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Dockets Management
Dockets Entered On October 12, 2005
Table of Contents
Docket # Title
1979N-0043 Lakes of Color Additives
1985N-0241 Hematology & Pathology DEV/PMA/Automoted Blood Cell Seper
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2004P-0263 To declare that the drug Cefixine chewable tablets, 100 mg, 150 mg, and 200 mg are suitable for an abbreviated new drug application ( ANDA)
2004P-0409 metoclopramide hydrochloride orally disintegrating tablets 5 mg & 10 mg suitable for ANDA
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
2004Q-0201 Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
2005D-0195 Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
2005D-0288 International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
2005N-0393 Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
2005P-0121 Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
2005P-0409 Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
2005V-0314 Laser Light Show
1979N-0043 Lakes of Color Additives
REF 1 No Submitter Vol #: 3
1985N-0241 Hematology & Pathology DEV/PMA/Automoted Blood Cell Seper
REF 1 No Submitter Vol #: 5
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7506 W Whitehurst and 41 signatures Vol #: 319
2004P-0263 To declare that the drug Cefixine chewable tablets, 100 mg, 150 mg, and 200 mg are suitable for an abbreviated new drug application ( ANDA)
PAV 1 HFD-600 to Lupin Pharmaceuticals Inc Vol #: 1
2004P-0409 metoclopramide hydrochloride orally disintegrating tablets 5 mg & 10 mg suitable for ANDA
WDL 1 Lachman Consultant Services Inc Vol #: 1
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
LET 10 HFS-800 to Solae LLC Vol #: 9
2004Q-0201 Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
LET 10 H J Heinz Company Vol #: 16
2005D-0195 Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
C 1 American College of Radiology Vol #: 1
2005D-0288 International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
C 6 Parenteral Drug Association (PDA) Vol #: 1
EC 3 LearningPlus Vol #: 1
EC 4 Generic Pharmaceutical Association Vol #: 1
2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
C 67 J A Nailboff MD Vol #: 9
C 68 J F Smith MD Vol #: 9
C 69 Mrs C Harford Vol #: 9
C 70 University of Louisville Health Sciences Center Vol #: 9
C 71 D Ruckdeschel Vol #: 9
C 72 Form Letter count 54 Vol #: 10
C 73 Form Letter Count 3 Vol #: 11
EC 562 Mrs. Anna Daniel Vol #: 6
EC 563 Mrs. Rosemary Woerner Vol #: 6
EC 564 Dr. Patrick Sullivan Vol #: 6
EC 565 Mrs. Christopher Peters Vol #: 6
EC 566 Mrs. Annette Burgess Vol #: 6
EC 567 Mr. Dominic Colvert Vol #: 6
EC 568 NA Vol #: 6
EC 569 Miss. Kathleen Tansley Vol #: 6
EC 570 Mr. Andrew Hagen Vol #: 6
EC 571 Mr. William Burgess Vol #: 6
EC 572 Mr. John Naughton Vol #: 6
EC 573 Mr. William Voss Vol #: 6
EC 574 Retired Vol #: 6
EC 575 Mr. Ed Cunningham Vol #: 6
EC 576 Miss. Lisa J. Nigro Vol #: 6
EC 577 Ms. Kristina Hastings Vol #: 6
EC 578 Ms. Richard Mauro Vol #: 6
EC 579 Miss. Mary Veronica Price Vol #: 6
EC 580 Mr. Dana Farmer Vol #: 6
EC 581 Mr. Phil Wolf Vol #: 6
EC 582 Dr. Francis Casey Vol #: 6
EC 583 Mrs. Patricia Brandon Vol #: 6
EC 584 Ms. Margaret Victor Vol #: 6
EC 585 WOMEN'S HEALTH ISSUES Vol #: 6
EC 586 Mr. Gregory Doran Vol #: 6
EC 587 Ms. Christine Buonopane Vol #: 6
EC 588 Mr. David Craig Vol #: 6
EC 589 Miss. Peggy Napier Vol #: 6
EC 590 Mrs. Joyce Kinmont Vol #: 6
EC 591 Mrs. Mary Theoret Vol #: 6
EC 592 Mr. David Ramsey Vol #: 6
EC 593 Former District Deputy, NJ State Council, Knights Vol #: 6
EC 594 Mrs. Vicki Charocopos Vol #: 6
EC 595 Ms. Linda Soyars Vol #: 6
EC 596 Ms. Robin Johnson Vol #: 6
EC 597 Mrs. Deborah Thieme Vol #: 6
EC 598 Mr. Christopher Horrocks Vol #: 6
EC 599 Mr. Colin Donovan Vol #: 6
EC 600 none Vol #: 6
EC 601 Mr. Craig Modrzynski Vol #: 6
EC 602 Mrs. Carolyn Mulligan Vol #: 6
EC 603 Ms. Estelle padawer Vol #: 6
EC 604 None Vol #: 6
EC 605 Mrs. Rebecca Harrington Vol #: 6
EC 606 Personal Comment Vol #: 6
EC 607 n/a Vol #: 6
EC 608 Mrs. MARSHA DELAY Vol #: 6
EC 609 Mr. Daniel Billingsley Vol #: 6
EC 610 Mrs. Frances Koch Vol #: 6
EC 611 Mrs. Anne Risti Vol #: 6
EC 612 Michian State Medical Society Vol #: 6
EC 613 self Vol #: 6
EC 614 Mr. Kevin Doran Vol #: 6
EC 615 Ms. Mary Gillman Vol #: 6
EC 616 Mrs. marisa marchi Vol #: 6
EC 617 Mr. Jackie Barnes Vol #: 6
EC 618 Dr. Diane Poythress Vol #: 6
EC 619 C Thomas Gott MD LTD Vol #: 6
EC 620 Ms. Marie Fordtner Vol #: 6
EC 621 Mr. Randall Malick Vol #: 6
EC 622 Mrs. Margaret Tooley Vol #: 6
EC 623 Concerned Parents and Citizens of Fullerton Vol #: 6
EC 624 Mrs. Natalie Frey Vol #: 6
EC 625 Mrs. Janet Crook Vol #: 6
EC 626 Gerald L. Peer, MD Vol #: 6
EC 627 Mr. Dale Olsen Vol #: 6
EC 628 Mr. Ted Rowell Vol #: 6
EC 629 Miss. Cindy Morgan Vol #: 6
EC 630 Miss. Maria Bremberg Vol #: 6
EC 631 Mrs. B Lang Vol #: 6
EC 632 Ms. Amy Seymour Vol #: 6
EC 633 Consumer Vol #: 6
EC 634 Ms. Beth Hill Vol #: 6
EC 635 Mr. Leo Paquette, RPh Vol #: 6
EC 636 Ms. Maura Mudd Vol #: 6
EC 637 Mrs. Natalie Rios Vol #: 6
EC 638 Mr. Gary Allen Vol #: 6
EC 639 Mrs. Bonnie Sager Vol #: 6
EC 640 Dr. Susan Hartley Vol #: 6
EC 641 Miss. Nellie Christian Vol #: 6
EC 642 None Vol #: 6
EC 643 None Vol #: 6
EC 644 Mrs. Lucille Mattair Vol #: 6
EC 645 Mr. Robert Fricke Vol #: 6
EC 646 Mr. Raymond Settle Vol #: 6
EC 647 Mother, wife, and someone who miscarried a child Vol #: 6
EC 648 Mrs. Darlene Lerche Vol #: 6
EC 649 Mrs. Jodi Wagner Vol #: 6
EC 650 Concerned Women for America Vol #: 6
EC 651 Mrs. Mary Rapp Vol #: 6
EC 652 Mrs. Cynthia Choo Vol #: 6
EC 653 HOLY LOVE MINISTRIES Vol #: 6
EC 654 Mr. Peter Kortebein Vol #: 6
EC 655 Mrs. Suzan Marcy Vol #: 6
EC 656 Christ Luthran Church Vol #: 6
EC 657 Mr. James Thompson Vol #: 6
EC 658 Valor, Alianzas de Asociaciones, A.C. Vol #: 6
EC 659 Self-Employed Vol #: 6
EC 660 Mrs. Janell Hope Vol #: 6
EC 661 none Vol #: 6
EC 662 KAISER Vol #: 6
EC 663 Mr. Anthony Hunter Vol #: 6
EC 664 Mrs. Angela Saldarriaga Vol #: 6
EC 665 Our Lady of Hope Academy Vol #: 6
EC 666 Mr. Don Vasas Vol #: 6
EC 667 Mrs. Cynthia Raschke Vol #: 6
EC 668 Mrs. Anna Vrankar Vol #: 6
EC 669 Walgreens Vol #: 6
EC 670 Miss. Alisa Craddock Vol #: 6
EC 671 Mrs. Mary Frances Friedl Vol #: 6
EC 672 The Atonement Academy Vol #: 6
EC 673 Concerned Citizens Vol #: 6
EC 674 Mr. John Foley Vol #: 6
EC 675 Dr. Catherine Shoemaker Vol #: 6
EC 676 Mrs. Adele Todd Vol #: 6
EC 677 Miss. Jennifer Gordon Vol #: 6
EC 678 Ms. Kathleen Socha Vol #: 6
EC 679 Children of God for Life Vol #: 6
EC 680 Christian Leadership Alliance in Memphis Vol #: 6
EC 681 Mrs. Kathryn Anthony Vol #: 6
EC 682 Mr. Todd Mackiewicz Vol #: 6
EC 683 Mr. Richard Cochran Vol #: 6
EC 684 Mr. JOHN HARRIS Vol #: 6
EC 685 Ms. Martha Dudley Vol #: 6
EC 686 Mr. Russell Shaw Vol #: 6
EC 687 Mrs. Doris Messier Vol #: 6
EC 688 Mrs. margaret radigan Vol #: 6
EC 689 Mrs. Pamela Al-Bawab Vol #: 6
EC 690 n/a Vol #: 6
EC 691 Mr. Thomas Carter Vol #: 6
EC 692 Ms. Margie Shealy Vol #: 6
EC 693 Mr. Sidney Baker Vol #: 6
EC 694 Ms. J Conroy Vol #: 6
EC 695 Franciscan Univ. Steubenville OH, Austrian Campus Vol #: 6
EC 696 Mrs. Judith A. Croxton Vol #: 6
EC 697 High School Teacher Vol #: 6
EC 698 Mrs. Kari Spencer Vol #: 6
EC 699 Mrs. Christine Lund-Molfese Vol #: 6
EC 700 Mrs. Claudia Kasprzak Vol #: 6
EC 701 Florida Catholic Conference Vol #: 6
EC 702 Mrs. Suzanne Doller Vol #: 6
EC 703 n/a Vol #: 6
EC 704 Mrs. Bonnie Hackett Vol #: 6
EC 705 Ms. Nancy Cariglio Vol #: 6
EC 706 Mr. Abraham Weaver Vol #: 6
EC 707 Ms. Laura Davidson Vol #: 6
EC 708 Mr. Don Stubblefield Vol #: 6
EC 709 Mrs. Regina Defauw Vol #: 6
EC 710 Mrs. Naomi Devine Vol #: 6
EC 711 Mrs. Kathleen Steinmetz Vol #: 6
EC 712 Mrs. Kathleen J. den Breejen Vol #: 6
EC 713 Mrs. Betty Feldman Vol #: 6
EC 714 Mr. Wayne McCormick Vol #: 6
EC 715 Mr. Greg Piepel Vol #: 6
EC 716 Citizen Vol #: 6
EC 717 Mr. Joseph Gorini Vol #: 6
EC 718 Mr. Michael Kreis Vol #: 6
EC 719 Rachel Ministry Vol #: 6
EC 720 None Vol #: 6
EC 721 Ms. Madeline Ashley Vol #: 6
EC 722
Attachment
Mr. Wendell Neugebauer Vol #: 6
EC 723 Ms. Cheryl Mayerik Vol #: 6
EC 724 Mrs. Mary Roybal Vol #: 6
EC 725 Mrs. Feleiteau Epley Vol #: 6
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
C 1 Pfizer Inc Vol #: 1
2005N-0393 Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
N 1 FDA Vol #: 1
2005P-0121 Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
C 6
Tab A, Tab B
DJ Ortho Vol #: 3
C 7 Core Medical Center Vol #: 3
2005P-0409
Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
SUP 1 Sterne Kessler Goldstein & Fox Vol #: 1
2005V-0314 Laser Light Show
VRA 1 HFZ-200 to Anthony Fransen Productions Vol #: 1

Page created on October 27, 2005 dp

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