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| Dockets Entered
On March 8, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 2002P-0243
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| Require Issuance of Medication Guide for All Statin Drugs
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| 2002P-0244
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| Warning Statement for All HMG Co-A Reductase Inhibitors
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| 2004P-0379
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| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2005P-0096
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| ANDA 77-421 Loratadine Syrup- Hives relief
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| C
11
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| Rollins School of Public Health (Emory University)
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| Vol #:
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| 142
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| 2002P-0243
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| Require Issuance of Medication Guide for All Statin Drugs
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| PDN
1
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| HFD-001 to Emord & Associates
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| Vol #:
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| 4
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| 2002P-0244
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| Warning Statement for All HMG Co-A Reductase Inhibitors
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| PDN
1
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| HFD-001 to Emord & Associates
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| Vol #:
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| 4
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| RBF
2
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| Korangy Radiology Associates, et al
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| Vol #:
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| 8
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| C 49
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| Form Letter count 19
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| Vol #:
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| 21
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| C 50
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| J Connerton
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| Vol #:
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| 15
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| C 51
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| M Trevey
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| Vol #:
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| 15
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| C 52
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| S Weaver + 8 signatures
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| Vol #:
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| 15
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| C 53
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| S Orans + 19 signatures
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| Vol #:
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| 15
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| C 54
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| D Driscoll + 22 signatures
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| Vol #:
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| 15
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| C
55
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| Monsanto Company
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| Vol #:
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| 15
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| C 56
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| P Burchard
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| Vol #:
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| 15
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| C 57
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| C Nelson
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| Vol #:
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| 15
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| C 58
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| K Edwards
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| Vol #:
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| 15
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| C 59
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| M Cruz
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| Vol #:
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| 15
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| C 60
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| R Coriell
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| Vol #:
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| 15
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| C
61
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 15
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|
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| C 62
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| L Lewis
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| Vol #:
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| 15
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| C 63
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| S Flynn
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| Vol #:
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| 15
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| C 64
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| Dr I S Perligieri
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| Vol #:
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| 15
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| | | | | | | |
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| C 65
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| S Unze
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| Vol #:
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| 15
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| C 66
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| P Kup
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| Vol #:
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| 15
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| C
67
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| National Food Processors Association (NFPA)
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| Vol #:
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| 15
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|
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| C 68
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| D Penders
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| Vol #:
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| 15
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| C 69
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| P Jain
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| Vol #:
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| 15
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| C 70
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| V Hershey
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| Vol #:
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| 15
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| C 71
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| N Rice
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| Vol #:
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| 15
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| C 72
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| R Lang
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| Vol #:
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| 15
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| C 73
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| M Brelje
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| Vol #:
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| 15
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| C
74
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| Biotechnology Industry Organization
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| Vol #:
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| 15
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| C 75
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| E Strauss
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| Vol #:
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| 15
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| C 76
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| R Hornsby
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| Vol #:
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| 15
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| CR 1
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| Center for Food Safety
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| Vol #:
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| 15
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|
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| EMC 1370
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| M Tucker
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| Vol #:
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| 18
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| EMC
1371
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| Living Resources Company
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| Vol #:
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| 18
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| EMC
1372
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| National Campaign for Sustainable Agriculture
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| Vol #:
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| 18
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|
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| EMC
1373
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| National Campaign for Sustainable Agriculture
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| Vol #:
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| 18
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|
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| EMC 1374
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| T Raymondson
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| Vol #:
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| 19
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| EMC 1375
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| P Matheson
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| Vol #:
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| 18
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| EMC
1376
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| Organic Trade Association
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| Vol #:
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| 18
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|
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| EMC 1377
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| B Avery
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| Vol #:
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| 18
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| EMC 1378
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| C Heath
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| Vol #:
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| 18
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|
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| EMC 1379
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| V Wong
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| Vol #:
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| 18
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|
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| EMC 1380
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| S Trexler
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| Vol #:
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| 18
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| EMC 1381
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| K Wiseman
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| Vol #:
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| 18
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| EMC 1382
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| D Chamagme
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| Vol #:
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| 18
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|
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| EMC
1383
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| University of California, Davis
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| Vol #:
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| 18
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|
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| EMC 1384
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| K Putney
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| Vol #:
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| 18
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| EMC 1385
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| G Shaver
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| Vol #:
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| 18
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|
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| EMC 1386
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| J Fuller
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| Vol #:
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| 18
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| EMC
1387
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| University of California, Davis
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| Vol #:
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| 18
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|
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| EMC 1388
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| M Schonbeck PhD
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| Vol #:
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| 18
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|
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| EMC 1389
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| M Frago
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| Vol #:
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| 18
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|
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| EMC
1390
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| Community Alliance with Family Farmers (CAFF)
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| Vol #:
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| 18
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|
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| EMC 1391
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| K Kauffman
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| Vol #:
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| 18
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|
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| EMC
1392
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| University of California, Davis
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| Vol #:
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| 18
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| EMC 1393
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| R Boettcher
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| Vol #:
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| 18
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| | | | | | | |
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| EMC 1394
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| C Blair
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| Vol #:
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| 18
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| EMC 1395
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| L Marselle
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| Vol #:
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| 18
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| EMC
1396
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| National Plains Sustainable Agriculture Society
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| Vol #:
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| 18
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|
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| EMC
1397
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| University California, Davis
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| Vol #:
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| 18
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|
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| EMC 1398
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| D Metivier
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| Vol #:
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| 18
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|
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| EMC 1399
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| J Geis
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| Vol #:
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| 18
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| EMC 1400
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| C Whalen
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| Vol #:
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| 18
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|
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| EMC 1401
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| W Manuel
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| Vol #:
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| 22
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| EMC
1402
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| Beyond Pesticides
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| Vol #:
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| 22
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|
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| EMC 1403
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| R Roxas
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| Vol #:
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| 22
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|
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| EMC 1404
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| L MacKinder
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| Vol #:
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| 22
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|
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| EMC 1405
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| G Bachman
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| Vol #:
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| 22
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|
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| EMC 1406
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| C Jones
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| Vol #:
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| 22
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|
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| EMC
1407
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| Center for Food Safety
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| Vol #:
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| 22
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|
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| EMC 1408
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| K Steinmann
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| Vol #:
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| 22
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|
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| EMC 1409
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| R Vogt
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| Vol #:
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| 22
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|
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| EMC 1410
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| N Miller
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| Vol #:
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| 22
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| EMC 1411
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| K Stumpf
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| Vol #:
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| 22
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|
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| EMC 1412
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| H Kyle
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| Vol #:
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| 22
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| EMC 1413
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| R King
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| Vol #:
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| 22
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| EMC 1414
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| L Clark
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| Vol #:
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| 22
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|
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| EMC 1415
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| P Wilson
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| Vol #:
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| 22
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| EMC 1416
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| J Brickner
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| Vol #:
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| 22
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|
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| EMC 1417
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| T Garner
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| Vol #:
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| 22
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|
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| EMC 1418
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| R Reynolds
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| Vol #:
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| 22
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| EMC 1419
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| S Paltin MD
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| Vol #:
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| 22
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|
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| EMC 1420
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| S Wingrove
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| Vol #:
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| 22
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|
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| EMC 1421
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| S Osborne
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| Vol #:
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| 22
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| EMC 1422
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| M Russell
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| Vol #:
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| 22
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| EMC 1423
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| C Sedotto
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| Vol #:
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| 22
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| EMC 1424
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| C Pettey
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| Vol #:
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| 22
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|
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| EMC 1425
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| J Lefevre
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| Vol #:
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| 22
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|
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| EMC 1426
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| P Callan
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| Vol #:
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| 22
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|
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| EMC 1427
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| C Lizarraga
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| Vol #:
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| 22
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|
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| EMC 1428
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| D Gersetnfeld
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| Vol #:
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| 22
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|
|
| EMC 1429
|
| R Gersetnfeld
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| Vol #:
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| 22
|
|
|
| EMC 1430
|
| K Stanley
|
| Vol #:
|
| 22
|
|
| | | | | | | | |
|
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| EMC 1431
|
| L Calisti
|
| Vol #:
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| 22
|
|
|
| 2004N-0230
|
| Food; Current Good Manufacturing Practice Regulations; Public Meetings
|
|
|
| C 12
|
| H. Rubin
|
| Vol #:
|
| 5
|
|
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| C 13
|
| J. Meagher
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| Vol #:
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| 5
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|
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| C 14
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| A. Meade
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| Vol #:
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| 5
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|
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| C 15
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| S. Rapp
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| Vol #:
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| 5
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|
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| C 16
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| L. Hennessey, MD
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| Vol #:
|
| 5
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|
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| C 17
|
| Mrs Thompson
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| Vol #:
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| 5
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|
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| C 18
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| S. Bernal
|
| Vol #:
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| 5
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|
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| C 19
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| I. Fitzgerald
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| Vol #:
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| 5
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|
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| C 20
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| S. Chhabra, PhD
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| Vol #:
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| 5
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|
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| C 21
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| M. Lassen
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| Vol #:
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| 5
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|
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| C
22
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| Allergy and Asthma Associates of Pittsburgh
|
| Vol #:
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| 5
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|
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| C 23
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| J and J Holmstrom
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| Vol #:
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| 5
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|
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| C 24
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| R. Schoenauer
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| Vol #:
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| 5
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|
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| C 25
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| S , D and N Heise
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| Vol #:
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| 5
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|
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| C 26
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| K. Quinones
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| Vol #:
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| 5
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|
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| C 27
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| R. Voss
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| Vol #:
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| 5
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|
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| C 28
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| W. Voss
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| Vol #:
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| 5
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|
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| C 29
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| G. Spatacco
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| Vol #:
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| 5
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|
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| C 30
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| G. Spatacco
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| Vol #:
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| 5
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|
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| C 31
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| G. Spatacco
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| Vol #:
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| 5
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|
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| C 32
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| M. Hodgeman, Esq
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| Vol #:
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| 5
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|
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| C 33
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| M. Hodgeman, Esq
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| Vol #:
|
| 5
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|
|
| C 34
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| M. Hodgeman, Esq
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| Vol #:
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| 5
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|
|
| C 35
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| M. Hodgeman, Esq
|
| Vol #:
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| 5
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|
|
| C 36
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| A. Lawson
|
| Vol #:
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| 5
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|
|
| C 37
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| E. Nourian
|
| Vol #:
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| 5
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|
|
| C 38
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| L. Blitzer
|
| Vol #:
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| 5
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|
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| C 39
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| E. Pennington
|
| Vol #:
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| 5
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|
|
| C 40
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| M. Starr
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| Vol #:
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| 5
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|
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| C 41
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| L. Rich
|
| Vol #:
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| 5
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|
|
| C 42
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| L. Botwinick
|
| Vol #:
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| 5
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|
|
| C 43
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| N. Rosen
|
| Vol #:
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| 5
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|
|
| C 44
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| B Baker and Dr. R. Korenberg
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| Vol #:
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| 5
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|
|
| C 45
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| S. Rosenzweig
|
| Vol #:
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| 5
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|
| | | | | | | |
|
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| C 46
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| Mr and Mrs T.W. Neville
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| Vol #:
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| 5
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|
|
| C 47
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| Dr and Mrs D. Wysong
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| Vol #:
|
| 5
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|
|
| C 48
|
| R and S Nash
|
| Vol #:
|
| 5
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|
|
| C 49
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| Dr. M. Ziboh, MD
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| Vol #:
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| 5
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|
|
| C 50
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| E. Wysong
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| Vol #:
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| 5
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|
|
| C 51
|
| T. Bragg
|
| Vol #:
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| 5
|
|
|
| C 52
|
| R. Martin
|
| Vol #:
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| 5
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|
|
| C 53
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| J. Aplin
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| Vol #:
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| 5
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|
|
| C 54
|
| S and J Larkin
|
| Vol #:
|
| 5
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|
|
| C 55
|
| T. Walker
|
| Vol #:
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| 5
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|
|
| C 56
|
| J. Hendryx
|
| Vol #:
|
| 5
|
|
|
| C 57
|
| P. Upton
|
| Vol #:
|
| 5
|
|
|
| C 58
|
| G. Vaughan
|
| Vol #:
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| 5
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|
|
| C 59
|
| G. Walker
|
| Vol #:
|
| 5
|
|
|
| C 60
|
| M. Kaminski
|
| Vol #:
|
| 5
|
|
|
| C 61
|
| E. Brown
|
| Vol #:
|
| 5
|
|
|
| C 62
|
| H and S Brown
|
| Vol #:
|
| 5
|
|
|
| C 63
|
| D. Barratt
|
| Vol #:
|
| 5
|
|
|
| C 64
|
| D. Barratt
|
| Vol #:
|
| 5
|
|
|
| C 65
|
| A. Docal
|
| Vol #:
|
| 5
|
|
|
| C 66
|
| W. Boye
|
| Vol #:
|
| 5
|
|
|
| C
67
|
| Arkansas Allergy & Asthma Clinic, PA
|
| Vol #:
|
| 5
|
|
|
| C
68
|
| Arkansas Allergy & Asthma Clinic, PA
|
| Vol #:
|
| 5
|
|
|
| C 69
|
| Mr and Mrs J and V Mangano
|
| Vol #:
|
| 5
|
|
|
| C 70
|
| S and C Paulson
|
| Vol #:
|
| 5
|
|
|
| C 71
|
| L. Weinhardt
|
| Vol #:
|
| 5
|
|
|
| C 72
|
| S. DeLay
|
| Vol #:
|
| 5
|
|
|
| C
73
|
| Arkansas Allergy & Asthma Clinic, PA
|
| Vol #:
|
| 5
|
|
|
| C 74
|
| K. Kauke
|
| Vol #:
|
| 5
|
|
|
| C 75
|
| R. Arndt
|
| Vol #:
|
| 5
|
|
|
| C 76
|
| T. DeMann
|
| Vol #:
|
| 5
|
|
|
| C 77
|
| A. Martinez
|
| Vol #:
|
| 5
|
|
|
| C 78
|
| R. Gilbert
|
| Vol #:
|
| 5
|
|
|
| C 79
|
| A. Aernouts
|
| Vol #:
|
| 5
|
|
|
| C 80
|
| A. Bhai
|
| Vol #:
|
| 5
|
|
|
| C 81
|
| L. Blumsack
|
| Vol #:
|
| 5
|
|
|
| C 82
|
| L. Walsh
|
| Vol #:
|
| 5
|
|
| | | | | | | |
|
|
| C 83
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| Mr and Mrs P and M Modica
|
| Vol #:
|
| 5
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|
|
| C 84
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| Mr and Mrs C and T Coll
|
| Vol #:
|
| 5
|
|
|
| C 85
|
| Mr and Mrs J and M Gilbride
|
| Vol #:
|
| 5
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|
|
| C 86
|
| B. Gorab
|
| Vol #:
|
| 5
|
|
|
| C 87
|
| W. Bowman
|
| Vol #:
|
| 5
|
|
|
| C 88
|
| A. Meyers
|
| Vol #:
|
| 5
|
|
|
| C 89
|
| J. Meyers
|
| Vol #:
|
| 5
|
|
|
| C 90
|
| P. Himeles
|
| Vol #:
|
| 5
|
|
|
| C 91
|
| V. Welisch
|
| Vol #:
|
| 5
|
|
|
| C 92
|
| R. Martikainen
|
| Vol #:
|
| 5
|
|
|
| C 93
|
| R. Brown
|
| Vol #:
|
| 5
|
|
|
| C 94
|
| Boos Family
|
| Vol #:
|
| 5
|
|
|
| C 95
|
| L. Aronsky
|
| Vol #:
|
| 5
|
|
|
| C 96
|
| A. Parker
|
| Vol #:
|
| 5
|
|
|
| C 97
|
| R. Wallstrom, MD
|
| Vol #:
|
| 5
|
|
|
| C 98
|
| D. Hoppe
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| Vol #:
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| 5
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|
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| C 99
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| M. Bosselman
|
| Vol #:
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| 5
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|
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| C 100
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| R and K Chutter
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| Vol #:
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| 5
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|
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| C 101
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| K. Dix
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| Vol #:
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| 6
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|
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| C 102
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| N. Larenzo
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| Vol #:
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| 6
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|
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| C 103
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| D and S Faragher
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| Vol #:
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| 6
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|
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| C 104
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| B. Wallace
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| Vol #:
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| 6
|
|
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| C 105
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| B and F Davis
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| Vol #:
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| 6
|
|
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| C 106
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| J. Glasser, MD
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| Vol #:
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| 6
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|
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| C 107
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| D. Kent
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| Vol #:
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| 6
|
|
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| C 108
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| P. Schwartz
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| Vol #:
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| 6
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|
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| C 109
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| P. Schwartz
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| Vol #:
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| 6
|
|
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| C 110
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| H. Fenster
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| Vol #:
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| 6
|
|
|
| C 111
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| K. Walker, MD
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| Vol #:
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| 6
|
|
|
| C 112
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| M. Szmansky
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| Vol #:
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| 6
|
|
|
| C
113
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| Arkansas Allergy & asthma Clinic, PA
|
| Vol #:
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| 6
|
|
|
| C 114
|
| J. Goossen
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| Vol #:
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| 6
|
|
|
| C 115
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| E. Fogerty
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| Vol #:
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| 6
|
|
|
| C 116
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| M. Schaap
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| Vol #:
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| 6
|
|
|
| C 117
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| Dr and Mrs A Hucek
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| Vol #:
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| 6
|
|
|
| C 118
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| L and R Crocetti
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| Vol #:
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| 6
|
|
|
| C 119
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| K. Szafranski
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| Vol #:
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| 6
|
|
| | | | | | | |
|
|
| C 120
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| C. Hall
|
| Vol #:
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| 6
|
|
|
| C 121
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| S. Farris
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| Vol #:
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| 6
|
|
|
| C 122
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| D. Warick
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| Vol #:
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| 6
|
|
|
| C 123
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| L. Kozak
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| Vol #:
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| 6
|
|
|
| C 124
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| T. Waters
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| Vol #:
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| 6
|
|
|
| C 125
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| A. Furlong
|
| Vol #:
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| 6
|
|
|
| C 126
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| B. Hella
|
| Vol #:
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| 6
|
|
|
| C 127
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| B Foster
|
| Vol #:
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| 6
|
|
|
| C 128
|
| A and J Kosieradzki
|
| Vol #:
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| 6
|
|
|
| C 129
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| P. Callaghan
|
| Vol #:
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| 6
|
|
|
| C 130
|
| N. Vaughan
|
| Vol #:
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| 6
|
|
|
| C 131
|
| J. Alt
|
| Vol #:
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| 6
|
|
|
| C 132
|
| C. Baiocco
|
| Vol #:
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| 6
|
|
|
| C 133
|
| J. Fabisiak
|
| Vol #:
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| 6
|
|
|
| C 134
|
| L. Slama
|
| Vol #:
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| 6
|
|
|
| C 135
|
| J. Miller
|
| Vol #:
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| 6
|
|
|
| C 136
|
| A. Hojnacke
|
| Vol #:
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| 6
|
|
|
| C 137
|
| H. Nowlin
|
| Vol #:
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| 6
|
|
|
| C
138
|
| University of Pittsburgh
|
| Vol #:
|
| 6
|
|
|
| C 139
|
| C. Hunt
|
| Vol #:
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| 6
|
|
|
| C 140
|
| E. Bank
|
| Vol #:
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| 6
|
|
|
| C 141
|
| K. Voulalas,MS,RD,LD,CNSD
|
| Vol #:
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| 6
|
|
|
| C 142
|
| B. Kelly
|
| Vol #:
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| 6
|
|
|
| C 143
|
| J. Curran
|
| Vol #:
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| 6
|
|
|
| C 144
|
| E. Twombly
|
| Vol #:
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| 6
|
|
|
| C 145
|
| C. Starks
|
| Vol #:
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| 6
|
|
|
| C 146
|
| M. Bernal
|
| Vol #:
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| 6
|
|
|
| C 147
|
| H and T Schmitt
|
| Vol #:
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| 6
|
|
|
| C 148
|
| R. Hodgeman
|
| Vol #:
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| 6
|
|
|
| C 149
|
| R. Hodgeman
|
| Vol #:
|
| 6
|
|
|
| C 150
|
| R. Hodgeman
|
| Vol #:
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| 6
|
|
|
| C 151
|
| E. Mills
|
| Vol #:
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| 6
|
|
|
| C 152
|
| N. Streiter
|
| Vol #:
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| 6
|
|
|
| C 153
|
| T. Hirsch
|
| Vol #:
|
| 6
|
|
|
| C 154
|
| A. Porter
|
| Vol #:
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| 6
|
|
|
| C 155
|
| T. Kemper
|
| Vol #:
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| 6
|
|
|
| C 156
|
| E. Metayer
|
| Vol #:
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| 6
|
|
| | | | | | | |
|
|
| C 157
|
| A. Tascone
|
| Vol #:
|
| 6
|
|
|
| C 158
|
| H. Cochran
|
| Vol #:
|
| 6
|
|
|
| C 159
|
| E. Recker
|
| Vol #:
|
| 6
|
|
|
| C 160
|
| K. Perkins
|
| Vol #:
|
| 6
|
|
|
| C 161
|
| M. Briggs
|
| Vol #:
|
| 6
|
|
|
| C 162
|
| M and C Braun
|
| Vol #:
|
| 6
|
|
|
| C 163
|
| D. Ryan
|
| Vol #:
|
| 6
|
|
|
| C 164
|
| T. Thompson
|
| Vol #:
|
| 6
|
|
|
| C 165
|
| G. Velsmid
|
| Vol #:
|
| 6
|
|
|
| C 166
|
| R. Levin
|
| Vol #:
|
| 6
|
|
|
| C 167
|
| R. Brandt
|
| Vol #:
|
| 6
|
|
|
| C 168
|
| E. Barratt
|
| Vol #:
|
| 6
|
|
|
| C 169
|
| S and P Nash
|
| Vol #:
|
| 6
|
|
|
| C 170
|
| M. Thompson
|
| Vol #:
|
| 6
|
|
|
| C 171
|
| K. Jones
|
| Vol #:
|
| 6
|
|
|
| C 172
|
| M and D Lewis
|
| Vol #:
|
| 6
|
|
|
| C 173
|
| D and S Behrendt
|
| Vol #:
|
| 6
|
|
|
| C 174
|
| R. McDonald
|
| Vol #:
|
| 6
|
|
|
| C 175
|
| E. DeSantis
|
| Vol #:
|
| 6
|
|
|
| C 176
|
| C and M Fountain
|
| Vol #:
|
| 6
|
|
|
| C 177
|
| A. Freeland
|
| Vol #:
|
| 6
|
|
|
| C 178
|
| V. Lacher
|
| Vol #:
|
| 6
|
|
|
| C 179
|
| J. Wiaz
|
| Vol #:
|
| 6
|
|
|
| C 180
|
| H and P Armstrong
|
| Vol #:
|
| 6
|
|
|
| C 181
|
| M and L Berg
|
| Vol #:
|
| 6
|
|
|
| C 182
|
| J. Blaes
|
| Vol #:
|
| 6
|
|
|
| C 183
|
| B. Spellacy
|
| Vol #:
|
| 6
|
|
|
| C 184
|
| L and C Carson
|
| Vol #:
|
| 6
|
|
|
| C 185
|
| D. Gerould
|
| Vol #:
|
| 6
|
|
|
| C 186
|
| J and P Black
|
| Vol #:
|
| 6
|
|
|
| C 187
|
| H and L Moses
|
| Vol #:
|
| 6
|
|
|
| C 188
|
| J. Chomicki
|
| Vol #:
|
| 6
|
|
|
| C 189
|
| K Hudspeth
|
| Vol #:
|
| 6
|
|
|
| C 190
|
| D. Stiver
|
| Vol #:
|
| 6
|
|
|
| C 191
|
| S. Markson
|
| Vol #:
|
| 6
|
|
|
| C
192
|
| Ear, Nose & Throat Associates of Springfield, Inc.
|
| Vol #:
|
| 6
|
|
|
| C
193
|
| Children's Hospital of Philadelphia
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
|
| 2004P-0379
|
| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
|
|
|
| LET
1
|
| HFD-005 to AAC Consulting Group
|
| Vol #:
|
| 1
|
|
|
| 2005P-0096
|
| ANDA 77-421 Loratadine Syrup- Hives relief
|
|
|
| ACK
1
|
| HFA-305 to Silarx Pharmaceuticals, Inc
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| Silarx Pharmaceuticals, Inc
|
| Vol #:
|
| 1
|
|
|