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| Dockets Entered
On March 26, 2004
Table of Contents
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| Docket #
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| Title
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2004P-0148
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| ANDA Suitability for Oxycodone Hydrochloride 5 mg, 10 mg and 20 mg tablets
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| 2004P-0149
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| ANDA Suitability for 2.5 mg oxycodone hydrochloride/325 mg acetaminophen and 5 mg oxycodone hydrochloride/325 mg acetaminophen
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| 2004P-0150
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| ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 1078
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| O. Greenhaw
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| Vol #:
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| 207
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| C 1079
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| Illegible
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| Vol #:
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| 207
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| C 1080
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| K. Ballertine
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| Vol #:
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| 207
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| C 1081
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| M. Glidewell
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| Vol #:
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| 207
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| C 1082
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| C. Richardson
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| Vol #:
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| 207
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| C 1083
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| Illegible
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| Vol #:
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| 207
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| C 1084
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| Illegible
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| Vol #:
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| 207
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| C 1085
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| Illegible
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| Vol #:
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| 207
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| C 1086
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| Illegible
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| Vol #:
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| 207
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| C 1087
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| Illegible
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| Vol #:
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| 207
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| C 1088
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| J. Finn
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| Vol #:
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| 207
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| C 1089
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| D. Wieseler
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| Vol #:
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| 207
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| C 1090
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| R. Myerscough
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| Vol #:
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| 207
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| C 1091
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| Illegible
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| Vol #:
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| 207
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| C 1092
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| J. Blanchard
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| Vol #:
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| 207
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| C 1093
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| J. Cohen
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| Vol #:
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| 207
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| C 1094
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| No signature
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| Vol #:
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| 207
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| C 1095
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| M. Whedbee
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| Vol #:
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| 207
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| C 1096
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| C. Walters
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| Vol #:
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| 207
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| C 1097
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| D. Varado
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| Vol #:
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| 207
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| C 1098
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| N. Allen
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| Vol #:
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| 207
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| C 1099
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| Illegible
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| Vol #:
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| 207
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| C 1100
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| S. Costanzo
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| Vol #:
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| 207
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| C 1101
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| T. Lozina
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| Vol #:
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| 207
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| C 1102
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| B. Daley
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| Vol #:
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| 207
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| C 1103
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| A. DiNardo
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| Vol #:
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| 207
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| C 1104
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| No signature
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| Vol #:
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| 207
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| C 1105
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| M. Oswald
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| Vol #:
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| 207
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| C 1106
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| V. Peters
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| Vol #:
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| 207
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| C 1107
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| Mr and Mrs D. Post
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| Vol #:
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| 207
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| C 1108
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| Illegible
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| Vol #:
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| 207
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| C 1109
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| Illegible
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| Vol #:
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| 207
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| C 1110
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| S. Loveall
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| Vol #:
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| 207
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| C 1111
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| K. Sprout
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| Vol #:
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| 207
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| C 1112
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| Illegible
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| Vol #:
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| 207
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| C 1113
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| L. Andree
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| Vol #:
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| 207
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| C 1114
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| Illegible
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| Vol #:
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| 207
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| C 1115
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| E. Rocco
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| Vol #:
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| 207
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| C 1116
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| J and D Smith
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| Vol #:
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| 207
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| C 1117
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| M. Nathe
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| Vol #:
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| 207
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| C 1118
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| S. Raspallo
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| Vol #:
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| 207
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| C 1119
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| E. Morris
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| Vol #:
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| 207
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| C 1120
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| M. Ostrowski
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| Vol #:
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| 207
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| C 1121
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| C. Eklund
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| Vol #:
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| 207
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| C 1122
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| J. Cash
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| Vol #:
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| 207
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| C 1123
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| J. Weisz
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| Vol #:
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| 207
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| C 1124
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| P. Engesser
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| Vol #:
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| 207
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| C 1125
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| M. Coughlin
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| Vol #:
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| 207
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| C 1126
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| Illegible
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| Vol #:
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| 207
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| C 1127
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| Illegible
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| Vol #:
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| 207
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| C 1128
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| J. Windnazel
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| Vol #:
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| 207
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| C 1129
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| Illegible
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| Vol #:
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| 207
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| C 1130
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| M. Hunt
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| Vol #:
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| 207
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| C 1131
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| A. Curwick
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| Vol #:
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| 207
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| C 1132
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| Illegible
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| Vol #:
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| 207
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| C 1133
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| N. Anilo
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| Vol #:
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| 207
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| C 1134
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| Illegible
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| Vol #:
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| 207
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| C 1135
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| D. Bowlin
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| Vol #:
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| 207
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| C 1136
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| L. Moses, M.Ed
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| Vol #:
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| 207
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| C 1137
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| Illegible
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| Vol #:
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| 207
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| C 1138
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| M. Wieder
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| Vol #:
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| 207
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| C 1139
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| J. Doran
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| Vol #:
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| 207
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| C 1140
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| D. Conover
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| Vol #:
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| 207
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| C 1141
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| S. Kurtzhals
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| Vol #:
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| 207
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| C 1142
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| No signature
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| Vol #:
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| 207
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| C 1143
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| G. Albano
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| Vol #:
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| 207
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| C 1144
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| Illegible
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| Vol #:
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| 207
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| C 1145
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| E. Gentilella
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| Vol #:
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| 207
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| C 1146
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| C. Incitt
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| Vol #:
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| 207
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| C 1147
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| E. Eagar
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| Vol #:
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| 207
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| C 1148
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| J. DeMaggio
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| Vol #:
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| 207
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| C 1149
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| W. Reed
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| Vol #:
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| 207
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| C 1150
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| C. Keyl
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| Vol #:
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| 207
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| C 1151
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| J. Elliott
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| Vol #:
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| 208
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| C 1152
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| A. Walsh
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| Vol #:
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| 208
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| C 1153
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| S. Parsley
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| Vol #:
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| 208
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| C 1154
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| L. Welch
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| Vol #:
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| 208
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| C 1155
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| C. Chapman
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| Vol #:
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| 208
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| C 1156
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| J. Nelson
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| Vol #:
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| 208
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| C 1157
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| B. Beaver
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| Vol #:
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| 208
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| C 1158
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| D and L Kadelak
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| Vol #:
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| 208
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| C 1159
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| Illegible
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| Vol #:
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| 208
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| C 1160
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| D. Phillips
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| Vol #:
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| 208
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| C 1161
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| L. Luley
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| Vol #:
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| 208
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| C 1162
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| E. Zeidler
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| Vol #:
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| 208
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| C 1163
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| M. Pankey
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| Vol #:
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| 208
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| C 1164
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| A. Pearson
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| Vol #:
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| 208
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| C 1165
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| N. Keil
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| Vol #:
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| 208
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| C 1166
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| K. Stoll
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| Vol #:
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| 208
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| C 1167
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| S. Dirnbeck
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| Vol #:
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| 208
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| C 1168
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| T. Hogan
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| Vol #:
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| 208
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| C 1169
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| M. Cassout
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| Vol #:
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| 208
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| C 1170
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| P. Fortner
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| Vol #:
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| 208
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| C 1171
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| B. Boblink
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| Vol #:
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| 208
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| C 1172
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| J. McLaughlin
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| Vol #:
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| 208
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| C 1173
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| R. Mellady
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| Vol #:
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| 208
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| C 1174
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| S. Murphy
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| Vol #:
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| 208
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| C 1175
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| J. Linde
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| Vol #:
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| 208
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| C 1176
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| N. Osborne
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| Vol #:
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| 208
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| C 1177
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| H. Leen
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| Vol #:
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| 208
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| C 1178
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| J. Rurelle
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| Vol #:
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| 208
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| C 1179
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| A. Sigillito
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| Vol #:
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| 208
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| C 1180
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| M. Stell
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| Vol #:
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| 208
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| C 1181
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| S. Fisher
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| Vol #:
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| 208
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| C 1182
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| S. Wauen
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| Vol #:
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| 208
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| C 1183
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| B. Stoll
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| Vol #:
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| 208
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| C 1184
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| C. McHugh
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| Vol #:
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| 208
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| C 1185
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| S. Exum
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| Vol #:
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| 208
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| C 1186
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| E. Eichler
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| Vol #:
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| 208
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| C 1187
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| J. Crunican
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| Vol #:
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| 208
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| C 1188
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| V. Hill
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| Vol #:
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| 208
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| C 1189
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| P. Macey
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| Vol #:
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| 208
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| C 1190
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| S. Morrissey
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| Vol #:
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| 208
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| C 1191
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| P. Russo
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| Vol #:
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| 208
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| C 1192
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| P. Johnston
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| Vol #:
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| 208
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| C 1193
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| J. Hild
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| Vol #:
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| 208
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| C 1194
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| H. Hagerman, Jr.
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| Vol #:
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| 208
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| C 1195
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| C. Hartford
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| Vol #:
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| 208
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| C 1196
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| M. Cooper
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| Vol #:
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| 208
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| C 1197
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| K. Tague
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| Vol #:
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| 208
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| C 1198
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| C. Stalder
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| Vol #:
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| 208
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| C 1199
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| K. Houlihan
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| Vol #:
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| 208
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| C 1200
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| M. Meyer
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| Vol #:
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| 208
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| C 1201
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| C. Bextermiller
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| Vol #:
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| 208
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| C 1202
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| C. Dobbeke
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| Vol #:
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| 208
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| C 1203
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| D. Varner
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| Vol #:
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| 208
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| C 1204
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| J and K Joyce
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| Vol #:
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| 208
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| C 1205
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| A. Estrado
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| Vol #:
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| 208
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| C 1206
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| J. Westphal
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| Vol #:
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| 208
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| C 1207
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| M. Arendes
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| Vol #:
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| 208
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| C 1208
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| M. Estenfeld
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| Vol #:
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| 208
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| C 1209
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| E. Miller
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| Vol #:
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| 208
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| C 1210
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| L. Marcella
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| Vol #:
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| 208
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| C 1211
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| P. Puopolo
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| Vol #:
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| 208
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| C 1212
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| V. Gooding
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| Vol #:
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| 208
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| C 1213
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| D. Goodwin
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| Vol #:
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| 208
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| C 1214
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| M. Carey
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| Vol #:
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| 208
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| C 1215
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| K. Hughes
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| Vol #:
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| 208
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| C 1216
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| J. Farrell
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| Vol #:
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| 208
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| C 1217
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| D. Gall
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| Vol #:
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| 208
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| C 1218
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| B and E. Smith
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| Vol #:
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| 208
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| C 1219
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| A. Kunzweller
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| Vol #:
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| 208
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| |
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| C 1220
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| Illegible
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| Vol #:
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| 208
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| |
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| C 1221
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| R. Sextro
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| Vol #:
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| 208
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| |
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| C 1222
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| P. Hogan
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| Vol #:
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| 208
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| C 1223
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| K. Waeker
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| Vol #:
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| 208
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| C 1224
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| R. Ampleman
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| Vol #:
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| 208
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| |
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| C 1225
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| Illegible
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| Vol #:
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| 208
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| |
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| C 1226
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| D. Stoll
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| Vol #:
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| 208
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| C 1227
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| J. Stoll
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| Vol #:
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| 208
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| |
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| C 1228
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| Illegible
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| Vol #:
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| 208
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| |
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| C 1229
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| J. Muller
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| Vol #:
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| 208
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| |
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| C 1230
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| G. Warren
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| Vol #:
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| 208
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| C 1231
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| L. Kane
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| Vol #:
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| 208
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| |
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| C 1232
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| M. Munzer
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| Vol #:
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| 208
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| |
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| C 1233
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| C. Gurule
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| Vol #:
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| 208
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| C 1234
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| M. Stuber
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| Vol #:
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| 208
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| C 1235
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| P. Bierschbach
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| Vol #:
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| 208
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| |
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| C 1236
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| J. Schneider
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| Vol #:
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| 208
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| C 1237
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| Illegible
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| Vol #:
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| 208
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| |
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| C 1238
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| O. Sigillito
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| Vol #:
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| 208
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| C 1239
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| M. Branco
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| Vol #:
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| 208
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| C 1240
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| M. Glavinick
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| Vol #:
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| 208
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| |
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| C 1241
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| V. Curry
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| Vol #:
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| 208
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| |
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| C 1242
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| Mr and Mrs R. Warner
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| Vol #:
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| 208
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| |
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| C 1243
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| A. McCarthy
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| Vol #:
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| 208
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| |
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| C 1244
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| U. Berry
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| Vol #:
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| 208
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| |
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| C 1245
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| M. Kern
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| Vol #:
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| 208
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| |
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| C 1246
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| V. Fox
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| Vol #:
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| 208
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| |
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| C 1247
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| D. Griesenauer
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| Vol #:
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| 208
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| |
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| C 1248
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| E. Pay
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| Vol #:
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| 208
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| |
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| C 1249
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| J. Guidry,DMD
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| Vol #:
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| 208
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| |
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| C 1250
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| B. Glass
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| Vol #:
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| 208
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| |
|
|
| C 1251
|
| W. Lemieux
|
| Vol #:
|
| 209
|
| |
|
|
| C 1252
|
| P. Eixenberger
|
| Vol #:
|
| 209
|
| |
|
|
| C 1253
|
| L. Basta
|
| Vol #:
|
| 209
|
| |
|
|
| C 1254
|
| L. Schaufler
|
| Vol #:
|
| 209
|
| |
|
|
| C 1255
|
| M. Martle
|
| Vol #:
|
| 209
|
|
| | | | | | | |
| |
|
|
| C 1256
|
| R. Weber
|
| Vol #:
|
| 209
|
| |
|
|
| C 1257
|
| E. White
|
| Vol #:
|
| 209
|
| |
|
|
| C 1258
|
| D. Mellody
|
| Vol #:
|
| 209
|
| |
|
|
| C 1259
|
| A. Kohnen
|
| Vol #:
|
| 209
|
| |
|
|
| C 1260
|
| Mr and Mrs M. Schiavoni
|
| Vol #:
|
| 209
|
| |
|
|
| C 1261
|
| E. Heithaus
|
| Vol #:
|
| 209
|
| |
|
|
| C 1262
|
| A. Mellady
|
| Vol #:
|
| 209
|
| |
|
|
| C 1263
|
| M. Skinner
|
| Vol #:
|
| 209
|
| |
|
|
| C 1264
|
| L. Reilly
|
| Vol #:
|
| 209
|
| |
|
|
| C 1265
|
| Illegible
|
| Vol #:
|
| 209
|
| |
|
|
| C 1266
|
| G. Hirmann
|
| Vol #:
|
| 209
|
| |
|
|
| C 1267
|
| M. Montogomery
|
| Vol #:
|
| 209
|
| |
|
|
| C 1268
|
| I. Doherty
|
| Vol #:
|
| 209
|
| |
|
|
| C 1269
|
| U. Healy
|
| Vol #:
|
| 209
|
| |
|
|
| C 1270
|
| Mr and Mrs J. Stachowiak, Jr.
|
| Vol #:
|
| 209
|
| |
|
|
| C 1271
|
| S. Mahan
|
| Vol #:
|
| 209
|
| |
|
|
| C 1272
|
| D. Willette
|
| Vol #:
|
| 209
|
| |
|
|
| C 1273
|
| N. Beiriger
|
| Vol #:
|
| 209
|
| |
|
|
| C 1274
|
| V and A Pribil
|
| Vol #:
|
| 209
|
| |
|
|
| C 1275
|
| J. Booth
|
| Vol #:
|
| 209
|
| |
|
|
| C 1276
|
| M. Hogue
|
| Vol #:
|
| 209
|
| |
|
|
| C 1277
|
| Illegible
|
| Vol #:
|
| 209
|
| |
|
|
| C 1278
|
| J. Pilliod
|
| Vol #:
|
| 209
|
| |
|
|
| C 1279
|
| J. Hubert
|
| Vol #:
|
| 209
|
| |
|
|
| C 1280
|
| E and T Daley
|
| Vol #:
|
| 209
|
| |
|
|
| C 1281
|
| W. Riedford
|
| Vol #:
|
| 209
|
| |
|
|
| C 1282
|
| J. Clooney
|
| Vol #:
|
| 209
|
| |
|
|
| C 1283
|
| M. Wagner
|
| Vol #:
|
| 209
|
| |
|
|
| C 1284
|
| M. Bierschbach
|
| Vol #:
|
| 209
|
| |
|
|
| C 1285
|
| D. Hodgden
|
| Vol #:
|
| 209
|
| |
|
|
| C 1286
|
| J. Heady
|
| Vol #:
|
| 209
|
| |
|
|
| C 1287
|
| R. Ulich
|
| Vol #:
|
| 209
|
| |
|
|
| C 1288
|
| J. Rovelle
|
| Vol #:
|
| 209
|
| |
|
|
| C 1289
|
| V. Montgomery
|
| Vol #:
|
| 209
|
| |
|
|
| C 1290
|
| No signature
|
| Vol #:
|
| 209
|
| |
|
|
| C 1291
|
| M. Dyer
|
| Vol #:
|
| 209
|
| |
|
|
| C 1292
|
| L. Meng
|
| Vol #:
|
| 209
|
|
| | | | | | | |
| |
|
|
| C 1293
|
| L. Rutkay
|
| Vol #:
|
| 209
|
| |
|
|
| C 1294
|
| L. Mellady
|
| Vol #:
|
| 209
|
| |
|
|
| C 1295
|
| J. McKray
|
| Vol #:
|
| 209
|
| |
|
|
| C 1296
|
| P. Woodside
|
| Vol #:
|
| 209
|
| |
|
|
| C 1297
|
| J. Wampler
|
| Vol #:
|
| 209
|
| |
|
|
| C 1298
|
| J. McKray
|
| Vol #:
|
| 209
|
| |
|
|
| C 1299
|
| B. Woessner
|
| Vol #:
|
| 209
|
| |
|
|
| C 1300
|
| R. Woessner
|
| Vol #:
|
| 209
|
| |
|
|
| C 1301
|
| M. Ward
|
| Vol #:
|
| 209
|
| |
|
|
| C 1302
|
| G. Flanagan
|
| Vol #:
|
| 209
|
| |
|
|
| C 1303
|
| 305 signatures
|
| Vol #:
|
| 209
|
| |
|
|
| C 1304
|
| M. Plog,PhD
|
| Vol #:
|
| 209
|
| |
|
|
| C 1305
|
| L. Garfinkel
|
| Vol #:
|
| 209
|
| |
|
|
| C 1306
|
| Z. Cater
|
| Vol #:
|
| 209
|
| |
|
|
| C 1307
|
| A. Even
|
| Vol #:
|
| 209
|
| |
|
|
| C 1308
|
| J. Vilimek
|
| Vol #:
|
| 209
|
| |
|
|
| C 1309
|
| J. Iannotta
|
| Vol #:
|
| 209
|
| |
|
|
| C 1310
|
| M. Bortell
|
| Vol #:
|
| 209
|
| |
|
|
| C 1311
|
| J. Graham
|
| Vol #:
|
| 209
|
| |
|
|
| C 1312
|
| H. Silverding
|
| Vol #:
|
| 209
|
| |
|
|
| C 1313
|
| P. Tanzini
|
| Vol #:
|
| 209
|
| |
|
|
| C 1314
|
| S. Leith,MD
|
| Vol #:
|
| 209
|
| |
|
|
| C 1315
|
| V. Sullivan
|
| Vol #:
|
| 209
|
| |
|
|
| C 1316
|
| G. Blinstrub
|
| Vol #:
|
| 209
|
| |
|
|
| C 1317
|
| V. Denz
|
| Vol #:
|
| 209
|
| |
|
|
| C 1318
|
| B. Carr
|
| Vol #:
|
| 209
|
| |
|
|
| C 1319
|
| M. Mizin
|
| Vol #:
|
| 209
|
| |
|
|
| C 1320
|
| B. Grum
|
| Vol #:
|
| 209
|
| |
|
|
| C 1321
|
| M. Schmorr
|
| Vol #:
|
| 209
|
| |
|
|
| C 1322
|
| 10 signatures
|
| Vol #:
|
| 209
|
| |
|
|
| C 1323
|
| P. Wheeler
|
| Vol #:
|
| 209
|
| |
|
|
| C 1324
|
| K. Fisher
|
| Vol #:
|
| 209
|
| |
|
|
| C 1325
|
| C. Morr
|
| Vol #:
|
| 209
|
| |
|
|
| C 1326
|
| V. Kearney
|
| Vol #:
|
| 209
|
| |
|
|
| C 1327
|
| Illegible
|
| Vol #:
|
| 209
|
| |
|
|
| C 1328
|
| P. Sigillito
|
| Vol #:
|
| 209
|
| |
|
|
| C 1329
|
| N. Herold
|
| Vol #:
|
| 209
|
|
| | | | | | | | |
| |
|
|
| C 1330
|
| J. Puckett
|
| Vol #:
|
| 209
|
| |
|
|
| C 1331
|
| A. Olesh
|
| Vol #:
|
| 209
|
| |
|
|
| C 1332
|
| J. Kline
|
| Vol #:
|
| 209
|
| |
|
|
| EMC 5301
|
| R. Stout
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5302
|
| W. F. Schreiber
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5303
|
| L. Wawrzonek
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5304
|
| S. Tracy
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5305
|
| C. Cerulli
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5306
|
| J. Efron
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5307
|
| M. Mackenzine
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5308
|
| R. Ostroff
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5309
|
| P. Quiana
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5310
|
| A. Kushner
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5311
|
| H. K. Kolbe
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5312
|
| J. Savasta
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5313
|
| O. Blobel
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5314
|
| Wanda Rahmani
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5315
|
| W. Rahmani
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5316
|
| K. Logan
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5317
|
| R. Kenyon
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5318
|
| L. Schwarz
|
| Vol #:
|
| 210
|
| |
|
|
| EMC 5319
|
| R. Guberman
|
| Vol #:
|
| 210
|
| |
|
|
| 2004P-0148
|
| ANDA Suitability for Oxycodone Hydrochloride 5 mg, 10 mg and 20 mg tablets
|
| |
|
|
| ACK 1
|
| HFA-305 to The Weinberg Group Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Attachment 1,
2, 3
|
| The Weinberg Group Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0149
|
| ANDA Suitability for 2.5 mg oxycodone hydrochloride/325 mg acetaminophen and 5 mg oxycodone hydrochloride/325 mg acetaminophen
|
| |
|
|
| ACK 1
|
| HFA-305 to Endo Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Attachment
1, 2, 3,
4
|
| Endo Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0150
|
| ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen
|
| |
|
|
| ACK 1
|
| HFA-305 to Endo Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Attachment
1, 2, 3,
4
|
| Endo Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
