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| Dockets Entered
On May 16, 2006
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006E-0206
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| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
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| 2006N-0181
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| Product Stability Data: Notice of Pilot Project
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0205
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| Require Vitamin D be added to cereal-grain products
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| 2006P-0207
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| ANDA Suitability for Cetirizine Hydrochloride Soft Gelatin Capsules 5mg and 10mg
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| 2006P-0208
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| Permit the filing of an ANDA for Loratadine Soft Gelatin Capsules 10mg
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| 1976N-0052N
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| OTC Nasal Decongestants
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| C 250
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| Wyeth Consumer Heathcare
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| Vol #:
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| 98
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|
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| C 128
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| Wyeth Consumer Healthcare
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| Vol #:
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| 110
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|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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|
| LET 17621
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| New Product Development Sedona Laboratories, Inc.
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| Vol #:
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| 162
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| LET 17622
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| Arizona Pharmaceuticals, LLC
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| Vol #:
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| 162
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| LET 17623
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| Enzymatic Therapy
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| Vol #:
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| 162
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|
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| LET 17624
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| Enzymatic Therapy
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| Vol #:
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| 162
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|
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| LET 17625
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| Enzymatic Therapy
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| Vol #:
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| 162
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|
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| LET 17626
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| Perrigo Company of South Carolina
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| Vol #:
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| 162
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|
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| LET 17627
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| Perrigo Company of South Carolina
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| Vol #:
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| 162
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|
|
| LET 17628
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| Perrigo Company of South Carolina
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| Vol #:
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| 162
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|
|
| LET 17629
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| Perrigo Company of South Carolina
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| Vol #:
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| 162
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|
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| LET 17630
|
| EarthLab, Inc.dba Wise Woman Herbals
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| Vol #:
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| 162
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|
|
| LET 17631
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| EarthLab, Inc. dba Wise Woman Herbals
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| Vol #:
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| 162
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|
|
| LET 17632
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| EarthLab, Inc. dba Wise Woman Herbals
|
| Vol #:
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| 162
|
|
|
| LET 17633
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| EarthLab, Inc. dba Wise Woman Herbals
|
| Vol #:
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| 162
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|
|
| LET 17634
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| EarthLab, Inc. dba Wise Woman Herbals
|
| Vol #:
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| 162
|
|
|
| LET 17635
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| Advanced Metabolics Research Group
|
| Vol #:
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| 162
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|
| | | | | | | | |
|
|
| LET 17636
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| Perrigo Company of South Carolina
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| Vol #:
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| 162
|
|
|
| LET 17637
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| Perrigo Company of South Carolina
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| Vol #:
|
| 162
|
|
|
| LET 17638
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 162
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| C 18269
|
| G. Schuenemann
|
| Vol #:
|
| 516
|
|
|
| C 18270
|
| J. Schuenemann
|
| Vol #:
|
| 516
|
|
|
| C 18271
|
| L. Chamberlain, D.O.
|
| Vol #:
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| 516
|
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
|
|
| C 12863
|
| G. Schuenemann
|
| Vol #:
|
| 806
|
|
|
| C 12864
|
| J. Schuenemann
|
| Vol #:
|
| 806
|
|
|
| C 12865
|
| L. Chamberlain, D.O.
|
| Vol #:
|
| 806
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
| C 1387
|
| W. Hill
|
| Vol #:
|
| 259
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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|
|
| C 9289
|
| E. Buck
|
| Vol #:
|
| 133
|
|
|
| C 9290
|
| E. Lundberg
|
| Vol #:
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| 133
|
|
|
| C 9291
|
| A. Janks
|
| Vol #:
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| 133
|
|
|
| C 9292
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| L. Krawitz
|
| Vol #:
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| 133
|
|
|
| C 9293
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| D. J. Wilson
|
| Vol #:
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| 133
|
|
|
| C 9294
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| S. Williams
|
| Vol #:
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| 133
|
|
|
| C 9295
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| S. Hassinger
|
| Vol #:
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| 133
|
|
|
| C 9296
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| P. C. Light
|
| Vol #:
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| 133
|
|
|
| C 9297
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| Mrs. K. Caine
|
| Vol #:
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| 133
|
|
|
| C 9298
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| C. Bruckner
|
| Vol #:
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| 133
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|
|
| C 9299
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| M. Kuntze
|
| Vol #:
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| 133
|
|
|
| C 9300
|
| K. Steincipher-Eberle, M.D.
|
| Vol #:
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| 133
|
|
|
| C 9301
|
| A. Matlock
|
| Vol #:
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| 133
|
|
|
| C 9302
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| J. Degabain
|
| Vol #:
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| 133
|
|
|
| C 9303
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| E. Garland
|
| Vol #:
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| 133
|
|
|
| C 9304
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| J. Degabain
|
| Vol #:
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| 133
|
|
|
| C 9305
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| M. Mattson
|
| Vol #:
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| 133
|
|
|
| C 9306
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| D. Bausano
|
| Vol #:
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| 133
|
|
|
| C 9307
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| D. Bausano
|
| Vol #:
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| 133
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|
|
| C 9308
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| G. Plamondon
|
| Vol #:
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| 133
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|
| | | | | | | |
|
|
| C 9309
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| S. E. Bender
|
| Vol #:
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| 133
|
|
|
| C 9310
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| D. Clair, M.D.
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| Vol #:
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| 133
|
|
|
| C 9311
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| M. Angle
|
| Vol #:
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| 133
|
|
|
| C 9312
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| S. Kirby
|
| Vol #:
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| 133
|
|
|
| C 9313
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| S. Dodd-Butters
|
| Vol #:
|
| 133
|
|
|
| C 9314
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| E. Meuth
|
| Vol #:
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| 133
|
|
|
| C 9315
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| E. Fedewa
|
| Vol #:
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| 133
|
|
|
| C 9316
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| M. Workman
|
| Vol #:
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| 133
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|
|
| C 9317
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| H. Vitullo
|
| Vol #:
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| 133
|
|
|
| C 9318
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| S. Sexton
|
| Vol #:
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| 133
|
|
|
| C 9319
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| C. Gonzalez
|
| Vol #:
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| 133
|
|
|
| C 9320
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| L. Harris
|
| Vol #:
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| 133
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|
|
| C 9321
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| A. Stanton
|
| Vol #:
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| 133
|
|
|
| C 9322
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| D. Pittman
|
| Vol #:
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| 133
|
|
|
| C 9323
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| R. Lara
|
| Vol #:
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| 133
|
|
|
| C 9324
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| R. Barkins
|
| Vol #:
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| 133
|
|
|
| C 9325
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| P. A. Grace
|
| Vol #:
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| 133
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|
|
| C 9326
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| M. Denham
|
| Vol #:
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| 133
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|
|
| C 9327
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| C. Hiatt
|
| Vol #:
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| 133
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|
|
| C 9328
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| M. Paltz
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| Vol #:
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| 133
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|
|
| C 9329
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| C. Swaim
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| Vol #:
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| 133
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|
|
| C 9330
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| M. E. Cairo
|
| Vol #:
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| 133
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|
|
| C 9331
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| K. Stewart
|
| Vol #:
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| 133
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|
|
| C 9332
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| J. Payne
|
| Vol #:
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| 133
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|
|
| C 9333
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| V. McKee
|
| Vol #:
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| 133
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|
|
| C 9334
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| D. Barrar
|
| Vol #:
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| 133
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|
|
| C 9335
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| D. Barrar
|
| Vol #:
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| 133
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|
|
| C 9336
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| M. Maks
|
| Vol #:
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| 133
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|
|
| C 9337
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| K. Hill
|
| Vol #:
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| 133
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|
|
| C 9338
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| K. Pearson-Bell
|
| Vol #:
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| 133
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|
|
| C 9339
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| I. French
|
| Vol #:
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| 133
|
|
|
| C 9340
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| D. Steele
|
| Vol #:
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| 133
|
|
|
| C 9341
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| C. P. Acker
|
| Vol #:
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| 133
|
|
|
| C 9342
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| V. M. Akin
|
| Vol #:
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| 133
|
|
|
| C 9343
|
| J. E. Sarin
|
| Vol #:
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| 133
|
|
|
| C 9344
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| G. Delon
|
| Vol #:
|
| 133
|
|
|
| C 9345
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| B. Caskey
|
| Vol #:
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| 133
|
|
| | | | | | | |
|
|
| C 9346
|
| R. A. Caitland
|
| Vol #:
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| 133
|
|
|
| C 9347
|
| J. M. Ambrose
|
| Vol #:
|
| 133
|
|
|
| C 9348
|
| J. Butler
|
| Vol #:
|
| 133
|
|
|
| C 9349
|
| C. Plaskett
|
| Vol #:
|
| 133
|
|
|
| C 9350
|
| T. Terry
|
| Vol #:
|
| 133
|
|
|
| C 9351
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| S. Korotkin
|
| Vol #:
|
| 133
|
|
|
| C 9352
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| J. Smith
|
| Vol #:
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| 133
|
|
|
| C 9353
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| J. K. Collins
|
| Vol #:
|
| 133
|
|
|
| C 9354
|
| R. Collins
|
| Vol #:
|
| 133
|
|
|
| C 9355
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| P. Ingram
|
| Vol #:
|
| 133
|
|
|
| C 9356
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| N. Stone
|
| Vol #:
|
| 133
|
|
|
| C 9357
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| E. Engler
|
| Vol #:
|
| 133
|
|
|
| C 9358
|
| H. Lorraine
|
| Vol #:
|
| 133
|
|
|
| C 9359
|
| M. Grundling
|
| Vol #:
|
| 133
|
|
|
| C 9360
|
| C. Brown
|
| Vol #:
|
| 133
|
|
|
| C 9361
|
| J. Craven
|
| Vol #:
|
| 133
|
|
|
| C 9362
|
| B. S. Oakes
|
| Vol #:
|
| 133
|
|
|
| C 9363
|
| A. Higgins
|
| Vol #:
|
| 133
|
|
|
| C 9364
|
| B. L. McCarrell
|
| Vol #:
|
| 133
|
|
|
| C 9365
|
| D. Kassell
|
| Vol #:
|
| 133
|
|
|
| C 9366
|
| C. Londerback
|
| Vol #:
|
| 133
|
|
|
| C 9367
|
| P. Paul
|
| Vol #:
|
| 133
|
|
|
| C 9368
|
| B. G. Miller
|
| Vol #:
|
| 133
|
|
|
| C 9369
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| A. McPhaul
|
| Vol #:
|
| 133
|
|
|
| C 9370
|
| P. Pickering
|
| Vol #:
|
| 133
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|
|
| C 9371
|
| S. Williams
|
| Vol #:
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| 133
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|
|
| C 9372
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| S. G. Crave
|
| Vol #:
|
| 133
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|
|
| C 9373
|
| R. J. Miller
|
| Vol #:
|
| 133
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|
|
| C 9374
|
| P. Wayne
|
| Vol #:
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| 133
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|
|
| C 9375
|
| P. J. Roth
|
| Vol #:
|
| 133
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|
|
| C 9376
|
| D. Meyers
|
| Vol #:
|
| 133
|
|
|
| C 9377
|
| C. Christian
|
| Vol #:
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| 133
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|
|
| C 9378
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| L. DeMasters
|
| Vol #:
|
| 133
|
|
|
| C 9379
|
| H. Donnelly
|
| Vol #:
|
| 133
|
|
|
| C 9380
|
| P. A. Dietor
|
| Vol #:
|
| 133
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|
|
| C 9381
|
| L. Hammond
|
| Vol #:
|
| 133
|
|
|
| C 9382
|
| D. Guiffredo
|
| Vol #:
|
| 133
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|
| | | | | | | |
|
|
| C 9383
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| L. D. Ames
|
| Vol #:
|
| 133
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|
|
| C 9384
|
| B. Agadoni
|
| Vol #:
|
| 133
|
|
|
| C 9385
|
| B. L. Peters Wilson
|
| Vol #:
|
| 133
|
|
|
| C 9386
|
| S. Peirce
|
| Vol #:
|
| 133
|
|
|
| C 9387
|
| E. Stumber
|
| Vol #:
|
| 133
|
|
|
| C 9388
|
| J. Boelzner
|
| Vol #:
|
| 133
|
|
|
| C 9389
|
| P. Wilch
|
| Vol #:
|
| 133
|
|
|
| C 9390
|
| V. Baiardi
|
| Vol #:
|
| 133
|
|
|
| C 9391
|
| S. Alt DO
|
| Vol #:
|
| 133
|
|
|
| C 9392
|
| C. Alerakhin
|
| Vol #:
|
| 133
|
|
|
| C 9393
|
| A. Gled
|
| Vol #:
|
| 133
|
|
|
| C 9394
|
| S. L. Harbor
|
| Vol #:
|
| 133
|
|
|
| C 9395
|
| D. Medwick
|
| Vol #:
|
| 133
|
|
|
| C 9396
|
| J. Freer
|
| Vol #:
|
| 133
|
|
|
| C 9397
|
| J. Terry
|
| Vol #:
|
| 133
|
|
|
| C 9398
|
| L. Huber
|
| Vol #:
|
| 133
|
|
|
| C 9399
|
| C. W. Wakes
|
| Vol #:
|
| 133
|
|
|
| C 9400
|
| P. Kmeellorth
|
| Vol #:
|
| 133
|
|
|
| C 9401
|
| illegible
|
| Vol #:
|
| 133
|
|
|
| C 9402
|
| M. L. Vazquez
|
| Vol #:
|
| 133
|
|
|
| EMC 1948
|
| S. Alongi
|
| Vol #:
|
| 123
|
|
|
| EMC 1949
|
| D. Bosco
|
| Vol #:
|
| 123
|
|
|
| EMC 1950
|
| R. Gaffin
|
| Vol #:
|
| 123
|
|
|
| EMC 1951
|
| A. Johnson
|
| Vol #:
|
| 123
|
|
|
| EMC 1952
|
| C. Fay
|
| Vol #:
|
| 123
|
|
|
| EMC 1953
|
| J. Mixon
|
| Vol #:
|
| 123
|
|
|
| EMC 1954
|
| Dr. G. Bernard
|
| Vol #:
|
| 123
|
|
|
| EMC 1955
|
| J. Somers
|
| Vol #:
|
| 123
|
|
|
| EMC 1956
|
| C. Koeksal
|
| Vol #:
|
| 123
|
|
|
| EMC 1957
|
| N. Newland
|
| Vol #:
|
| 123
|
|
|
| EMC 1958
|
| M. Mancinelli
|
| Vol #:
|
| 123
|
|
|
| EMC 1959
|
| T. Leder
|
| Vol #:
|
| 123
|
|
|
| EMC 1960
|
| M. Conrad
|
| Vol #:
|
| 123
|
|
|
| EMC 1961
|
| L. Frieders
|
| Vol #:
|
| 123
|
|
|
| EMC 1962
|
| A. Merkley
|
| Vol #:
|
| 123
|
|
|
| EMC 1963
|
| S. Schlipf
|
| Vol #:
|
| 123
|
|
|
| EMC 1964
|
| S. Schlipf
|
| Vol #:
|
| 123
|
|
| | | | | | | |
|
|
| EMC 1965
|
| C. Puopolo
|
| Vol #:
|
| 123
|
|
|
| EMC 1966
|
| J. Tarling
|
| Vol #:
|
| 123
|
|
|
| EMC 1967
|
| D. Abramschmitt
|
| Vol #:
|
| 123
|
|
|
| EMC 1968
|
| Dr. F. Franklin
|
| Vol #:
|
| 123
|
|
|
| EMC 1969
|
| D. Busichio
|
| Vol #:
|
| 123
|
|
|
| EMC 1970
|
| K. Morris
|
| Vol #:
|
| 123
|
|
|
| EMC 1971
|
| J. Henderson
|
| Vol #:
|
| 123
|
|
|
| EMC 1972
|
| P. Clymer
|
| Vol #:
|
| 123
|
|
|
| EMC 1973
|
| D. Reed
|
| Vol #:
|
| 123
|
|
|
| EMC 1974
|
| A. Kosch
|
| Vol #:
|
| 123
|
|
|
| EMC 1975
|
| M. Einsel
|
| Vol #:
|
| 123
|
|
|
| EMC 1976
|
| B. Sigman
|
| Vol #:
|
| 123
|
|
|
| EMC 1977
|
| J. Sumrall
|
| Vol #:
|
| 123
|
|
|
| EMC 1978
|
| B. Paape
|
| Vol #:
|
| 123
|
|
|
| EMC 1979
|
| J. Reinhart
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| EMC 1980
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| EMC 1981
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| B. Miller
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| M. McCarron, MSN, RNP
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| EMC 2019
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| EMC 2020
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| EMC 2021
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| EMC 2022
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| EMC 2023
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| EMC 2025
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| EMC 2026
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| EMC 2027
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| V. Olds
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| EMC 2028
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| M. Villegas
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| EMC 2029
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| C. Carri
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| EMC 2030
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| M. Riddle
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| EMC 2031
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| EMC 2032
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| EMC 2033
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| C. Ficarra
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| EMC 2034
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| S. Hagemann
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| EMC 2035
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| C. Cedarburg
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| EMC 2036
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| A. Picou
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| EMC 2037
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| Dr. Brown
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| EMC 2038
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| D. Erhard
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| EMC 2039
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| M. Branch
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| EMC 2040
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| B. Davis
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| EMC 2041
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| EMC 2042
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| K. Bery
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| EMC 2043
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| M. Karant
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| EMC 2044
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| EMC 2045
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| EMC 2046
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| A. Johnston
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| EMC 2047
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| EMC 2048
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| L. Phillips
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| EMC 2049
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| EMC 2050
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| G. Gregg
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| EMC 2051
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| M. Gregg
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| 123
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| EMC 2052
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| M. Citoli
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| 123
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| EMC 2053
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| K. Flaherty, J.D.
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| 123
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| EMC 2054
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| J. Sudbay
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| 123
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| EMC 2055
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| G. Jacobs
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| 123
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| EMC 2056
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| A. Stanton
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| 123
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| EMC 2057
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| L. Jones
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| 123
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| EMC 2058
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| K. Drew
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| 123
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| EMC 2059
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| L. Miles
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| 123
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| EMC 2060
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| E. Wright
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| 123
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| EMC 2061
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| J. Hatfield
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| 123
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| EMC 2062
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| A. Woody, RPh
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| 123
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|
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| EMC 2063
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| L. Mulkey
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| 123
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|
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| EMC 2064
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| S. King
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| 123
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|
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| EMC 2065
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| K. Santellan
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| 123
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| EMC 2066
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| L. Ortiz
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| 123
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|
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| EMC 2067
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| S. Barnard
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| 123
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|
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| EMC 2068
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| T. Orth
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| 123
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| EMC 2069
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| M. Hansen
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| 123
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|
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| EMC 2070
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| C. Osberg
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| 123
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|
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| EMC 2071
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| C. Small
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| 123
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|
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| EMC 2072
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| A. Sellers
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| 123
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| EMC 2073
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| M. Thurman
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| 123
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| EMC 2074
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| C. Edgett
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| EMC 2075
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| M. Cadle
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| EMC 2076
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| M. Webster
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| 123
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|
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| EMC 2077
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| P. Salzmann
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| Vol #:
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| 123
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|
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| EMC 2078
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| C. McCormick, R.N.
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| 123
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| EMC 2079
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| Dr. D. Woods
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| Vol #:
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| 123
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|
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| EMC 2080
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| M. Davison
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| 123
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|
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| EMC 2081
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| B. Harlingue
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| Vol #:
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| 123
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|
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| EMC 2082
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| C. Godwin
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| Vol #:
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| 123
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| EMC 2083
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| C. Hart
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| 123
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|
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| EMC 2084
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| B. Kennedy
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| Vol #:
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| 123
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|
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| EMC 2085
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| R. Cirino
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| 123
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|
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| EMC 2086
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| K. Newcomb
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| 123
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| EMC 2087
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| M. Wiley
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| Vol #:
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| 123
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|
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| EMC 2088
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| P. Steele
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| Vol #:
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| 123
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|
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| EMC 2089
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| M. Sickels
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| Vol #:
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| 123
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|
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| EMC 2090
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| S. Lambert
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| 123
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|
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| EMC 2091
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| J. Helgesen
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| 123
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|
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| EMC 2092
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| A. Mein
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| 123
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|
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| EMC 2093
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| C. Smith
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| Vol #:
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| 123
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|
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| EMC 2094
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| S. Kalil
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| 123
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|
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| EMC 2095
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| R. Wenrich
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| Vol #:
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| 123
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|
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| EMC 2096
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| S. Peterson
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| 123
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|
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| EMC 2097
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| S. Coughlin
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| Vol #:
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| 123
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|
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| EMC 2098
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| C. Brischetto
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| 123
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|
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| EMC 2099
|
| P. Sorensen
|
| Vol #:
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| 123
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|
|
| EMC 2100
|
| D. Thomas
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| Vol #:
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| 123
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|
|
| EMC 2101
|
| S. Frazier
|
| Vol #:
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| 123
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|
|
| EMC 2102
|
| B. Hicks
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| Vol #:
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| 123
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|
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| EMC 2103
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| P. Bynum
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| Vol #:
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| 123
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|
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| EMC 2104
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| M. Eppley
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| Vol #:
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| 123
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|
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| EMC 2105
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| D. Davis
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| Vol #:
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| 123
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|
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| EMC 2106
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| L. Landrum
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| Vol #:
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| 123
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|
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| EMC 2107
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| J. Markel
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| Vol #:
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| 123
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| EMC 2108
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| J. Eberth
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| 123
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|
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| EMC 2109
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| K. Wolfe
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| Vol #:
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| 123
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|
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| EMC 2110
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| D. Beck, ND
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| Vol #:
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| 123
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|
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| EMC 2111
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| D. Worden
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| 123
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| EMC 2112
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| J. Jordan
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| 123
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| EMC 2113
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| P. Anderson
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| Vol #:
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| 123
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|
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| EMC 2114
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| N. Avedon
|
| Vol #:
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| 123
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|
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| EMC 2115
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| B. Wynn
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| Vol #:
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| 123
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|
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| EMC 2116
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| P. Cleveland
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| Vol #:
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| 123
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| EMC 2117
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| E. Powell
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| Vol #:
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| 123
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|
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| EMC 2118
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| P. Colby
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| Vol #:
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| 123
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|
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| EMC 2119
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| D. Korcal
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| Vol #:
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| 123
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|
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| EMC 2120
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| C. Gilbrech
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| Vol #:
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| 123
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|
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| EMC 2121
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| A. Blackford
|
| Vol #:
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| 123
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|
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| EMC 2122
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| R. Robertson
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| Vol #:
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| 123
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|
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| EMC 2123
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| K. Dater
|
| Vol #:
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| 123
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|
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| EMC 2124
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| A. Lorraine
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| Vol #:
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| 123
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| EMC 2125
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| I. Jasper
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| Vol #:
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| 123
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|
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| EMC 2126
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| S. Morgan
|
| Vol #:
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| 123
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|
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| EMC 2127
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| G. Brooks
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| Vol #:
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| 123
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| EMC 2128
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| C. Curry
|
| Vol #:
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| 123
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|
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| EMC 2129
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| D. Simmons
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| Vol #:
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| 123
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| EMC 2130
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| J. Bean
|
| Vol #:
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| 123
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|
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| EMC 2131
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| S. Huschle
|
| Vol #:
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| 123
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|
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| EMC 2132
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| L. Kirby
|
| Vol #:
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| 123
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|
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| EMC 2133
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| M. Haley
|
| Vol #:
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| 123
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|
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| EMC 2134
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| R. Sponsel
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| Vol #:
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| 123
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|
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| EMC 2135
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| P. Jones
|
| Vol #:
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| 123
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|
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| EMC 2136
|
| Dr. T. Vance
|
| Vol #:
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| 123
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|
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| EMC 2137
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| P. Wilson
|
| Vol #:
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| 123
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|
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| EMC 2138
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| D. Goodson
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| Vol #:
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| 123
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|
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| EMC 2139
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| B. McGee
|
| Vol #:
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| 123
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|
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| EMC 2140
|
| S. Scruggs
|
| Vol #:
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| 123
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|
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| EMC 2141
|
| N. McCarvill
|
| Vol #:
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| 123
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|
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| EMC 2142
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| S. Ricci
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| Vol #:
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| 123
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| EMC 2143
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| D. Fetrow
|
| Vol #:
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| 123
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|
|
| EMC 2144
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| T. Hodel
|
| Vol #:
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| 123
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|
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| EMC 2145
|
| M. Kelly
|
| Vol #:
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| 123
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|
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| EMC 2146
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| G. Martino
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| Vol #:
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| 123
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|
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| EMC 2147
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| D. Fonte
|
| Vol #:
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| 123
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|
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| EMC 2148
|
| R. Scott
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| Vol #:
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| 123
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|
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| EMC 2149
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| D. Thalblum
|
| Vol #:
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| 123
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| | | | | | | |
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| EMC 2150
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| A. Sherman
|
| Vol #:
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| 123
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|
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| EMC 2151
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| A. Erwin
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| Vol #:
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| 123
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|
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| EMC 2152
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| C. Krallman
|
| Vol #:
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| 123
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|
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| EMC 2153
|
| Dr. F. Pranno
|
| Vol #:
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| 123
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|
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| EMC 2154
|
| C. Larouche
|
| Vol #:
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| 123
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|
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| EMC 2155
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| S. MacMillan
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| Vol #:
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| 123
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|
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| EMC 2156
|
| R. Steffen
|
| Vol #:
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| 123
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|
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| EMC 2157
|
| N. Chilkov
|
| Vol #:
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| 123
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|
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| EMC 2158
|
| N. Ruthenbeck
|
| Vol #:
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| 123
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|
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| EMC 2159
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| J. Pelzel
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| Vol #:
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| 123
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|
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| EMC 2160
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| D. Handel
|
| Vol #:
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| 123
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|
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| EMC 2161
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| S. Dickens
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| Vol #:
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| 123
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|
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| EMC 2162
|
| D. Dobbins
|
| Vol #:
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| 123
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|
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| EMC 2163
|
| R. Seedman, DVM
|
| Vol #:
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| 123
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|
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| EMC 2164
|
| J. Fenderbosch
|
| Vol #:
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| 123
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|
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| EMC 2165
|
| B. Hyda
|
| Vol #:
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| 123
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|
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| EMC 2166
|
| M. Young
|
| Vol #:
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| 123
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|
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| EMC 2167
|
| P. Myers
|
| Vol #:
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| 123
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|
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| EMC 2168
|
| C. Hall
|
| Vol #:
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| 123
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|
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| EMC 2169
|
| J. Todd
|
| Vol #:
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| 123
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|
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| EMC 2170
|
| Dr. S. Murphree
|
| Vol #:
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| 123
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|
|
| EMC 2171
|
| A. Hays
|
| Vol #:
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| 123
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|
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| EMC 2172
|
| J. Hays
|
| Vol #:
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| 123
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|
|
| EMC 2173
|
| C. Utter
|
| Vol #:
|
| 123
|
|
|
| EMC 2174
|
| L. Armer
|
| Vol #:
|
| 123
|
|
|
| EMC 2175
|
| D. Wills
|
| Vol #:
|
| 123
|
|
|
| EMC 2176
|
| C. McLeod
|
| Vol #:
|
| 123
|
|
|
| EMC 2177
|
| B. Albright
|
| Vol #:
|
| 123
|
|
|
| EMC 2178
|
| B. Curless
|
| Vol #:
|
| 123
|
|
|
| EMC 2179
|
| J. Bliss
|
| Vol #:
|
| 123
|
|
|
| EMC 2180
|
| J. Reese
|
| Vol #:
|
| 123
|
|
|
| EMC 2181
|
| K. Bryan
|
| Vol #:
|
| 123
|
|
|
| EMC 2182
|
| C. Maggiore
|
| Vol #:
|
| 123
|
|
|
| EMC 2183
|
| M. Collins
|
| Vol #:
|
| 123
|
|
|
| EMC 2184
|
| L. Brown
|
| Vol #:
|
| 123
|
|
|
| EMC 2185
|
| C. Carr
|
| Vol #:
|
| 123
|
|
|
| EMC 2186
|
| J. Goulart
|
| Vol #:
|
| 123
|
|
| | | | | | | | |
|
|
| EMC 2187
|
| C. Peterson
|
| Vol #:
|
| 123
|
|
|
| EMC 2188
|
| J. Sammons
|
| Vol #:
|
| 123
|
|
|
| EMC 2189
|
| J. Abel
|
| Vol #:
|
| 123
|
|
|
| EMC 2190
|
| D. Pantalion
|
| Vol #:
|
| 123
|
|
|
| EMC 2191
|
| H. James
|
| Vol #:
|
| 123
|
|
|
| EMC 2192
|
| R. Lively
|
| Vol #:
|
| 123
|
|
|
| 2006E-0206
|
| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
|
|
|
| APP 1
|
| Medtronic Vascular
|
| Vol #:
|
| 1
|
|
|
| LET 1
|
| U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| LET 2
|
| U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2006N-0181
|
| Product Stability Data: Notice of Pilot Project
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2006P-0090
|
| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
|
|
|
| SUP 1
|
| Xanodyne Pharmaceuticals, Inc. (Xanodyne)
|
| Vol #:
|
| 2
|
|
|
| 2006P-0205
|
| Require Vitamin D be added to cereal-grain products
|
|
|
| ACK 1
|
| FDA/DDM to Rutgers, The State University Of New Jersey
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Rutgers, The State University Of New Jersey
|
| Vol #:
|
| 1
|
|
|
| 2006P-0207
|
| ANDA Suitability for Cetirizine Hydrochloride Soft Gelatin Capsules 5mg and 10mg
|
|
|
| ACK 1
|
| FDA/DDM to Strides Inc.
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Strides Inc.
|
| Vol #:
|
| 1
|
|
|
| 2006P-0208
|
| Permit the filing of an ANDA for Loratadine Soft Gelatin Capsules 10mg
|
|
|
| ACK 1
|
| FDA/DDM to Strides, Inc.
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| FDA/DDM to Strides, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2006P-0209
|
| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
|
|
|
| ACK 1
|
| FDA/DDMB to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|