3156
|
| M. L. Bratt
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3157
|
| C. A. Wendt
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3158
|
| B. Williamson-Pecori
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3159
|
| R. Beeker
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3160
|
| R. Clarker-Smith
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3161
|
| P. Larch
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3162
|
| G. A. Brown
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3163
|
| L. Mithcell
|
| Vol #:
|
| 165
|
|
| | | | | | | | |
| |
|
|
| EMC 3164
|
| A. Friandaca
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3165
|
| D. Crowne
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3166
|
| L. Waters
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3167
|
| E. Reisman
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3168
|
| R. Montoya
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3169
|
| M. Rausch
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3170
|
| A. Smith
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3171
|
| J. Womble
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3172
|
| D. Wullenwaber
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3173
|
| E. Novaski
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3174
|
| L. Walker
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3175
|
| K. Geronime
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3176
|
| M. L. Hall
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3177
|
| M. McCollum
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3178
|
| M. j. Zeh
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3179
|
| M. Drake
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3180
|
| K. Jackson
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3181
|
| B. Whatmough
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3182
|
| G. & H. Azarva
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3183
|
| N. Stone
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3184
|
| S. Mithcell
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3185
|
| M. Grayson
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3186
|
| C. Lotito
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3187
|
| R. Rugh
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3188
|
| Y. Diaz
|
| Vol #:
|
| 165
|
| |
|
|
| EMC 3189
|
| M. Marriott
|
| Vol #:
|
| 165
|
| |
|
|
| 2001P-0333
|
| Non-lyophilized Cytoxan
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0522
|
| Draft Guidance for Industry and FDA Staff; Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests; Availability
|
| |
|
|
| C
4
|
| LifePoint, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003H-0432
|
| Civil Money Penalty, Korangy Radiology Associates, PA
|
| |
|
|
| LET
4
|
| Korangy Radiology Associates,
et al.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| NEC
1
|
| FDA
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| C
80
Attachment
|
| Creating GreenPiece.com
|
| Vol #:
|
| 9
|
| |
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
| |
|
|
| C
16
|
| Archer Daniels Midland Company (ADM)
|
| Vol #:
|
| 6
|
| |
|
|
| C
17
|
| American Herbal Products Assn (AHPA)
|
| Vol #:
|
| 6
|
| |
|
|
| C
18
|
| Grocery Manufacturers of America (GMA)
|
| Vol #:
|
| 6
|
| |
|
|
| C
19
|
| Grocery Manufacturers of America et al.
|
| Vol #:
|
| 6
|
| |
|
|
| C
20
|
| Juice Products Assn (JPA)
|
| Vol #:
|
| 6
|
| |
|
|
| C
21
|
| CSPI et al.
|
| Vol #:
|
| 6
|
| |
|
|
| C
22
|
| National Milk Producers Federation (NMPF)
|
| Vol #:
|
| 6
|
| |
|
|
| C
23
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 6
|
| |
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
|
|
| SUP
3
Tab A, CV
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
| |
|
|
| C 48
|
| Dr. L. Pesteanu
|
| Vol #:
|
| 6
|
| |
|
|
| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
|
| |
|
|
| LET
4
|
| Valeant Pharmaceuticals International
|
| Vol #:
|
| 3
|
| |
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
| |
|
|
| LET
2
|
| HFD-005 to Abbott Laboratories
|
| Vol #:
|
| 3
|
| |
|
|
| SUP
4
Tab A,
CV
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 3
|
| |
|
|
| 2003Q-0401
|
| Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
|
| |
|
|
| C
4
|
| America Heart Association
|
| Vol #:
|
| 2
|
| |
|
|
| C
5
|
| Council for Responsible Nutrition
|
| Vol #:
|
| 7
|
| |
|
|
| C
6
|
| American Longevity Inc, Life Extenison Foundation Buyers Club Inc
|
| Vol #:
|
| 10
|
| |
|
|
| 2004M-0090
|
| H030003, DeBakey VAD Child Left Ventricular Assist System
|
| |
|
|
| AAV
1
|
| MicroMed Technology, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004V-0095
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to Club Lotus
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Club Lotus
|
| Vol #:
|
| 1
|
|
|
