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Dockets Management
Dockets Entered On February 7, 2006
Table of Contents
Docket # Title
2004D-0555 Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
2004P-0074 oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
2005N-0157 Agency Information Collection Activities: Proposed Collection; Postmarketing Adverse Drug Experience Reporting
2005N-0285 Current Good Manufacturing Practice Regulation and Investigational New Drugs
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-0374 Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
2005P-0096 ANDA 77-421 Loratadine Syrup- Hives relief
2005P-0323 Immediately remove Adderall and Adderall XR from the market for safety reasons
2005P-0383 refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005P-0459 To enforce ban on carbon monoxide gas in fresh meat packaging
2006N-0045 Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT); Public Workshop; Request for Comments
2004D-0555 Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
C 6 Catholics for a Free Choice (CFFC) Vol #: 1
2004P-0074 oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
SUP 4
Attachment 		Savient Pharmaceuticals, Inc. (Savient) Vol #: 1
2005N-0157 Agency Information Collection Activities: Proposed Collection; Postmarketing Adverse Drug Experience Reporting
N 2 FDA Vol #: 1
2005N-0285 Current Good Manufacturing Practice Regulation and Investigational New Drugs
C 1 University of Texas MD Anderson Cancer Center 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 498 J. Flippen Vol #: 165
2005N-0374 Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
C 5 S. Mawhinney Vol #: 1
C 6 M. Supler Vol #: 1
2005P-0096 ANDA 77-421 Loratadine Syrup- Hives relief
LET 2 HFD-007 to Silarx Pharmaceuticals, Inc Vol #: 2
2005P-0323 Immediately remove Adderall and Adderall XR from the market for safety reasons
LET 1 HFD-005 to David S. Lowe Vol #: 1
2005P-0383 refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
SUP 1 Savient Pharmaceuticals, Inc. Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 544 C. Frost Vol #: 6
C 545 M. Anderson Vol #: 6
C 546 C. Ballman Vol #: 6
C 547 G. Nybo Vol #: 6
C 548 B. Miller Vol #: 6
C 549 M. LeClaire Vol #: 6
C 550 S. Gioiosa Vol #: 6
C 551 S. Moore Vol #: 6
C 552 L. Dome Vol #: 6
C 553 N. Huggins Vol #: 6
C 554 N. Alsaker Vol #: 6
C 555 P. Kirscher Vol #: 6
C 556 C. Borwich Vol #: 6
C 557 A. Robin Vol #: 6
C 558 N. O'Connor Vol #: 6
C 559 E. Hiatt Vol #: 6
C 560 C. Slater Vol #: 6
C 561 B. Slater Vol #: 6
C 562 E. Phillips Vol #: 6
C 563 K. Janiec Vol #: 6
C 564 J. Giese Vol #: 6
C 565 Eligible Vol #: 6
C 566 F. Johnson Vol #: 6
C 567 K. Martin Vol #: 6
C 568 J. Weatherford Vol #: 6
C 569 C. Jensen Vol #: 6
C 570 J. Gawryluk Vol #: 6
C 571 A. Phillips Vol #: 6
C 572 S. Rhone Vol #: 6
C 573 M. Morford Vol #: 6
C 574 A. Ladd Vol #: 6
C 575 M. McLaughlin Vol #: 6
C 576 K. Harrold Vol #: 6
C 577 J. Johnson Vol #: 6
C 578 L. Ozkayruk Vol #: 6
C 579 M. Wiggall Vol #: 6
C 580 C. Downs Vol #: 6
C 581 L. Nash Vol #: 6
C 582 National Community Pharmacists Association (NCPA) Vol #: 6
C 583 B. Appelgreen Vol #: 6
C 584 P. Califano Vol #: 6
C 585 J. Cornell Vol #: 6
C 586 W. Tubbs Vol #: 6
C 587 S. Duncan Vol #: 6
C 588 T. Smith Vol #: 6
C 589 G. Parker Vol #: 6
C 590 J. Buck Vol #: 6
C 591 D. Friedman Vol #: 6
C 592 L. Smith Vol #: 6
C 593 B. Hendren Vol #: 6
C 594 M. Keller Vol #: 6
C 595 D. Oelkers Vol #: 6
C 596 L. Duale Vol #: 6
C 597 J. Johnston Vol #: 6
C 598 S. Smith Vol #: 6
C 599 S. Garber Vol #: 6
C 600 K. Davisas Vol #: 6
C 601 K. Strand Vol #: 6
C 602 M. Oberg Vol #: 6
C 603 J. Tamer Vol #: 6
C 604 B. Krich Vol #: 6
C 605 N. Camel Vol #: 6
C 606 P. Costa Vol #: 6
C 607 V. Obermeyer Vol #: 6
C 608 C. Reynolds Vol #: 6
C 609 D. Murtagh Vol #: 6
C 610 M. Parman Vol #: 6
C 611 D. Keriazes Vol #: 6
EC 892 individual for compounded bio-identical hormones Vol #: 7
EC 893 Mrs. DENISE STEICHEN Vol #: 7
EC 894 Ms. Laura Lee Tucker Vol #: 7
EC 895 Ms. Nancy Lorenzen Vol #: 7
EC 896 Mrs. BJ Williams Vol #: 7
EC 897 Ms. Dana Shafer Vol #: 7
EC 898 Mrs. Marilyn Storey Vol #: 7
EC 899 Mrs. Kathryn Hitesman Vol #: 7
EC 900 Mrs. Lucinda Conway Vol #: 7
EC 901 Mrs. Brenda Martin Vol #: 7
EC 902 Mrs. Patricia Galone Vol #: 7
EC 903 Mrs. LAURIE ZOGRAFOS Vol #: 7
EC 904 Mrs. JEAN MANDEL Vol #: 7
EC 905 Mrs. Rhonda Powell Vol #: 7
EC 906 Mrs. Leslie Gaylord Vol #: 7
EC 907 Mrs. Naomi Loomis Vol #: 7
EC 908 Mrs. marina rosso Vol #: 7
EC 909 Mrs. Donna Dees Vol #: 7
EC 910 Mrs. Jolie Rochin Vol #: 7
EC 911 Mrs. Marina Rosso Vol #: 7
EC 912 Mrs. Lynn Nyzen Vol #: 7
EC 913 Mrs. Barb Wills Vol #: 7
EC 914 Mrs. Therese Evans Vol #: 7
EC 915 Mrs. brenda smith Vol #: 7
EC 916 Ms. Kathleen Burns Vol #: 7
EC 917 Ms. Lynde Moore Vol #: 7
EC 918 Mrs. Karen Baker Vol #: 7
EC 919 Mrs. Veronica Catenaro Vol #: 7
EC 920 Ms. Deborah Schneider Vol #: 7
EC 921 Mrs. sharon abbott Vol #: 7
EC 922 Mrs. Rebecca Lehmann Vol #: 7
EC 923 Mrs. Nicole Drazen Vol #: 7
EC 924 Ms. Anna Kingsley Vol #: 7
EC 925 Ms. Tara Murphy Vol #: 7
EC 926 Mrs. Darlene Brown Vol #: 7
EC 927 Mrs. Betty Falik Vol #: 7
EC 928 Ms. Rita Quinton Vol #: 7
EC 929 Mrs. Carolyn Hoover Vol #: 7
EC 930 Mrs. Lynda Rodriguez Vol #: 7
EC 931 Mrs. Pamela Grau Vol #: 7
EC 932 Ms. Janet Corcoran Vol #: 7
EC 933 Mrs. marta akashe Vol #: 7
EC 934 Ms. Rene Ratchek Vol #: 7
EC 935 Ms. Arlene Keros Keros Vol #: 7
EC 936 Mrs. andrea lapan Vol #: 7
EC 937 Ms. Barbara Barlow Vol #: 7
EC 938 Mrs. Melinda Sculatti Vol #: 7
EC 939 Mr. Thomas Dean Vol #: 7
EC 940 Ms. Ann Webre Vol #: 7
EC 941 Ms. Peg Alford Vol #: 7
EC 942 Ms. Brenda Anderson Vol #: 7
EC 943 Mrs. Kristine Kirby Vol #: 7
EC 944 Mrs. Fran Aboyoun Vol #: 7
EC 945 Mr. Dan Drazen Vol #: 7
EC 946 Ms. Merry Cibula Vol #: 7
EC 947 Mrs. Donna Grzywinski Vol #: 7
EC 948 Mrs. Barbara Hix-Hall Vol #: 7
EC 949 Mrs. Frances Picone Vol #: 7
EC 950 Ms. Julie Faughnan Vol #: 7
EC 951 Mrs. Suzanne Grigsby Vol #: 7
EC 952 Mrs. Betty Shapiro Vol #: 7
EC 953 Ms. Diana Pile Vol #: 7
EC 954 Mrs. Laura Trelford Vol #: 7
EC 955 Mrs. pat larson Vol #: 7
EC 956 Ms. Norma Coleman Vol #: 7
EC 957 Ms. C. Marrone Vol #: 7
EC 958 Alzheimer's Association Vol #: 7
EC 959 Ms. Margaret Johansen Vol #: 7
EC 960 Ms. Sue Merritt Vol #: 7
EC 961 Central Iowa Compounding Vol #: 7
EC 962 Mrs. Corinne Blanco Vol #: 7
EC 963 Mrs. Deborah Stevens Vol #: 7
EC 964 Mrs. Cheryl Irons Vol #: 7
EC 965 Mrs. Zulma Pereira Vol #: 7
EC 966 Mrs. Lynanne Reed Vol #: 7
EC 967 Ms. Cheryl Cranston Vol #: 7
EC 968 Ms. Noreen Nickolas Vol #: 7
EC 969 Ms. Anya Achtenberg Vol #: 7
EC 970 Mrs. Pat Remund Vol #: 7
EC 971 Mrs. jane bowles Vol #: 7
EC 972 Mrs. Arlene L. Jenkins Vol #: 7
EC 973 Mrs. Holly Perrone Vol #: 7
EC 974 Mrs. Terri Lindow Vol #: 7
EC 975 Mrs. Joyce DeBolt Vol #: 7
EC 976 Ms. Cindee Barrett Vol #: 7
EC 977 Ms. cailen balabanov Vol #: 7
EC 978 Hypothyroidism Support Group Vol #: 7
EC 979 Mrs. Andrea Reilley Vol #: 7
EC 980 Ms. Cassandara Selberg Vol #: 7
EC 981 Mrs. Jeannette Dole Vol #: 7
EC 982 Mrs. patricia berends Vol #: 7
EC 983 Dr. Vol #: 7
EC 984 Ms. Ofelia Garcia Vol #: 7
EC 985 Ms. Ilene Mesnard Vol #: 7
EC 986 Ms. Ana Ramirez Vol #: 7
EC 987 Ms. Debra Ryll Vol #: 7
EC 988 Ms. Cheryl Poholek Vol #: 7
EC 989 Mrs. Sally De Felice Clemens Vol #: 7
EC 990 Ms. A Lennox Vol #: 7
EC 991 Mrs. miryam wimhurst Vol #: 7
EC 992 Ms. Virginia Houser Vol #: 7
EC 993 Ms. Debi Poinar Vol #: 7
EC 994 Ms. Susan Strecker Vol #: 7
EC 995 Ms. Barbara Beckett Vol #: 7
EC 996 Mrs. Michelle Hagopian Vol #: 7
EC 997 Ms. Lisa Kirchenwitz Vol #: 7
EC 998 Mrs. EILEEN FORD Vol #: 7
EC 999 Ms. Cara Cameron Vol #: 7
EC 1000 Mrs. Shannon Struik Vol #: 7
EC 1001 Mr. Barry Shafer Vol #: 7
EC 1002 Ms. Nancy Burton Vol #: 7
EC 1003 Mrs. Tonya Parker Vol #: 7
EC 1004 Mrs. LeAnn Nealz Vol #: 7
EC 1005 Ms. Bobby Davis Vol #: 7
EC 1006 Miss. Stacey Schnee Vol #: 7
EC 1007 Basically Business/Alternative Choices Vol #: 7
EC 1008 Ms. Morgaine Beck Vol #: 7
EC 1009 Ms. Lynette Macias Vol #: 7
EC 1010 Mrs. Donna Balsz Vol #: 7
EC 1011 Mrs. Jennifer Doucet Vol #: 7
EC 1012 Mrs. Dianne Reidy Vol #: 7
EC 1013 Mrs. Christine Nix Vol #: 7
EC 1014 Arbonne International Vol #: 7
EC 1015 Mrs. CARLA CHAMBERS-LYNDE Vol #: 7
EC 1016 Mrs. Barbara Rich Vol #: 7
EC 1017 Ms. charlie palmer Vol #: 7
EC 1018 Mrs. Bobby Swaile Vol #: 7
EC 1019 Ms. Jennifer Lude Vol #: 7
EC 1020 Mrs. Dorothy Holder Vol #: 7
EC 1021 Mrs. Barbara Barnes Vol #: 7
EC 1022 Jennifer Medley Nutrition Vol #: 7
EC 1023 Mrs. Rosemary Lort Vol #: 7
EC 1024 Ms. Edith Webb Vol #: 7
EC 1025 Mrs. Anita Krebs Vol #: 7
EC 1026 Ms. Lori Boris Vol #: 7
EC 1027 The Menopause Center of United Hospital Vol #: 7
EC 1028 Ms. Paula Wegeforth Vol #: 7
EC 1029 Ms. Patricia Shannon Vol #: 7
EC 1030 Ms. sandra moon Vol #: 7
EC 1031 Mrs. Roxane Daigle Vol #: 7
EC 1032 Ms. Barbara Ellquist Vol #: 7
EC 1033 Miss. Jerri Roy Vol #: 7
EC 1034 Ms. Kelley Maher Vol #: 7
EC 1035 Mr. Dennis Maher Vol #: 7
EC 1036 Ms. Shelley Higgins Vol #: 7
EC 1037 Mrs. Diane McLaughlin Vol #: 7
EC 1038 Ms. Judy Dahlgren Vol #: 7
EC 1039 Mrs. Joanna Dyson Vol #: 7
EC 1040 Mrs. Margaret Combs Vol #: 7
EC 1041 Ms. Lupita Volio Vol #: 7
EC 1042 Ms. suzan scal Vol #: 7
EC 1043 Mrs. Martha Ray Barger Vol #: 7
EC 1044 Miss. Becky Blechle Vol #: 7
EC 1045 Dr. Zoe Petropoulou Vol #: 7
EC 1046 Arbonne International Vol #: 7
EC 1047 Ms. Stephanie Winters Vol #: 7
EC 1048 Ms. Marilyn Saied Vol #: 7
EC 1049 Ms. Linda Rathburn Vol #: 7
EC 1050 Ms. Karen Philp Vol #: 7
EC 1051 Mrs. Carole Hargrove Vol #: 7
EC 1052 Ms. Lori LeBlanc Vol #: 7
EC 1053 Mrs. Dianna Fennessey Vol #: 7
EC 1054 Mr. Rodney King Vol #: 7
EC 1055 Mrs. fran long Vol #: 7
EC 1056 Mrs. nancy warner Vol #: 7
EC 1057 Ms. Laurie Murphy Vol #: 7
EC 1058 Arbonne Int'l Vol #: 7
EC 1059 Mrs. Myra Corbett Vol #: 7
EC 1060 individual Vol #: 7
EC 1061 Mrs. Linda Smith Vol #: 7
EC 1062 Mrs. Jennifer McMahon Vol #: 7
EC 1063 Mrs. Sherry Houwerzyl Vol #: 7
EC 1064 Mrs. Diane O'Brien Vol #: 7
EC 1065 Ms. Shirley Hart Vol #: 7
EC 1066 Mrs. yaffa tarlovsky Vol #: 7
EC 1067 Ms. Jamie Richards Vol #: 7
EC 1068 Mrs. Keri Saunders Vol #: 7
EC 1069 Ms. Helga E. Perez Vol #: 7
EC 1070 Ms. Beth Muehlenkamp Nateghi Vol #: 7
EC 1071 Arbonne Vol #: 7
EC 1072 Ms. Laura Bryant Vol #: 7
EC 1073 Ms. Barbara Peterson Vol #: 7
EC 1074 Ms. Melissa Gault Vol #: 7
EC 1075 Ms. shevaun merritt Vol #: 7
EC 1076 Mrs. Nancy Coats Vol #: 7
EC 1077 Mrs. Margaret Weber Vol #: 7
EC 1078 Mrs. Elena Obradovich Vol #: 7
EC 1079 Mrs. JoAnn Morris Vol #: 7
LET 1 J. Lorensen Vol #: 6
2005P-0459 To enforce ban on carbon monoxide gas in fresh meat packaging
RC 1 Kalsec Inc. Vol #: 2
2006N-0045 Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT); Public Workshop; Request for Comments
NM 1 FDA Vol #: 1

Page created on February 22, 2006 kk

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