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| Dockets Entered
On January 18, 2007
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| Docket #
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| Title
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| 1986V-0315
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| Ion laser technology series ILT 5000 Demo unit
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2005P-0496
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| ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
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| 2005V-0009
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| Projector for a Laser Light Show
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006D-0514
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| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
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| 2006P-0007
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| Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
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| 2006P-0173
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| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
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| 2006P-0285
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| Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale
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| 2006P-0287
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| determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2006P-0311
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| Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0442
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
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| 2006P-0487
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| Health Claim Petition: Isomaltulose and Dental Caries
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| 2007P-0028
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| Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons
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| 1986V-0315
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| Ion laser technology series ILT 5000 Demo unit
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| EXP 4
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| California Technical Associates dba CTA Systems
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| Vol #:
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| 1
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 56
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| No signature
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| Vol #:
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| 9
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| C 57
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| Illigible
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| Vol #:
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| 9
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| C 58
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| R. Muncrief
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| Vol #:
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| 9
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| C 59
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| B. Briswell
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| Vol #:
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| 9
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| C 60
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| M. Crotty
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| Vol #:
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| 9
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| C 61
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| J. Coryea
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| Vol #:
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| 9
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| C 62
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| J and S May
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| Vol #:
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| 9
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| C 63
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| A. Casanova
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| Vol #:
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| 9
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| C 64
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| B. Merryweather
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| Vol #:
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| 9
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| C 65
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| E. Levin
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| Vol #:
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| 9
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| C 66
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| S. Younger
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| Vol #:
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| 9
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| C 67
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| E. Schailile
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| Vol #:
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| 9
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| C 68
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| G. Weining
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| Vol #:
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| 9
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| C 69
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| No signature
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| Vol #:
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| 9
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| C 70
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| A. Skowronek
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| Vol #:
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| 9
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| C 71
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| G. Roth
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| Vol #:
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| 9
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| C 72
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| H. Vessell
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| Vol #:
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| 9
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| C 73
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| J. Whitehead
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| Vol #:
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| 9
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| C 74
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| B. Seely
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| Vol #:
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| 9
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| C 75
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| H. Weatherford
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| Vol #:
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| 9
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| C 76
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| V. Bequette
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| Vol #:
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| 9
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| C 77
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| S. Waters
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| Vol #:
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| 9
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| C 78
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| S. Waters
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| Vol #:
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| 9
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| C 79
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| S. Waters
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| Vol #:
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| 9
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| C 80
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| J. Hairston
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| Vol #:
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| 9
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| C 15
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| Children's Memorial Hospital
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| Vol #:
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| 3
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| C 16
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| Florida Center for Cellular Therapy
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| Vol #:
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| 3
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| C 17
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| E. Agura, M.D.
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| Vol #:
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| 3
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| C 18
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| University of Florida
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| Vol #:
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| 3
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| C 19
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| Stanford University
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| Vol #:
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| 3
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| C 20
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| Duke University Medical Center
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| Vol #:
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| 3
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| C 21
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| HollisterStier Laboratories, LLC
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| Vol #:
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| 3
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| C 22
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| Allergy Laboratories, Inc.
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| Vol #:
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| 3
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| 2005P-0496
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| ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
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| PAV 1
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| FDA/CDER to Mayne Pharma (USA) Inc.
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| Vol #:
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| 2
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| 2005V-0009
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| Projector for a Laser Light Show
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| EXP 1
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| Laser Show Parties
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| Vol #:
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| 1
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| C 1084
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| R. Hopklins
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| Vol #:
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| 40
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| C 1085
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| T. McCourt
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| Vol #:
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| 40
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| C 1086
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| J and M Miller
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| Vol #:
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| 40
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| C 1087
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| R. Shay
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| Vol #:
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| 40
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| C 1088
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| N. LaGuda
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| Vol #:
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| 40
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| C 1089
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| B. Dolph
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| Vol #:
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| 40
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| C 1090
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| J. Jalbert
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| Vol #:
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| 40
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| C 1091
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| F and K Riedel
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| Vol #:
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| 40
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| C 1092
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| J. Sherman
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| Vol #:
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| 40
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| C 1093
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| J. Casey
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| Vol #:
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| 40
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| C 1094
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| M. Callahan
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| Vol #:
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| 40
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| C 1095
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| M and M Sabine
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| Vol #:
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| 40
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| C 1096
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| M and T Kachris
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| Vol #:
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| 40
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| C 1097
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| Dr. T. Hogan
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| Vol #:
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| 40
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| C 1098
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| J. Lairs
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| Vol #:
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| 40
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| C 1099
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| P. Henry
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| Vol #:
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| 40
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| C 1100
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| J Klein et al.
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| Vol #:
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| 40
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| C 1101
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| J and C Ely
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| Vol #:
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| 40
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| C 1102
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| C. Tonkinson
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| Vol #:
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| 40
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| C 1103
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| J. Ellingson
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| Vol #:
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| 40
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| C 1104
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| I. Tedesco et al
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| Vol #:
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| 40
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| C 1105
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| G. McDonald
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| Vol #:
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| 40
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| C 1106
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| K. Porter
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| Vol #:
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| 41
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| C 1107
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| S. Pawelski
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| Vol #:
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| 41
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| C 1108
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| J. Cizek
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| Vol #:
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| 41
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| C 1109
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| D. Brown
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| Vol #:
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| 41
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| C 1110
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| M and S Allard
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| Vol #:
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| 41
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| C 1111
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| C. Brown
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| Vol #:
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| 41
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| C 1112
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| A. Ostrowski
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| Vol #:
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| 41
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| C 1113
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| J. Hitzelberger
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| Vol #:
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| 41
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| C 1114
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| A. Bizub
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| Vol #:
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| 41
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| C 1115
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| J. Epkey
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| Vol #:
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| 41
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| C 1116
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| J. Farmer
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| Vol #:
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| 41
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| C 1117
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| J. Fields
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| Vol #:
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| 41
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| C 1118
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| J. Fiacco
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| Vol #:
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| 41
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| C 1119
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| G. Lallement
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| Vol #:
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| 41
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| C 1120
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| D. Schuster
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| Vol #:
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| 41
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| C 1121
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| M and D Ernst
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| Vol #:
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| 41
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| C 1122
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| J. Guillette
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| Vol #:
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| 41
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| C 1123
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| J and M Miller
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| Vol #:
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| 41
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| C 1124
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| F. Seiker
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| Vol #:
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| 41
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| C 1125
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| D. Keefe, S.J., J.D., S.T.D.
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| Vol #:
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| 41
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| C 1126
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| D. Paige
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| Vol #:
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| 41
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| C 1127
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| J. McDonsoy
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| Vol #:
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| 41
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| C 1128
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| K. Steger
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| Vol #:
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| 41
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| C 1129
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| L. Ruff
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| Vol #:
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| 41
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| C 1130
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| B. Nicholson
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| Vol #:
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| 41
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| C 1131
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| L. Clarke
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| Vol #:
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| 41
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| C 1132
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| J. Hrbain
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| Vol #:
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| 41
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| C 1133
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| J. Lukasik
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| Vol #:
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| 41
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| C 1134
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| 4 signatures
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| Vol #:
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| 41
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| C 1135
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| M. Spicer
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| Vol #:
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| 41
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| C 1136
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| B. Sherman
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| Vol #:
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| 41
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| C 1137
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| J. Jahn
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| Vol #:
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| 41
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| C 1138
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| B. Ehlers
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| Vol #:
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| 41
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| C 1139
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| D. Bailey
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| Vol #:
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| 41
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| C 1140
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| P. Nullin
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| Vol #:
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| 41
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| C 1141
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| F. Williamson
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| Vol #:
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| 41
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| C 1142
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| Dr. A. Wheeler
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| Vol #:
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| 41
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| C 1143
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| R. Couri
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| Vol #:
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| 41
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| C 1144
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| J. Pelc
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| Vol #:
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| 41
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| C 1145
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| M. Carpenter
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| Vol #:
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| 41
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| C 1146
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| M. Pototschick
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| Vol #:
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| 41
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| C 1147
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| S. Holmes, LPN
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| Vol #:
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| 41
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| C 1148
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| M. Bowman
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| Vol #:
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| 41
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| C 1149
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| P. Chapello
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| Vol #:
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| 41
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| C 1150
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| C and L Aumen
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| Vol #:
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| 41
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| C 1151
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| E. Hruska
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| Vol #:
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| 41
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| C 1152
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| J. Sielle
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| Vol #:
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| 41
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| C 1153
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| R. Phillips
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| Vol #:
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| 41
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| C 1154
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| M. Tirpak
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| Vol #:
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| 41
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| C 1155
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| A and W Heinen
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| Vol #:
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| 41
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| C 1156
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| C. Hecke
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| Vol #:
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| 41
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| C 1157
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| R. Nelson
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| Vol #:
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| 41
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| C 1158
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| T. Koch
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| Vol #:
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| 41
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| C 1159
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| K. Foltz
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| Vol #:
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| 41
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| C 1160
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| T. McCourt
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| Vol #:
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| 41
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| C 1161
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| E. Kunz et al
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| Vol #:
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| 41
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| C 1162
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| J. Neumann
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| Vol #:
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| 41
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| C 1163
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| G and M Loegering
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| Vol #:
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| 41
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| C 1164
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| P. Derr
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| Vol #:
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| 41
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| C 1165
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| S. Schutte
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| Vol #:
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| 41
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| |
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| C 1166
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| K. Pecha
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| Vol #:
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| 41
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| C 1167
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| J and T Tabel
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| Vol #:
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| 41
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| C 1168
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| B. Berg
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| Vol #:
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| 41
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| C 1169
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| L. Lytell
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| Vol #:
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| 41
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| C 1170
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| M. Mitchell
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| Vol #:
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| 41
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| |
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| C 1171
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| R. Orbeck
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| Vol #:
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| 41
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| C 1172
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| M. Scherber
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| Vol #:
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| 41
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| C 1173
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| J. LaLonde
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| Vol #:
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| 41
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| C 1174
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| A. Hutt
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| Vol #:
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| 41
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| C 1175
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| M. Atchison
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| Vol #:
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| 41
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| C 1176
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| M. Wurmnest
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| Vol #:
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| 41
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| C 1177
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| J. Mulcahy
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| Vol #:
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| 41
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| C 1178
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| B. Ward
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| Vol #:
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| 41
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| |
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| C 1179
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| K. Smith
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| Vol #:
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| 41
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| |
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| C 1180
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| P and L Rausch
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| Vol #:
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| 41
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| |
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| C 1181
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| H. Krueger, Jr.
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| Vol #:
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| 41
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| |
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| C 1182
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| D. Porfiri
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| Vol #:
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| 41
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| |
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| C 1183
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| M. Province
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| Vol #:
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| 41
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| |
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| C 1184
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| D. Fox
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| Vol #:
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| 41
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| |
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| C 1185
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| J. Fox
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| Vol #:
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| 41
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| |
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| C 1186
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| J. Rice
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| Vol #:
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| 41
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| |
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| C 1187
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| A. Glaser
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| Vol #:
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| 41
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| C 1188
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| 407 signatures
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| Vol #:
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| 41
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| |
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| C 1189
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| M. Hutchinson
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| Vol #:
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| 41
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| C 1190
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| J and C Ely
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| Vol #:
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| 41
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| C 1191
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| M and P Tasin
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| Vol #:
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| 41
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| C 1192
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| M. Callahan
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| Vol #:
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| 41
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| C 1193
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| M. and M. Sabine
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| Vol #:
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| 41
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| C 1194
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| M. Hogan
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| Vol #:
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| 41
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| C 1195
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| D. Schuster
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| Vol #:
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| 41
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| C 1196
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| M. Tirpak
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| Vol #:
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| 41
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| |
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| C 1197
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| P. Zeller
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| Vol #:
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| 41
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| |
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| C 1198
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| C. Leon
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| Vol #:
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| 41
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| |
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| C 1199
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| Nevada Care Medical Center
|
| Vol #:
|
| 41
|
| |
|
|
| C 1200
|
| J. Farmer
|
| Vol #:
|
| 41
|
| |
|
|
| C 1201
|
| J. Sherman
|
| Vol #:
|
| 41
|
| |
|
|
| C 1202
|
| M and D Ernst
|
| Vol #:
|
| 41
|
|
| | | | | | | |
|
| |
|
| C 1203
|
| J. Fox
|
| Vol #:
|
| 41
|
| |
|
|
| C 1204
|
| D. Fox
|
| Vol #:
|
| 41
|
| |
|
|
| C 1205
|
| S. Pawelski
|
| Vol #:
|
| 41
|
| |
|
|
| C 1206
|
| M. Braxton
|
| Vol #:
|
| 42
|
| |
|
|
| C 1207
|
| D. Reilly
|
| Vol #:
|
| 42
|
| |
|
|
| C 1208
|
| P. Williams
|
| Vol #:
|
| 42
|
| |
|
|
| C 1209
|
| A. Eagan
|
| Vol #:
|
| 42
|
| |
|
|
| C 1210
|
| B. Dolph
|
| Vol #:
|
| 42
|
| |
|
|
| C 1211
|
| J. Reynolds
|
| Vol #:
|
| 42
|
| |
|
|
| C 1212
|
| E and R Gaumond
|
| Vol #:
|
| 42
|
| |
|
|
| C 1213
|
| Illigible
|
| Vol #:
|
| 42
|
| |
|
|
| C 1214
|
| T. Corrigan
|
| Vol #:
|
| 42
|
| |
|
|
| C 1215
|
| M. Malleck
|
| Vol #:
|
| 42
|
| |
|
|
| C 1216
|
| M. and P.Cason
|
| Vol #:
|
| 42
|
| |
|
|
| C 1217
|
| P. Greninger
|
| Vol #:
|
| 42
|
| |
|
|
| C 1218
|
| M. Devine
|
| Vol #:
|
| 42
|
| |
|
|
| C 1219
|
| M. Caruso
|
| Vol #:
|
| 42
|
| |
|
|
| C 1220
|
| M. McCabe
|
| Vol #:
|
| 42
|
| |
|
|
| C 1221
|
| G. Buzanowicz
|
| Vol #:
|
| 42
|
| |
|
|
| C 1222
|
| J. Cullen
|
| Vol #:
|
| 42
|
| |
|
|
| C 1223
|
| R. Everts
|
| Vol #:
|
| 42
|
| |
|
|
| C 1224
|
| M. Schlautman
|
| Vol #:
|
| 42
|
| |
|
|
| C 1225
|
| W. Small
|
| Vol #:
|
| 42
|
| |
|
|
| C 1226
|
| M. Wall
|
| Vol #:
|
| 42
|
| |
|
|
| C 1227
|
| D. Rennie
|
| Vol #:
|
| 42
|
| |
|
|
| C 1228
|
| J. Kozar
|
| Vol #:
|
| 42
|
| |
|
|
| C 1229
|
| C.Harter
|
| Vol #:
|
| 42
|
| |
|
|
| C 1230
|
| B. Mauch
|
| Vol #:
|
| 42
|
| |
|
|
| C 1231
|
| M. Panaccion
|
| Vol #:
|
| 42
|
| |
|
|
| C 1232
|
| M. Gillian
|
| Vol #:
|
| 42
|
| |
|
|
| C 1233
|
| C. Tymon
|
| Vol #:
|
| 42
|
| |
|
|
| C 1234
|
| J. Ripplinger
|
| Vol #:
|
| 42
|
| |
|
|
| C 1235
|
| J. and L. Vetsch
|
| Vol #:
|
| 42
|
| |
|
|
| C 1236
|
| I. Vetsch
|
| Vol #:
|
| 42
|
| |
|
|
| C 1237
|
| E. Ripplinger
|
| Vol #:
|
| 42
|
| |
|
|
| C 1238
|
| A. O'Brien
|
| Vol #:
|
| 42
|
| |
|
|
| C 1239
|
| M. Janbe
|
| Vol #:
|
| 42
|
|
| | | | | | | | |
|
| |
|
| C 1240
|
| L. and B. Norrell
|
| Vol #:
|
| 42
|
| |
|
|
| C 1241
|
| M Janbe
|
| Vol #:
|
| 42
|
| |
|
|
| C 1242
|
| C. Harter
|
| Vol #:
|
| 42
|
| |
|
|
| C 1243
|
| D. Rennie
|
| Vol #:
|
| 42
|
| |
|
|
| C 1244
|
| H. Sutton
|
| Vol #:
|
| 42
|
| |
|
|
| C 1245
|
| F. Bungo
|
| Vol #:
|
| 42
|
| |
|
|
| C 1246
|
| No signature
|
| Vol #:
|
| 42
|
| |
|
|
| C 1247
|
| Chidren of God for Life
|
| Vol #:
|
| 43
|
| |
|
|
| 2006D-0514
|
| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
|
|
|
|
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0007
|
| Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
|
| |
|
|
| PAV 1
|
| FDA/CDER to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0173
|
| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
|
|
|
|
|
|
|
|
|
| C 3
|
| Evanston Northwestern Healthcare
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0285
|
| Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale
|
| |
|
|
| LET 1
|
| FDA/CDER to Duramed Research, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0287
|
| determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| LET 1
|
| FDA/CDER to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0311
|
| Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
|
|
|
|
|
|
|
|
|
| C 2
|
| BenVenue Laboratories, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| C 23
|
| Vocies for Animals
|
| Vol #:
|
| 6
|
| |
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
| |
|
|
| C 43
|
| S. Sevo
|
| Vol #:
|
| 5
|
| |
|
|
| 2006P-0442
|
| Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
|
|
|
|
|
|
|
|
|
| SUP 1
|
| Orchid Healthcare
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0487
|
| Health Claim Petition: Isomaltulose and Dental Caries
|
| |
|
|
| C 1
|
| Palatinit GmbH (Palatinit/Sudzucker)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2007P-0028
|
| Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons
|
| |
|
|
| ACK 1
|
| FDA/DDM to Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
|
|
