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| Dockets Entered
On January 16, 2007
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| Docket #
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| Title
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2003V-0125
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| Infrared Laser Aiming Device
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| 2004P-0315
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| Switch Pseudoephedrine from Over the Counter (OTC) Sales
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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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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| 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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| 2006E-0252
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| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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| 2006E-0355
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| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
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| 2006N-0061
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| Charging for Investigational Drugs
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0438
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| ANDA for Betamethasone Valerate Foam (non-aerosol), 0.12%
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| 2006P-0524
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| Withdrawal of Approval of and recall all available stock of Ziana
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| 2007M-0006
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| P050037 - Radiesse, 1.3cc and 0.3cc
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| 2007M-0007
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| P050052 - Radiesse, 1.3cc and 0.3cc
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| 2007P-0022
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| to permit an ANDA Suitability for Oral Transmucosal Fentanyl Cirate
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| 2007P-0023
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| Modify the in vitro breakpoints for penicillin and Streptococcus pneumoniae originally set by Clinical and Laboratory Standards Institute
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 55
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| M. Friese
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| Vol #:
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| 9
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| 2003V-0125
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| Infrared Laser Aiming Device
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| VRA 2
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| FDA/CDRH to Insight Technology, Inc.
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| 1
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| 2004P-0315
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| Switch Pseudoephedrine from Over the Counter (OTC) Sales
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| PDN 1
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| FDA/ORA to Pharmacists Planning Service Inc (PPSI)
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| CS 21
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| FDA/DDM
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| Vol #:
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| 240
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| OR 21
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| FDA/Administrative Law Judge
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| Vol #:
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| 240
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| RMO 10
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| FDA/CDRH/OGC
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| Vol #:
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| 240
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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 14
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| Allergy Laboratories, Inc.
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| Vol #:
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| 3
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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 765
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| 131 signatures
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| Vol #:
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| 37
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| C 766
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| A. Musavero
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| Vol #:
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| 37
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| C 767
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| J. Hogan
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| Vol #:
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| 37
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| C 768
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| R. Tissot
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| Vol #:
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| 37
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| C 769
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| R and M Lindenfelser
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| Vol #:
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| 37
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| C 770
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| T. Dygert
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| Vol #:
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| 37
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| C 771
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| 7 signatures
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| Vol #:
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| 37
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| C 772
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| A. Trew
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| Vol #:
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| 37
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| C 773
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| B. Kelly
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| Vol #:
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| 37
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| C 774
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| D and R Marsala
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| Vol #:
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| 37
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| C 775
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| H. Petullo
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| Vol #:
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| 37
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| C 776
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| M. Harrison
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| Vol #:
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| 37
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| C 777
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| F. Kelly et al
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| Vol #:
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| 37
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| C 778
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| S. Moxley
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| Vol #:
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| 37
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| C 779
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| S. Burnet
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| Vol #:
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| 37
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| C 780
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| F. Battle
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| Vol #:
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| 37
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| C 781
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| M. Bliss
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| Vol #:
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| 37
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| C 782
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| M. Bria
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| Vol #:
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| 37
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| C 783
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| R. Halverson
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| Vol #:
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| 37
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| C 784
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| J. Karlovitz
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| Vol #:
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| 37
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| C 785
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| E. Leaf
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| Vol #:
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| 37
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| C 786
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| C and W Clark
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| Vol #:
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| 37
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| C 787
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| T. Vaught
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| Vol #:
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| 37
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| C 788
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| A. Collins
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| Vol #:
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| 37
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| C 789
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| A. Pureill
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| Vol #:
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| 37
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| C 790
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| H. Meany
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| Vol #:
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| 37
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| C 791
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| A and G Todd
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| Vol #:
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| 37
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| C 792
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| J. Liston
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| Vol #:
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| 37
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| C 793
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| J. Neumann
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| Vol #:
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| 37
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| C 794
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| A. BAttle
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| Vol #:
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| 37
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| C 795
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| A. Barta
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| Vol #:
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| 37
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| C 796
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| T. Bressler
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| Vol #:
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| 37
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| C 797
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| K. Sommers
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| Vol #:
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| 37
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| C 798
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| D. Opferman
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| Vol #:
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| 37
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| C 799
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| P. Messina
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| Vol #:
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| 37
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| C 800
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| R. Bushmaker
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| Vol #:
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| 37
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| C 801
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| K. Kols
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| Vol #:
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| 37
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| C 802
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| R. Curley
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| Vol #:
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| 37
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| C 803
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| L. Fullenjonk
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| Vol #:
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| 37
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| C 804
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| D. Foley
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| Vol #:
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| 37
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| C 805
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| F. Ollerenshaw
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| Vol #:
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| 37
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| C 806
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| E. Carlton
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| Vol #:
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| 37
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| C 807
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| Dr. P. Klump, DDS
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| Vol #:
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| 37
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| C 808
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| L. Persson
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| Vol #:
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| 37
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| C 809
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| B and C McCarthy
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| Vol #:
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| 37
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| C 810
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| B. Persson
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| Vol #:
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| 37
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| C 811
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| Illigible
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| Vol #:
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| 37
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| C 812
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| C. Martin
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| Vol #:
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| 37
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| C 813
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| M. Kemper
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| Vol #:
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| 37
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| C 814
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| M. O'Grady
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| Vol #:
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| 37
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| C 815
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| S and A Craig
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| Vol #:
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| 37
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| C 816
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| S Martensen
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| Vol #:
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| 37
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| C 817
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| P. Thayer
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| Vol #:
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| 37
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| C 818
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| L. Pillar
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| Vol #:
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| 37
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| C 819
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| D. Nichols
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| Vol #:
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| 37
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| C 820
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| 32 signatures
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| Vol #:
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| 37
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| C 821
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| L and C Yeary
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| Vol #:
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| 38
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| C 822
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| L. Favreau
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| Vol #:
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| 38
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| C 823
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| M. Hurley, OP
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| Vol #:
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| 38
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| C 824
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| D. Frame
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| Vol #:
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| 37
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| C 825
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| M. Cortney, CPA, CIA
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| Vol #:
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| 37
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| C 826
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| T. Castilanes
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| Vol #:
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| 37
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| C 827
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| J. Howland, MD
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| Vol #:
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| 37
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| C 828
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| M. Diedospiol
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| Vol #:
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| 37
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| C 829
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| G. Trevaskis
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| Vol #:
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| 37
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| C 830
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| L. Pototschnik
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| Vol #:
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| 37
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| C 831
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| National Catholic Bioethics Center
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| Vol #:
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| 37
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| |
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| C 832
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| W. Raiser
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| Vol #:
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| 38
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| |
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| C 833
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| Children of God for Life
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| Vol #:
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| 37
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| |
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| C 834
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| R. Castilano
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| Vol #:
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| 38
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| C 835
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| M. Schultz
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| Vol #:
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| 37
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| C 836
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| M. Faiola
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| Vol #:
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| 37
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| |
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| C 837
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| K. Cuzzola
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| Vol #:
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| 37
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| |
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| C 838
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| S. Sanlhez
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| Vol #:
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| 38
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| C 839
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| No siganture
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| Vol #:
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| 38
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| |
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| C 840
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| B. Broader
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| Vol #:
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| 38
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| |
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| C 841
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| 2 signatures
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| Vol #:
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| 38
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| |
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| C 842
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| 2 signatures
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| Vol #:
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| 38
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| |
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| C 843
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| K and B Moran
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| Vol #:
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| 38
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| |
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| C 844
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| C. Pawelski
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| Vol #:
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| 38
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| |
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| C 845
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| 55 signatures
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| Vol #:
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| 38
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| |
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| C 846
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| J. Betlach
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| Vol #:
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| 38
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| C 847
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| D. Thimons
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| Vol #:
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| 38
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| |
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| C 848
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| 407 signatures
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| Vol #:
|
| 38
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| |
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| C 849
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| T. Tabel
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| Vol #:
|
| 38
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| |
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| C 850
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| 151 signatures
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| Vol #:
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| 38
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| |
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| C 851
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| 27 signatures
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| Vol #:
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| 38
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| |
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| C 852
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| 175 signatures
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| Vol #:
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| 38
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| |
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| C 853
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| J Gustke et al
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| Vol #:
|
| 37
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| |
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| C 854
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| 6 signatures
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| Vol #:
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| 38
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| |
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| C 855
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| G. Lallement
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| Vol #:
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| 38
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| |
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| C 856
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| 16 signatures
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| Vol #:
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| 38
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| |
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| C 857
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| 6 signatures
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| Vol #:
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| 38
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| |
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| C 858
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| S. Reilly
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| Vol #:
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| 38
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| |
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| C 859
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| C. Niedos
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| Vol #:
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| 38
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| |
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| C 860
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| 8 signatures
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| Vol #:
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| 38
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| |
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| C 861
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| K. Maggio, M.D.
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| Vol #:
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| 38
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| |
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| C 862
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| D and A O'Connor
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| Vol #:
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| 38
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| |
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| C 863
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| E. Hurley
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| Vol #:
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| 38
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| |
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| C 864
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| J. Anzelmo
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| Vol #:
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| 38
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| |
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| C 865
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| A. Shaw
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| Vol #:
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| 38
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| |
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| C 866
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| A. Morabito
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| Vol #:
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| 38
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| |
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| C 867
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| E. Blonski
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| Vol #:
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| 38
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| |
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| C 868
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| Misty
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| Vol #:
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| 38
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| |
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| C 869
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| V and J Sanctafamilia
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| Vol #:
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| 38
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| |
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| C 870
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| K and C DeCeault
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| Vol #:
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| 38
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| |
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| C 871
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| E. Bauer
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| Vol #:
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| 38
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| |
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| C 872
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| M. Carpenter
|
| Vol #:
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| 38
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| |
|
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| C 873
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| J. Hogan
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| Vol #:
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| 38
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| |
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| C 874
|
| 10 signatures
|
| Vol #:
|
| 38
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| |
|
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| C 875
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| 6 signatures
|
| Vol #:
|
| 38
|
|
| | | | | | | | |
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| |
|
| C 876
|
| J and D Bibb
|
| Vol #:
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| 38
|
| |
|
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| C 877
|
| J. Mattiace
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| Vol #:
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| 38
|
| |
|
|
| C 878
|
| C. Webb
|
| Vol #:
|
| 38
|
| |
|
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| C 879
|
| 5 signatures
|
| Vol #:
|
| 38
|
| |
|
|
| C 880
|
| B and J Smith
|
| Vol #:
|
| 38
|
| |
|
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| C 881
|
| Florida Catholic Conference
|
| Vol #:
|
| 38
|
| |
|
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| C 882
|
| J. Kucia
|
| Vol #:
|
| 38
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| |
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| C 883
|
| M. Dibling
|
| Vol #:
|
| 38
|
| |
|
|
| C 884
|
| L. Poteet
|
| Vol #:
|
| 38
|
| |
|
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| C 885
|
| 4 signatures
|
| Vol #:
|
| 38
|
| |
|
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| C 886
|
| L. Jones
|
| Vol #:
|
| 38
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| |
|
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| C 887
|
| R and R Dufour
|
| Vol #:
|
| 38
|
| |
|
|
| C 888
|
| No signature
|
| Vol #:
|
| 38
|
| |
|
|
| C 889
|
| J. Weaver
|
| Vol #:
|
| 38
|
| |
|
|
| C 890
|
| B. Grites
|
| Vol #:
|
| 38
|
| |
|
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| C 891
|
| L. Martineau
|
| Vol #:
|
| 38
|
| |
|
|
| C 892
|
| K. Makara
|
| Vol #:
|
| 38
|
| |
|
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| C 893
|
| J. Donnelly
|
| Vol #:
|
| 38
|
| |
|
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| C 894
|
| K. Novcaski
|
| Vol #:
|
| 38
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| |
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| C 895
|
| No signature
|
| Vol #:
|
| 38
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| |
|
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| C 896
|
| A. Meffert
|
| Vol #:
|
| 38
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| |
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| C 897
|
| Mary M.
|
| Vol #:
|
| 38
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| |
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| C 898
|
| S. Lesnar
|
| Vol #:
|
| 38
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| |
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| C 899
|
| S. Kinserski
|
| Vol #:
|
| 38
|
| |
|
|
| 2006E-0252
|
| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0261
|
| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0355
|
| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0061
|
| Charging for Investigational Drugs
|
| |
|
|
| C 1
|
| UnitedHealth Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0062
|
| Expanded Access to Investigational Drugs for Treatment Use
|
| |
|
|
| C 3
|
| UnitedHealthcare Group
|
| Vol #:
|
| 1
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|
| | | | | | | | |
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| |
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| |
|
|
| C 42
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| E. Donohoe
|
| Vol #:
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| 5
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| |
|
|
| 2006P-0438
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| ANDA for Betamethasone Valerate Foam (non-aerosol), 0.12%
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| |
|
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| C 2
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| Connetics Corporation (Connetics)
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| Vol #:
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| 1
|
|
| |
|
| 2006P-0524
|
| Withdrawal of Approval of and recall all available stock of Ziana
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| |
|
|
| LET 1
|
| Medicis Pharmaceutical Corporation
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| Vol #:
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| 1
|
| |
|
|
| 2007M-0006
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| P050037 - Radiesse, 1.3cc and 0.3cc
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| |
|
|
| AAV 1
|
| BioForm Medical, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0007
|
| P050052 - Radiesse, 1.3cc and 0.3cc
|
| |
|
|
| AAV 1
|
| BioForm Medical, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0022
|
| to permit an ANDA Suitability for Oral Transmucosal Fentanyl Cirate
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| |
|
|
| ACK 1
|
| FDA /DDM to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0023
|
| Modify the in vitro breakpoints for penicillin and Streptococcus pneumoniae originally set by Clinical and Laboratory Standards Institute
|
| |
|
|
| ACK 1
|
| FDA/DDM to Victor L. Yu, M.D.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Victor L. Yu, M.D.
|
| Vol #:
|
| 1
|
|
|
