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| | | | | | | | | | |
|
|
| Dockets
Entered On February 6, 2004
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
| 2000N-1531
|
| Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
| 2003D-0497
|
| Guidance for Industry on Pharmacogenomic Data Submissions
|
|
|
| 2003P-0366
|
| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
|
|
|
| 2003P-0519
|
| ANDA Suitability for Ondansetron Hydrochloride Injection and Ondansetron Hydrochloride Injection Premixed
|
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
|
|
| 2004P-0006
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
|
|
| 2004P-0055
|
| Issue a written opinion stating that Bio-Rad's longstanding practice, previously accepted by the agency, of developing unified, truthful labeling for domestic and international sales of its control pr
|
|
|
| 2004P-0056
|
| ANDA for Ondansetron Orally Disintegrating Tablets
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
|
| LET
147
|
| Bayer HealthCare (Bayer)
|
| Vol #:
|
| 235
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
| BKG
4
Reference
1-161
2nd Reference List
Reference
1-203
|
| Backgroun Material for NFR 1
|
| Vol #:
|
| 378
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 376
|
|
|
| 2000N-1449
|
| Changes to an Approved NDA or ANDA; Agency Information Collection
|
|
|
| EC 2
|
| Davis, Kelly
|
| Vol #:
|
| 1
|
|
|
| 2000N-1531
|
| Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari
|
|
|
| EXT 2
|
| Bruce Diamond, PhD
|
| Vol #:
|
| 1
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
| EMC 5762
|
| Le-Ann Di Nardo
|
| Vol #:
|
| 789
|
|
|
| EMC 5763
|
| John Mayo
|
| Vol #:
|
| 789
|
|
|
| EMC 5764
|
| Elena Arvelo
|
| Vol #:
|
| 789
|
|
|
| EMC 5765
|
| Scott Hopkins
|
| Vol #:
|
| 789
|
|
|
| EMC 5766
|
| Kathy Henley
|
| Vol #:
|
| 789
|
|
|
| EMC 5767
|
| John Mayo
|
| Vol #:
|
| 789
|
|
|
| EMC 5768
|
| John Mayo
|
| Vol #:
|
| 789
|
|
|
| 2001D-0224
|
| Mass Spectrometry for Confirmation of Identity of Animal Drug Residues
|
|
| | | | | | | | |
|
|
| EC 4
|
| Milk, Caw
|
| Vol #:
|
| 1
|
|
|
| 2002D-0124
|
| Notifying FDA of Fatalities Related to Blood & Transfusion
|
|
|
| EC 1
|
| gunter, carmen
|
| Vol #:
|
| 1
|
|
|
| 2002D-0371
|
| Human Dura Mater; Class II Special Controls Guidance
|
|
|
| EC 2
|
| rogers, jerry
|
| Vol #:
|
| 1
|
|
|
| 2003D-0092
|
| Food and Cosmetic Security Guidances
|
|
|
| EC 9
|
| Mitchell, Marvin
|
| Vol #:
|
| 1
|
|
|
| EC 11
|
| Clarfeld, Alex
|
| Vol #:
|
| 1
|
|
|
| EC 13
|
| HUMAN, BERT
|
| Vol #:
|
| 1
|
|
|
| EC 14
|
| scruggs, carol
|
| Vol #:
|
| 1
|
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
|
|
| EC 13
|
| Bolton RPh., Christine
|
| Vol #:
|
| 1
|
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
|
|
| C
3
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
|
|
| 2003D-0465
|
| Guidance for Industry on Providing Regulatory Submissions in Electronic Format b
|
|
|
| EC 2
|
| Foit, Darcy
|
| Vol #:
|
| 1
|
|
|
| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
|
|
| EC 16
|
| McCoy, Margaret
|
| Vol #:
|
| 5
|
|
|
| EC 17
|
| Knapp, Kathleen
|
| Vol #:
|
| 5
|
|
|
| EC 18
|
| Wisch, Ardythe
|
| Vol #:
|
| 5
|
|
|
| EC 19
|
| Judge, Teri
|
| Vol #:
|
| 5
|
|
|
| EC 20
|
| Burgan, Dale
|
| Vol #:
|
| 5
|
|
|
| EC 21
|
| Maugh, Jo
|
| Vol #:
|
| 5
|
|
|
| EC 22
|
| Donaldson, Karen
|
| Vol #:
|
| 5
|
|
|
| 2003D-0497
|
| Guidance for Industry on Pharmacogenomic Data Submissions
|
|
|
| C
10
|
| Bayer HealthCare (Bayer)
|
| Vol #:
|
| 1
|
|
|
| C
11
|
| Aventis Pharmaceuticals, Inc. (Aventis)
|
| Vol #:
|
| 1
|
|
|
| C
12
|
| Millennium Pharmaceuticals, Inc. (Millennium)
|
| Vol #:
|
| 1
|
|
|
| C
13
|
| Quintiles Transnational Corp.
|
| Vol #:
|
| 1
|
|
|
| C
14
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
15
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
| C
16
|
| Hoffmann-LaRoche, Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| C
17
|
| Pharmaceutical research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
|
|
| C
18
|
| Wyeth Pharmaceuticals (Wyeth)
|
| Vol #:
|
| 1
|
|
|
| C
19
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
|
|
| C
20
|
| Global Genomics AB
|
| Vol #:
|
| 1
|
|
|
| 2003F-0535
|
| Chlorine Dioxide (FAP 4A4751)
|
|
|
| EC 1
|
| Wencl, Ollie
|
| Vol #:
|
| 1
|
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
| EC 145
|
| Lantz, Kurt
|
| Vol #:
|
| 10
|
|
|
| EC 146
|
| Belval, Nicole
|
| Vol #:
|
| 10
|
|
|
| EC 147
|
| Hackemer, Mary Anne
|
| Vol #:
|
| 10
|
|
|
| EC 148
|
| Lincoln, Terry
|
| Vol #:
|
| 10
|
|
|
| EC 149
|
| Korsmo, Jill
|
| Vol #:
|
| 10
|
|
|
| EC 150
|
| Carden, Danny
|
| Vol #:
|
| 10
|
|
|
| EC 151
|
| cattellion, carine
|
| Vol #:
|
| 10
|
|
|
| EC 152
|
| Weber, Dennis
|
| Vol #:
|
| 10
|
|
|
| EC 153
|
| Jakopak, James
|
| Vol #:
|
| 10
|
|
|
| EC 154
|
| Gompf, Sandra
|
| Vol #:
|
| 10
|
|
|
| EC 155
|
| DeVillers, Roberta
|
| Vol #:
|
| 10
|
|
|
| EC 156
|
| Fried, Danielle
|
| Vol #:
|
| 10
|
|
|
| EC 157
|
| Glasser, william
|
| Vol #:
|
| 10
|
|
|
| EC 158
|
| Matuszewski, Christy
|
| Vol #:
|
| 10
|
|
|
| EC 159
|
| Strommen, Ed
|
| Vol #:
|
| 10
|
|
|
| EC 160
|
| Shanahan, Kari
|
| Vol #:
|
| 10
|
|
|
| EC 161
|
| Nishiyama, Marie
|
| Vol #:
|
| 10
|
|
|
| EC 162
|
| Pastore, Marge
|
| Vol #:
|
| 10
|
|
|
| EC 163
|
| Walker, Ken
|
| Vol #:
|
| 10
|
|
|
| EC 164
|
| eastham, harry
|
| Vol #:
|
| 10
|
|
|
| EC 165
|
| Watson, Ed
|
| Vol #:
|
| 10
|
|
|
| EC 166
|
| Geislinger, Eric
|
| Vol #:
|
| 10
|
|
|
| EC 167
|
| Holt, Errol
|
| Vol #:
|
| 10
|
|
|
| EC 168
|
| burcaw, lindsay
|
| Vol #:
|
| 10
|
|
|
| EC 169
|
| Flint, Eric
|
| Vol #:
|
| 10
|
|
|
| EC 170
|
| Claypool, Tristan
|
| Vol #:
|
| 10
|
|
|
| EC 171
|
| Doerfler, Debra
|
| Vol #:
|
| 10
|
|
|
| EC 172
|
| Deremer, Nicole
|
| Vol #:
|
| 10
|
|
| | | | | | | |
|
|
| EC 173
|
| Rudd, Yvette
|
| Vol #:
|
| 10
|
|
|
| EC 174
|
| Boivin, William
|
| Vol #:
|
| 10
|
|
|
| EC 175
|
| Wardwell, Amber
|
| Vol #:
|
| 10
|
|
|
| EC 176
|
| Salmonson, Jessica
|
| Vol #:
|
| 10
|
|
|
| EC 177
|
| Desio, Kimberly
|
| Vol #:
|
| 10
|
|
|
| EC 178
|
| JUng, Adam
|
| Vol #:
|
| 10
|
|
|
| EC 179
|
| MILLET, Aude
|
| Vol #:
|
| 10
|
|
|
| EC 180
|
| wood, alan
|
| Vol #:
|
| 10
|
|
|
| EC 181
|
| Piersa, Kristen
|
| Vol #:
|
| 10
|
|
|
| EC 182
|
| Davis, Chuck
|
| Vol #:
|
| 10
|
|
|
| EC 183
|
| Taylor, Julianna
|
| Vol #:
|
| 10
|
|
|
| EC 184
|
| Walker, Ken
|
| Vol #:
|
| 10
|
|
|
| EC 185
|
| Merchant, Christine
|
| Vol #:
|
| 10
|
|
|
| EC 186
|
| Davidson, Sandra
|
| Vol #:
|
| 10
|
|
|
| EC 187
|
| Richards, Susan
|
| Vol #:
|
| 10
|
|
|
| EC 188
|
| Stiebel, Danielle
|
| Vol #:
|
| 10
|
|
|
| EC 189
|
| Strange, Marie
|
| Vol #:
|
| 10
|
|
|
| EC 190
|
| Strange, Samantha
|
| Vol #:
|
| 10
|
|
|
| EC 191
|
| Strange, Greg
|
| Vol #:
|
| 10
|
|
|
| EC 192
|
| O`Neall, Gregory
|
| Vol #:
|
| 10
|
|
|
| EC 193
|
| Steinman, Francis
|
| Vol #:
|
| 10
|
|
|
| EC 194
|
| Conger, Jaimie
|
| Vol #:
|
| 10
|
|
|
| EC 195
|
| cattellion, carine
|
| Vol #:
|
| 10
|
|
|
| EC 196
|
| lewis, terri
|
| Vol #:
|
| 10
|
|
|
| EC 197
|
| Maffucci, Allison
|
| Vol #:
|
| 10
|
|
|
| EC 198
|
| Kohut, Matthew
|
| Vol #:
|
| 10
|
|
|
| EC 199
|
| Baker, Shari
|
| Vol #:
|
| 10
|
|
|
| EC 200
|
| Khalsa, Dharam Damama
|
| Vol #:
|
| 10
|
|
|
| EC 201
|
| Berk, Marilyn
|
| Vol #:
|
| 10
|
|
|
| EC 202
|
| Higgins, Jess
|
| Vol #:
|
| 10
|
|
|
| EC 203
|
| Galle, Victoria
|
| Vol #:
|
| 10
|
|
|
| EC 204
|
| Campbell, Leah
|
| Vol #:
|
| 10
|
|
|
| EC 205
|
| Derwin, Danielle
|
| Vol #:
|
| 10
|
|
|
| EC 206
|
| Killmer, Jennifer
|
| Vol #:
|
| 10
|
|
|
| EC 207
|
| Paulson, Andrew
|
| Vol #:
|
| 10
|
|
|
| EC 208
|
| Maynor, Teresa
|
| Vol #:
|
| 10
|
|
|
| EC 209
|
| Harless, Travis
|
| Vol #:
|
| 10
|
|
| | | | | | | |
|
|
| EC 210
|
| Schaunaman, Lori
|
| Vol #:
|
| 10
|
|
|
| EC 211
|
| TRIX, DIANE
|
| Vol #:
|
| 10
|
|
|
| EC 212
|
| Johnson, Chris
|
| Vol #:
|
| 10
|
|
|
| EC 213
|
| Douglas, Duff
|
| Vol #:
|
| 10
|
|
|
| EC 214
|
| Cerqua, Natalie
|
| Vol #:
|
| 10
|
|
|
| EC 215
|
| Winters, Bonnie
|
| Vol #:
|
| 10
|
|
|
| EC 216
|
| Gorsuch, Tricia
|
| Vol #:
|
| 10
|
|
|
| EC 217
|
| Houston, Ranae
|
| Vol #:
|
| 10
|
|
|
| EC 218
|
| Newson, Roger
|
| Vol #:
|
| 10
|
|
|
| EC 219
|
| Shenkle, karen
|
| Vol #:
|
| 10
|
|
|
| EC 220
|
| Jackson, Linda
|
| Vol #:
|
| 10
|
|
|
| EC 221
|
| Troxell, Tina
|
| Vol #:
|
| 10
|
|
|
| EC 222
|
| Bard, Becky
|
| Vol #:
|
| 10
|
|
|
| EC 223
|
| O'Neill, Tom
|
| Vol #:
|
| 10
|
|
|
| EC 224
|
| Stoffel, Tim
|
| Vol #:
|
| 10
|
|
|
| EC 225
|
| Haskett, Debbie
|
| Vol #:
|
| 10
|
|
|
| EC 226
|
| Sellers, K
|
| Vol #:
|
| 10
|
|
|
| EC 227
|
| Prezio, Laura
|
| Vol #:
|
| 10
|
|
|
| EC 228
|
| Ivester, Suzanne
|
| Vol #:
|
| 10
|
|
|
| EC 229
|
| Hintz, Ann
|
| Vol #:
|
| 10
|
|
|
| EC 230
|
| McCarty, Greg
|
| Vol #:
|
| 10
|
|
|
| EC 231
|
| cattellion, carine
|
| Vol #:
|
| 10
|
|
|
| EC 232
|
| Brennan, Patricia
|
| Vol #:
|
| 10
|
|
|
| EC 233
|
| Haddock, Joann
|
| Vol #:
|
| 10
|
|
|
| EC 234
|
| Gaskins, D.
|
| Vol #:
|
| 10
|
|
|
| EC 235
|
| McClanahan, Christina
|
| Vol #:
|
| 10
|
|
|
| EC 236
|
| Peters, Candace
|
| Vol #:
|
| 10
|
|
|
| EC 237
|
| White, Kim
|
| Vol #:
|
| 10
|
|
|
| EC 238
|
| Peters, Stephen
|
| Vol #:
|
| 10
|
|
|
| EC 239
|
| Brough, Clarice
|
| Vol #:
|
| 10
|
|
|
| EC 240
|
| Seaberg, Gena
|
| Vol #:
|
| 10
|
|
|
| EC 241
|
| Seaberg, Gena
|
| Vol #:
|
| 10
|
|
|
| EC 242
|
| Seaberg, Gena
|
| Vol #:
|
| 10
|
|
|
| EC 243
|
| Seaberg, Gena
|
| Vol #:
|
| 10
|
|
|
| EC 244
|
| Shaw, Jasen
|
| Vol #:
|
| 10
|
|
|
| EC 245
|
| Pariser, Aaron
|
| Vol #:
|
| 10
|
|
|
| EC 246
|
| Watts, Andrew
|
| Vol #:
|
| 10
|
|
| | | | | | | |
|
|
| EC 247
|
| Romano, Anthony
|
| Vol #:
|
| 10
|
|
|
| EC 248
|
| Verplank, Jenifer
|
| Vol #:
|
| 10
|
|
|
| EC 249
|
| Pfab, Shelley
|
| Vol #:
|
| 10
|
|
|
| EC 250
|
| Litt, Aaron
|
| Vol #:
|
| 10
|
|
|
| EC 251
|
| Stanton, Sue
|
| Vol #:
|
| 10
|
|
|
| EC 252
|
| Jung, Holly
|
| Vol #:
|
| 10
|
|
|
| EC 253
|
| Jackson, James
|
| Vol #:
|
| 10
|
|
|
| EC 254
|
| Gorman, Sarah
|
| Vol #:
|
| 10
|
|
|
| EC 255
|
| Kulp-Shorten, Carol
|
| Vol #:
|
| 10
|
|
|
| EC 256
|
| Zolitor, Lynn
|
| Vol #:
|
| 10
|
|
|
| EC 257
|
| Golden, Nancy
|
| Vol #:
|
| 10
|
|
|
| EC 258
|
| Bryant, Jessica
|
| Vol #:
|
| 10
|
|
|
| EC 259
|
| Raim, Michael
|
| Vol #:
|
| 10
|
|
|
| EC 260
|
| Hromanik, Dawn
|
| Vol #:
|
| 10
|
|
|
| EC 261
|
| James, Jesse
|
| Vol #:
|
| 10
|
|
|
| EC 262
|
| Boroff, Tina
|
| Vol #:
|
| 10
|
|
|
| EC 263
|
| Maxwell, Herald
|
| Vol #:
|
| 10
|
|
|
| EC 264
|
| Willems, Vicky
|
| Vol #:
|
| 10
|
|
|
| EC 265
|
| Harless, Anita
|
| Vol #:
|
| 10
|
|
|
| EC 266
|
| Hertz, Ira
|
| Vol #:
|
| 10
|
|
|
| EC 267
|
| Abell, Charles
|
| Vol #:
|
| 10
|
|
|
| EC 268
|
| MARTIN, Cheyenne
|
| Vol #:
|
| 10
|
|
|
| EC 269
|
| Haskett, Debbie
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| Vol #:
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| 10
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|
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| EC 270
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| Gleisser, Linda
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| Vol #:
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| 10
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| EC 271
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| Graves, Pat
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| Vol #:
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| 10
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|
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| EC 272
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| Jung, Adam
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| Vol #:
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| 10
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|
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| EC 273
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| Harrison, Dennis
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| Vol #:
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| 10
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|
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| EC 274
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| Maynard, Arlene
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| Vol #:
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| 10
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|
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| EC 275
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| Hawkins, Brenda
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| Vol #:
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| 10
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|
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| EC 276
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| davis, nancy
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| Vol #:
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| 10
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|
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| EC 277
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| Metzel, Ashley
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| Vol #:
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| 10
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|
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| EC 278
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| Wynn, Julianna
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| Vol #:
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| 10
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|
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| EC 279
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| Maffucci, Alllison
|
| Vol #:
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| 10
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|
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| EC 280
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| McDonald, Maureen
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| Vol #:
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| 10
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|
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| EC 281
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| Maffucci, Jeannine
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| Vol #:
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| 10
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|
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| EC 282
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| Presser, Bonnie
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| Vol #:
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| 10
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|
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| EC 283
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| Haskett, Haven
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| Vol #:
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| 10
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| EC 284
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| Walker, deborah
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| Vol #:
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| 10
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| EC 285
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| DeMarco, Andrea
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| Vol #:
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| 10
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|
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| EC 286
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| Hulsey, Carrie
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| Vol #:
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| 10
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|
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| EC 287
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| Van Beemen, Annie
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| Vol #:
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| 10
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|
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| EC 288
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| Horne, Janel
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| Vol #:
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| 10
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| EC 289
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| Schmitt, Janet
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| Vol #:
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| 10
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| EC 290
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| Henderson, Patricia
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| Vol #:
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| 10
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| EC 291
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| SHELTON, PENNIE
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| Vol #:
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| 10
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| EC 292
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| Peterson, David
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| Vol #:
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| 10
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| EC 293
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| Demel, Hanna
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| Vol #:
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| 10
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| EC 294
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| Harrison, Lynn
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| Vol #:
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| 10
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| EC 295
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| bently, becca
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| Vol #:
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| 10
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| EC 296
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| Kosolosky, Nancy
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| Vol #:
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| 10
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| EC 297
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| Blair, Rhonda
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| Vol #:
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| 10
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|
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| EC 298
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| STIDOM, SUZETTE
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| Vol #:
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| 10
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| EC 299
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| Perkins, Cheryl
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| Vol #:
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| 10
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| EC 300
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| Howell, Amanda
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| Vol #:
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| 10
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| EC 301
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| Lind, Charlotte
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| Vol #:
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| 10
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|
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| EC 302
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| Letton, Lucy
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| Vol #:
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| 10
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|
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| EC 303
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| Forbes, Michaele
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| Vol #:
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| 10
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|
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| EC 304
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| Pelt, Woody
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| Vol #:
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| 10
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|
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| EC 305
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| Winfield, Crystalynn
|
| Vol #:
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| 10
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|
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| EC 306
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| Knight, Ronnie
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| Vol #:
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| 10
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|
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| EC 307
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| Vasquez, Dnaleri
|
| Vol #:
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| 10
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|
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| EC 308
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| Winfield-Vasquez, Khayman
|
| Vol #:
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| 10
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|
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| EC 309
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| Lenz, Donna
|
| Vol #:
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| 10
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|
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| EC 310
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| Anonymous, Anonymous
|
| Vol #:
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| 10
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|
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| EC 311
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| Gotting, Rebecca
|
| Vol #:
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| 10
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|
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| EC 312
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| Weisenberg, Tiffany
|
| Vol #:
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| 10
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|
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| EC 313
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| Nelson, Teela
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| Vol #:
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| 10
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|
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| EC 314
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| Martin, Jeannette
|
| Vol #:
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| 10
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|
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| EC 315
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| Gladden, Scott
|
| Vol #:
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| 10
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|
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| EC 316
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| Gilligan, Gretchen
|
| Vol #:
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| 10
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|
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| EC 317
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| Ohnmacht, Kristin
|
| Vol #:
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| 10
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|
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| EC 318
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| rusick, amy
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| Vol #:
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| 10
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|
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| EC 319
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| Prichard, Pam
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| Vol #:
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| 10
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| EC 320
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| Savage, Linda
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| Vol #:
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| 10
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| EC 321
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| Johnson, Robert
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| Vol #:
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| 10
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|
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| EC 322
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| Finocchiaro, Mary Beth
|
| Vol #:
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| 10
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|
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| EC 323
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| Hoffmann, Robert
|
| Vol #:
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| 10
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|
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| EC 324
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| Butler, Cindy
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| Vol #:
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| 10
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|
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| EC 325
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| Cox, Deborah
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| Vol #:
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| 10
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|
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| EC 326
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| Knapp, Shelly
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| Vol #:
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| 10
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| EC 327
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| Boudreaux, Yvonne
|
| Vol #:
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| 10
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|
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| EC 328
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| Jung, Adam
|
| Vol #:
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| 10
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| EC 329
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| Taylor, David
|
| Vol #:
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| 10
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|
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| EC 330
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| Derwin, Merriam
|
| Vol #:
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| 10
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|
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| EC 331
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| Scardina , Jenniffer
|
| Vol #:
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| 10
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|
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| EC 332
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| Rebrovich, Joann
|
| Vol #:
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| 10
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|
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| EC 333
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| Stringfellow, Jennifer
|
| Vol #:
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| 10
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|
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| EC 334
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| Lester, Kendra
|
| Vol #:
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| 10
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|
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| EC 335
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| cattellion, carine
|
| Vol #:
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| 10
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|
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| EC 336
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| Close, Char.
|
| Vol #:
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| 10
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|
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| EC 337
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| Knapp, Scott
|
| Vol #:
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| 10
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|
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| EC 338
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| Burgoyne, S
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| Vol #:
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| 10
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|
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| EC 339
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| Reid, Catherine
|
| Vol #:
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| 10
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|
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| EC 340
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| STYGA, DAWN
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| Vol #:
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| 10
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|
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| EC 341
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| Watson, Billie
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| Vol #:
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| 10
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|
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| EC 342
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| Anderson, Ashley
|
| Vol #:
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| 10
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|
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| EC 343
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| King, Julie
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| Vol #:
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| 10
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|
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| EC 344
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| Pot, Fien
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| Vol #:
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| 10
|
|
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| EC 345
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| walton, kay
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| Vol #:
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| 10
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|
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| EC 346
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| Feyen, Kristien
|
| Vol #:
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| 10
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|
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| EC 347
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| McKee Sr., Mark
|
| Vol #:
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| 10
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|
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| EC 348
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| Smith, Jane
|
| Vol #:
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| 10
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|
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| EC 349
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| Grace, John
|
| Vol #:
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| 10
|
|
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| EC 350
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| teabo, coleen
|
| Vol #:
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| 10
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|
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| EC 351
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| Wills, Sandra
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| Vol #:
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| 10
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|
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| EC 352
|
| Stringfellow, Michael
|
| Vol #:
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| 10
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|
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| EC 353
|
| Olufsen, Helene
|
| Vol #:
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| 10
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|
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| EC 354
|
| burke, john
|
| Vol #:
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| 10
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|
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| EC 355
|
| Milliken IV, Charles F
|
| Vol #:
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| 10
|
|
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| EC 356
|
| Sanders, Lisa
|
| Vol #:
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| 10
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|
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| EC 357
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| Minor, Richard
|
| Vol #:
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| 10
|
|
| | | | | | | |
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| EC 358
|
| cattellion, carine
|
| Vol #:
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| 10
|
|
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| EC 359
|
| Liddick, Matthew
|
| Vol #:
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| 10
|
|
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| EC 360
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| Hanson, Tonya
|
| Vol #:
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| 10
|
|
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| EC 361
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| Hansen, Carl
|
| Vol #:
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| 10
|
|
|
| EC 362
|
| Goodenough, Shelly
|
| Vol #:
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| 10
|
|
|
| EC 363
|
| kbjghggg, Merenbhvcjhblknhckbh
|
| Vol #:
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| 10
|
|
|
| EC 364
|
| turnbull, tony
|
| Vol #:
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| 10
|
|
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| EC 365
|
| Casner, Alex
|
| Vol #:
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| 10
|
|
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| EC 366
|
| McCormick, Linda
|
| Vol #:
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| 10
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|
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| EC 367
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| DuBuque, Anna
|
| Vol #:
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| 10
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|
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| EC 368
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| Davidson, Ana
|
| Vol #:
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| 10
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|
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| EC 369
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| Paulus, Kathy
|
| Vol #:
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| 10
|
|
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| EC 370
|
| Baptista, Diane
|
| Vol #:
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| 10
|
|
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| EC 371
|
| Parmely, Kevin
|
| Vol #:
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| 10
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|
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| EC 372
|
| Cattellion, Carine
|
| Vol #:
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| 10
|
|
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| EC 373
|
| Guysi, George S.
|
| Vol #:
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| 10
|
|
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| EC 374
|
| rusick, amy
|
| Vol #:
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| 10
|
|
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| EC 375
|
| Westphal, Richard
|
| Vol #:
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| 10
|
|
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| EC 376
|
| Poznich, Tom
|
| Vol #:
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| 10
|
|
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| EC 377
|
| Lucchetti, Lynn
|
| Vol #:
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| 10
|
|
|
| EC 378
|
| MOORE, RAHONDA
|
| Vol #:
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| 10
|
|
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| EC 379
|
| Turnbull, Carol
|
| Vol #:
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| 10
|
|
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| EC 380
|
| Biggs, Cindy
|
| Vol #:
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| 10
|
|
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| EC 381
|
| James, Dani Lee
|
| Vol #:
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| 10
|
|
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| EC 382
|
| Watson, Lynda
|
| Vol #:
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| 10
|
|
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| EC 383
|
| James, Dianne A.
|
| Vol #:
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| 10
|
|
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| EC 384
|
| Deck, Becky
|
| Vol #:
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| 10
|
|
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| EC 385
|
| peterpaul, maya
|
| Vol #:
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| 10
|
|
|
| EC 386
|
| Derwin, Danielle
|
| Vol #:
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| 10
|
|
|
| EC 387
|
| Lind, Charlotte
|
| Vol #:
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| 10
|
|
|
| EC 388
|
| cattellion, carine
|
| Vol #:
|
| 10
|
|
|
| EC 389
|
| Jung, Adam
|
| Vol #:
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| 10
|
|
|
| EC 390
|
| rusick, amy
|
| Vol #:
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| 10
|
|
|
| EC 391
|
| Haskett, Deborah
|
| Vol #:
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| 10
|
|
|
| EC 392
|
| Lamb, Susan
|
| Vol #:
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| 10
|
|
|
| EC 393
|
| Haskett, Haven
|
| Vol #:
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| 10
|
|
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| EC 394
|
| Sarver-Brown, Sally
|
| Vol #:
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| 10
|
|
| | | | | | | |
|
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| EC 395
|
| Kronk, Stacey
|
| Vol #:
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| 10
|
|
|
| EC 396
|
| cattellion, carine
|
| Vol #:
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| 10
|
|
|
| EC 397
|
| Brown, John
|
| Vol #:
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| 10
|
|
|
| EC 398
|
| Brown, Sally
|
| Vol #:
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| 10
|
|
|
| EC 399
|
| Boroff, Tina
|
| Vol #:
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| 10
|
|
|
| EC 400
|
| Maffucci, Allison
|
| Vol #:
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| 10
|
|
|
| EC 401
|
| Behnke, Steven
|
| Vol #:
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| 10
|
|
|
| EC 402
|
| Verplank, Jenifer
|
| Vol #:
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| 10
|
|
|
| EC 403
|
| Loetscher, Sara
|
| Vol #:
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| 10
|
|
|
| EC 404
|
| Unan, Mel
|
| Vol #:
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| 10
|
|
|
| EC 405
|
| Baney, MJ
|
| Vol #:
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| 10
|
|
|
| EC 406
|
| Lind, Charlotte
|
| Vol #:
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| 10
|
|
|
| EC 407
|
| Rebrovich, Daryl
|
| Vol #:
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| 10
|
|
|
| EC 408
|
| Bard, Becky
|
| Vol #:
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| 10
|
|
|
| EC 409
|
| Breakey, Mary Beth
|
| Vol #:
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| 10
|
|
|
| EC 410
|
| Enderle, Judith
|
| Vol #:
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| 10
|
|
|
| EC 411
|
| Arcilise, Nick
|
| Vol #:
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| 10
|
|
|
| EC 412
|
| Piatanesi, Lisa
|
| Vol #:
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| 10
|
|
|
| EC 413
|
| Schreurs, Jeroen
|
| Vol #:
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| 10
|
|
|
| EC 414
|
| Pixley, Amy
|
| Vol #:
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| 10
|
|
|
| EC 415
|
| Crimbring, Sara
|
| Vol #:
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| 10
|
|
|
| EC 416
|
| johnson, chris
|
| Vol #:
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| 10
|
|
|
| EC 417
|
| Flores, Cynthia
|
| Vol #:
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| 10
|
|
|
| EC 418
|
| Jacobs, Robert
|
| Vol #:
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| 10
|
|
|
| EC 419
|
| SCHERER, steven
|
| Vol #:
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| 10
|
|
|
| EC 420
|
| Moore, Kerri
|
| Vol #:
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| 10
|
|
|
| EC 421
|
| Conner, Sheila C.
|
| Vol #:
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| 10
|
|
|
| EC 422
|
| Campbell, Jennifer L.A
|
| Vol #:
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| 10
|
|
|
| EC 423
|
| Ellington, Penni G.
|
| Vol #:
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| 10
|
|
|
| EC 424
|
| Payton, Robert
|
| Vol #:
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| 10
|
|
|
| EC 425
|
| cattellion, carine
|
| Vol #:
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| 10
|
|
|
| EC 426
|
| Howard, Sheri
|
| Vol #:
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| 10
|
|
|
| EC 427
|
| Schnell, Tracy
|
| Vol #:
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| 10
|
|
|
| EC 428
|
| Campbell, Jay
|
| Vol #:
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| 10
|
|
|
| EC 429
|
| Steskal, Ricky
|
| Vol #:
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| 10
|
|
|
| EC 430
|
| Edlin, Linnea
|
| Vol #:
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| 10
|
|
|
| EC 431
|
| Guerrero, Lori
|
| Vol #:
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| 10
|
|
| | | | | | | | |
|
|
| EC 432
|
| Blanco, Katherine
|
| Vol #:
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| 10
|
|
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| EC 433
|
| Schnell, Tracy
|
| Vol #:
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| 10
|
|
|
| EC 434
|
| Korsmo, Jill
|
| Vol #:
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| 10
|
|
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| EC 435
|
| Olufsen, Helene
|
| Vol #:
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| 10
|
|
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| EC 437
|
| Carpenter, Marre
|
| Vol #:
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| 10
|
|
|
| EC 438
|
| MILLER, Aude K.
|
| Vol #:
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| 10
|
|
|
| EC 439
|
| briggs'bradley, janet
|
| Vol #:
|
| 10
|
|
|
| EC 440
|
| Schnell, Tracy
|
| Vol #:
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| 10
|
|
|
| EC 441
|
| Prichard, Pam
|
| Vol #:
|
| 10
|
|
|
| 2003P-0366
|
| Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
|
|
|
| SUP
3
|
| Mylan Phamaceuticals, Inc. (Mylan)
|
| Vol #:
|
| 1
|
|
|
| 2003P-0519
|
| ANDA Suitability for Ondansetron Hydrochloride Injection and Ondansetron Hydrochloride Injection Premixed
|
|
|
| AMD
1
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
| C
1
|
| Hyman, Phelps & McNamara, PC
|
| Vol #:
|
| 1
|
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
|
|
| C 4
|
| B. Kaufmann
|
| Vol #:
|
| 1
|
|
|
| C 5
|
| M. Argast
|
| Vol #:
|
| 1
|
|
|
| C 6
|
| J. Head
|
| Vol #:
|
| 1
|
|
|
| C 7
|
| S. Berryman
|
| Vol #:
|
| 1
|
|
|
| C 8
|
| A. Yuenger
|
| Vol #:
|
| 1
|
|
|
| C 9
|
| D. Liewellyn
|
| Vol #:
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| 1
|
|
|
| C 10
|
| J. LaForge
|
| Vol #:
|
| 1
|
|
|
| C 11
|
| M. Berrigan
|
| Vol #:
|
| 1
|
|
|
| C 12
|
| G. Larkin
|
| Vol #:
|
| 1
|
|
|
| C 13
|
| M. Bauman
|
| Vol #:
|
| 1
|
|
|
| C 14
|
| Form Letters
|
| Vol #:
|
| 2
|
|
|
| C 15
|
| Form Letters
|
| Vol #:
|
| 3
|
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
|
|
| C 1
|
| R. Beltramini
|
| Vol #:
|
| 1
|
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
|
|
| TR
1
|
| Workshop on Factor VIII Inhibitors held on 11/21/2003
|
| Vol #:
|
| 3
|
|
|
| TS
1
|
| HFM-300
|
| Vol #:
|
| 1
|
|
|
| TS
2
|
| HFM-340
|
| Vol #:
|
| 1
|
|
|
| TS 3
|
| J. Remy,MD,PhD
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| TS 4
|
| S. Raut
|
| Vol #:
|
| 1
|
|
|
| TS 5
|
| B. Verbruggen
|
| Vol #:
|
| 1
|
|
|
| TS 6
|
| G. White, MD
|
| Vol #:
|
| 1
|
|
|
| TS
7
|
| Assn of Hemophilia Clinic Directors of Canada (AHCDC)
|
| Vol #:
|
| 1
|
|
|
| TS
8
|
| National Center on Birth Defects and Development Disabilities
|
| Vol #:
|
| 1
|
|
|
| TS
9
|
| Paul Ehrlich Institute
|
| Vol #:
|
| 1
|
|
|
| TS
10
|
| HFM-392
|
| Vol #:
|
| 2
|
|
|
| TS
11
|
| HFM-217
|
| Vol #:
|
| 2
|
|
|
| TS 12
|
| L. Aledort, MD
|
| Vol #:
|
| 2
|
|
|
| TS 13
|
| B. Ewenstein,MD,PhD
|
| Vol #:
|
| 2
|
|
|
| TS
14
|
| Bayer HealthCare
|
| Vol #:
|
| 2
|
|
|
| TS
15
|
| Octagen Corporation
|
| Vol #:
|
| 2
|
|
|
| TS
16
|
| Wyeth
|
| Vol #:
|
| 2
|
|
|
| TS 17
|
| D. DiMichele, MD
|
| Vol #:
|
| 2
|
|
|
| 2004P-0006
|
| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
|
|
| C
2
|
| Teva Pharmaceuticals USA, Inc. (Teva)
|
| Vol #:
|
| 2
|
|
|
| 2004P-0055
|
| Issue a written opinion stating that Bio-Rad's longstanding practice, previously accepted by the agency, of developing unified, truthful labeling for domestic and international sales of its control pr
|
|
|
|
|
|
| ACK 1
|
| HFA-305 to Bio-Rad Laboratories
|
| Vol #:
|
| 1
|
|
|
| CP
1
Tab
1, 2, 3
|
| Bio-Rad Laboratories
|
| Vol #:
|
| 1
|
|
|
| 2004P-0056
|
| ANDA for Ondansetron Orally Disintegrating Tablets
|
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|