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Dockets Management

Dockets Entered November 7, 2006
Docket # Title
1978N-0038 Sunscreen Drug Products
1988N-0258 Prescription Drug Marketing Act of 1987; Guideline
1992N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999P-1340 Declared Eternity eau de Parfum Misbranded
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2004P-0557 ANDA for a generic version of Efudex Cream(fluorouracil) cream
2005N-0446 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0383 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
2006N-0292 Unique Device Identification
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006P-0394 Revise the labeling requirements for eggs sold in the United States
1978N-0038 Sunscreen Drug Products
C 604 Estee Lauder Companies, Inc. (the Lauder Companies) Vol #: 150
1988N-0258 Prescription Drug Marketing Act of 1987; Guideline
C 149 Diversified Pharmaceuticals, Inc. Vol #: 8
1992N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992
C 143 Diversified Pharmaceuticals, Inc. Vol #: 10
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 18201 PuraPharm International HK Ltd Vol #: 167
LET 18202 Hillestad Pharmaceuticals USA Inc Vol #: 167
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
EMC 4434 M. Blake Vol #: 320
EMC 4435 M. Blake Vol #: 320
1999P-1340 Declared Eternity eau de Parfum Misbranded
EMC 658 J. Nix Vol #: 24
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 734 Mission Possible International Vol #: 10
EMC 735 Mission Possible International Vol #: 10
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1373 K. Panara Vol #: 12
EMC 1374 Akerman Senterfitt Vol #: 12
EMC 1375 A. Forward-Preedy Vol #: 12
EMC 1376 A. Darnell Vol #: 12
EMC 1377 R. Carlstedt Vol #: 12
2004P-0557 ANDA for a generic version of Efudex Cream(fluorouracil) cream
SUP 1 Valeant Pharmaceuticals International Vol #: 3
2005N-0446 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients
C 1 Estee Lauder Companies, Inc. (the Lauder Companies) Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EMC 4047 R. Van Etten Vol #: 195
EMC 4048 D. Craig Vol #: 195
EMC 4049 J. Leiss Vol #: 195
EMC 4050 J. Spetsieris Vol #: 195
EMC 4051 K. O'Neil Vol #: 195
EMC 4052 L. Frank Vol #: 195
EMC 4053 L. Lane Vol #: 195
EMC 4054 L. Moor-Anelli Vol #: 195
EMC 4055 C. Pfieffer Vol #: 195
EMC 4056 V. Dean Vol #: 195
EMC 4057 A. Spegnese Vol #: 195
EMC 4058 P. Reynolds Vol #: 195
EMC 4059 L. Westover Vol #: 195
EMC 4060 J. Manthey Vol #: 195
EMC 4061 K. Tuminello Vol #: 195
EMC 4062 V. Burde Vol #: 195
EMC 4063 R. Searle Vol #: 195
EMC 4064 M. Seamans Vol #: 195
EMC 4065 R. Baker Vol #: 195
EMC 4066 A. Roberson Vol #: 195
EMC 4067 J. Steele Vol #: 195
EMC 4068 G. Vaughan Vol #: 195
EMC 4069 B. Smith Vol #: 195
EMC 4070 R. Bohen Vol #: 195
EMC 4071 A. Nicolov Vol #: 195
EMC 4072 B. Pindara Vol #: 195
EMC 4073 A. Long Vol #: 195
EMC 4074 C. Herndon Vol #: 195
EMC 4075 A. King Vol #: 195
EMC 4076 C. Thayer Vol #: 195
EMC 4077 A. May Vol #: 195
EMC 4078 J. Mora Vol #: 195
EMC 4079 L. Bagnall Vol #: 195
EMC 4080 B. Winslette Vol #: 195
EMC 4081 L. Martin Vol #: 195
EMC 4082 J. McCoy Vol #: 195
EMC 4083 K. Gallagher Vol #: 195
2006D-0383 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
C 3 D. Jenkins Vol #: 1
C 4 M. Murphy Vol #: 1
C 5 T. Trosclair Vol #: 1
C 6 R and D Jacobson Vol #: 1
C 7 R. Gallup Vol #: 1
C 8 J. Otrembiak Vol #: 1
C 9 E and E. Emmert Vol #: 1
C 10 J. Bensman Vol #: 1
C 11 J. Wiley Vol #: 1
C 12 V. Negron Vol #: 1
C 13 M. L'Heureux Vol #: 1
C 14 K. Zinn Vol #: 1
C 15 M. Jaminet Vol #: 1
2006N-0292 Unique Device Identification
C 2 American Hospital Association (AHA) and the Association for Healthcare Resource & Materials Manag Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
C 37 K. Palmer Vol #: 7
C 38 K. Palmer Vol #: 7
C 39 K. Palmer Vol #: 7
C 40 K. Palmer Vol #: 7
C 41 The Cheney Clinic Vol #: 7
C 42 N. Bartol Vol #: 7
C 43 F. Brensinger Vol #: 7
C 44 J. Cantivary Vol #: 7
EMC 783 J. Tylor Vol #: 16
EMC 784 M. LaPine Vol #: 16
EMC 785 M. Puff Vol #: 16
EMC 786 E. Brezovec Vol #: 16
EMC 787 E. Brezovec Vol #: 16
EMC 788 W. Mora Vol #: 16
EMC 789 M. Puff Vol #: 16
EMC 790 S. Eggleston Vol #: 16
EMC 791 M. Puff Vol #: 16
EMC 792 E. B. Vol #: 16
EMC 793 C. Zoete Vol #: 16
EMC 794 L. Knoff Vol #: 16
EMC 795 L. Schmidt Vol #: 16
EMC 796 T. D. Vol #: 16
EMC 797 J. Barta Vol #: 16
EMC 798 L. Stevens Vol #: 16
EMC 799 International Hyperbaric Medical Association Vol #: 16
EMC 800 C. Maloney Vol #: 16
EMC 801 M. Puff Vol #: 16
EMC 802 M. Puff Vol #: 16
EMC 803 Uppsala University Vol #: 16
EMC 804 R. Boe Vol #: 16
EMC 805 M. Lakey Vol #: 16
EMC 806 S. Muhammad Vol #: 16
EMC 807 San Fernando Valley District California Chiropractice Association Vol #: 16
EMC 808 S. Jackson Vol #: 16
EMC 809 J. Mittelman Vol #: 16
EMC 810 T. Ascher Vol #: 16
EMC 811 J. Puff Vol #: 16
EMC 812 E. Stevens Vol #: 16
EMC 813 R. Faris Vol #: 16
EMC 814 Consumers for Dental Choice Vol #: 16
EMC 815 Consumers for Dental Choice Vol #: 16
EMC 816 Consumers for Dental Choice Vol #: 16
EMC 817 Consumers for Dental Choice Vol #: 16
EMC 818 Parker Corporate Offices Vol #: 16
EMC 819 M. Clarkson Vol #: 16
EMC 820 M. Puff Vol #: 16
EMC 821 Consumers for Dental Choice Vol #: 16
EMC 822 Consumers for Dental Choice Vol #: 16
EMC 823 J. Anderson Vol #: 16
EMC 824 F. Schubert Vol #: 16
EMC 825 C. Gillotti Vol #: 16
EMC 826 M. Butler Vol #: 16
EMC 827 M. Butler Vol #: 16
EMC 828 M. Butler Vol #: 16
EMC 829 R. Volpe Vol #: 16
EMC 830 S. Scheckner Vol #: 16
EMC 831 G. Edwards Vol #: 16
EMC 832 R. Dutton Vol #: 16
EMC 833 R. Dutton Vol #: 16
EMC 834 U. Bengtsson Vol #: 16
EMC 835 E. Grow Vol #: 16
EMC 836 S. Muralidhar Vol #: 16
EMC 837 M. Allen Vol #: 16
EMC 838 M. Velt Vol #: 16
EMC 839 M. Payne Vol #: 16
EMC 840 K. Fitzpatrick Vol #: 16
EMC 841 M. Rane Vol #: 16
EMC 842 M. Block Vol #: 16
EMC 843 M. Block Vol #: 16
EMC 844 S. Moore-Hines Vol #: 16
EMC 845 C. Mertz Vol #: 16
EMC 846 D. Angelette Vol #: 16
EMC 847 N. Woodruff Vol #: 16
EMC 848 J. Gianoli Vol #: 16
EMC 849 K. Woodrow Vol #: 16
EMC 850 Counseling That Works Vol #: 16
EMC 851 S. Shube Vol #: 16
EMC 852 L. Pezzella Vol #: 16
EMC 853 M. Bess Vol #: 16
EMC 854 Tweak Design & Communications, LLC Vol #: 16
EMC 855 P. Ellenburg Vol #: 16
EMC 856 G. Landau Vol #: 16
EMC 857 D. Schmidt Vol #: 16
EMC 858 J. Pasquale Vol #: 16
EMC 859 J. Pasquale Vol #: 16
EMC 860 C. Vol #: 16
EMC 861 P. Buonassisi Vol #: 16
EMC 862 C. Russo Vol #: 16
EMC 863 D. Bandy Vol #: 16
EMC 864 C. Zwang Vol #: 16
EMC 865 L. Skrine Vol #: 16
EMC 866 N. McBride Vol #: 16
EMC 867 R. Rogers Vol #: 16
EMC 868 M. Thompson Vol #: 16
EMC 869 M. Maher Vol #: 16
EMC 870 National Integrated Health Associates Vol #: 16
EMC 871 E. Vileve Vol #: 16
EMC 872 E. Grow Vol #: 16
EMC 873 M. Mollitor Vol #: 16
EMC 874 P. & M. Steele Vol #: 16
EMC 875 J. Wolfe Vol #: 16
EMC 876 F. Koss Vol #: 16
EMC 877 International Academy of Oral Medicine & Toxicology Vol #: 19
EMC 878 J. Sgro Vol #: 20
EMC 879 Comprehensive Health Clinic Vol #: 20
EMC 880 S. Sisk Vol #: 20
EMC 881 J. Schwartz Vol #: 20
EMC 882 M. Villano Vol #: 20
EMC 883 M. Puff Vol #: 20
EMC 884 C. Hansen Vol #: 20
EMC 885 J. Sands Vol #: 20
EMC 886 J. Hutchins Vol #: 20
EMC 887 S. Grant Vol #: 20
EMC 888 W. Fowski Vol #: 20
EMC 889 P. Moller Vol #: 20
EMC 890 J. Gruber Vol #: 20
EMC 891 L. Adams Vol #: 20
EMC 892 M. Butler Vol #: 20
EMC 893 J. Dominick Vol #: 20
EMC 894 D. Hanisch Vol #: 20
EMC 895 D. McBride Vol #: 20
EMC 896 C. Kontomerkos Vol #: 20
EMC 897 R. Edwards Vol #: 20
EMC 898 C. Butts Vol #: 20
EMC 899 K. Gaudian Vol #: 20
EMC 900 M. Gilroy Vol #: 20
EMC 901 M. Fitzgerald Vol #: 20
EMC 902 K. Eberly Vol #: 20
EMC 903 B. McNeil Vol #: 20
EMC 904 A. Dickens Vol #: 20
EMC 905 K. Weber Vol #: 20
EMC 906 M. Darling Vol #: 20
EMC 907 R. Wyatt Vol #: 20
EMC 908 A. Swanson Vol #: 20
EMC 909 M. Newell Vol #: 20
EMC 910 L. Foster Vol #: 20
EMC 911 C. Zoete Vol #: 20
EMC 912 L. McIntosh Vol #: 20
EMC 913 W. Wright Vol #: 20
EMC 914 M. Paul Vol #: 20
EMC 915 S. Wisemer Vol #: 20
EMC 916 P. Picard Vol #: 20
EMC 917 U. Vyas Vol #: 20
EMC 918 T. Danysh Vol #: 20
EMC 919 P. Davies Vol #: 20
EMC 920 B. Wright Vol #: 20
SUP 10 V. Bain Vol #: 7
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 17 R. Hussain Vol #: 6
C 18 L. Baer Vol #: 6
C 19 E. Roebuck Vol #: 6

Page created on November 8, 2006 kk

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