DOCKETS ENTERED on 08/13/99

Docket Title

Number

77N-094W Analgestic/Antipyretic active ingredients for internal use

PDN 1 HFD-560 to Whitman, Breed, Abbott & Morg Vol#: 12

96P-0328 Modify 640.3(d) after 'Therapeutic Bleedings'

C 59 James W. Cassedy Vol#: 1

C 60 Gordon S. Hamilton Vol#: 1

C 61 George Coffin Vol#: 1

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

GDL 1 Guidance Vol#: 1

97P-0498 Label foods & beverages containing greater than 5mg caffeine

LET 5 HFS-165 to University of Vermont Vol#: 1

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 58 Kelli Wages Vol#: 2

C 59 Form letter count Vol#: 3

98H-0941 Civil Money Penalties;Gatchis Family Partners Inc,d/b/a Capi

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

98N-1215 Foreign Establishment Registration and Listing

EC 2 Acsion Industries, Inc. Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 5796 Glenn Kitzis Vol#: 168

C 5797 Polly Storing Vol#: 168

C 5798 Paula Frechen Vol#: 168

C 5799 Bob & Patty Moorhead Vol#: 168

C 5800 Elizabeth M. Nelson Vol#: 168

C 5801 Muriel Hoehne Vol#: 168

C 5802 Janet S. Gauerke Vol#: 168

C 5803 Joyce Reed Vol#: 168

C 5804 Eileen B. Wolfe Vol#: 168

C 5805 Kay Wollman Vol#: 168

C 5806 Charan E. Bacon Vol#: 168

C 5807 Virginia Maclovia Vol#: 168

C 5808 Carol Silagyi Vol#: 168

C 5809 Suzanne Last Vol#: 168

C 5810 Bonnie J. Cunningham Vol#: 168

C 5811 Doug & Margaret Ann Lindquist Vol#: 168

C 5812 Judith R. Vogel Vol#: 168

C 5813 S. Grenert Vol#: 168

C 5814 Tamara K. Aprati Vol#: 168

C 5815 Jo Ann Svoboda Vol#: 168

C 5816 Cecilia Di Somma Vol#: 168

C 5817 Martina L. Avery-Perry Vol#: 168

C 5818 Yolande Bavan Vol#: 168

C 5819 Elaine Barney Vol#: 168

C 5820 William L. Barney Vol#: 168

C 5821 Paula Farago Vol#: 168

C 5822 Cathy P. Massey Vol#: 168

C 5823 Elizabeth S. Murphy Vol#: 168

C 5824 Beth A. Nilsson Vol#: 168

C 5825 Barbara Simmons Vol#: 168

C 5826 Barbara S. Cohen Vol#: 168

C 5827 Lenore E. Urbanski Vol#: 168

C 5828 Sr Mary Jeannette Soran Vol#: 168

C 5829 Suzanne Kilkus Vol#: 168

C 5830 Gwendolyn Cates Vol#: 168

C 5831 Sharon W. Frazier Vol#: 168

C 5832 Nancy J. Fine Vol#: 168

C 5833 R. Allison Vol#: 168

C 5834 Dorothy Heard Vol#: 168

C 5835 Connie Swaiko Vol#: 168

C 5836 J. R. Dunster Vol#: 168

C 5837 Nina Bennas Vol#: 168

C 5838 Carol Gordner Vol#: 168

C 5839 Judith J. Pepper Vol#: 168

C 5840 Darlene Pinkowski Vol#: 168

C 5841 Joseph A. Prow Vol#: 168

C 5842 Dawn Leigh Vol#: 168

C 5843 Karen R. Olmedo Vol#: 168

C 5844 Jacqueline M. Smith Vol#: 168

C 5845 Julie J. Smeltzer Vol#: 168

C 5846 Roberta J. Minne Vol#: 168

C 5847 Vivian Kurz Vol#: 168

C 5848 Delorisa C. Thomas Vol#: 168

C 5849 Edith Berman Vol#: 168

C 5850 Ralph Kramer Vol#: 168

C 5851 Cecila M. Garrity Vol#: 168

C 5852 Doris E. Edwards Vol#: 168

C 5853 Karen B. Crystal Vol#: 168

C 5854 Nora Barron Vol#: 168

C 5855 Janet Van Bleskom Vol#: 168

C 5856 Karen Clark Vol#: 168

C 5857 Jane E. Cearlone Vol#: 168

C 5858 Linda B. Wolford Vol#: 168

C 5859 Joan Jungmeyer Vol#: 168

C 5860 Shyer L. Neveaux Vol#: 168

C 5861 Lori A. Hershberger Vol#: 168

C 5862 Nancy M. Azlle Vol#: 168

C 5863 Latina Esquell Vol#: 168

C 5864 Joan L. Lenhart Vol#: 168

C 5865 Deanne Rabbitt Vol#: 168

C 5866 Alayne S. Macaulay Vol#: 168

C 5867 Linda J. Hallman Vol#: 168

C 5868 Lorelei Flomenhoft Vol#: 168

C 5869 Ann M. Ours Vol#: 168

C 5870 Illegible Vol#: 168

C 5871 Cheryl Stevens Vol#: 168

C 5872 Sylvia O. Gustapor Vol#: 168

C 5873 Shyler L. Neveaux Vol#: 168

C 5874 Gail Morgan Vol#: 168

C 5875 Pauline MacLeod Vol#: 168

C 5876 Nancy H. Sisson Vol#: 168

C 5877 Sharon O. Sheltzer Vol#: 168

C 5878 Charles H. Talbott Vol#: 168

C 5879 Judith VanderZwaag Vol#: 168

C 5880 Alice Scott Vol#: 168

C 5881 Mary Coston Vol#: 168

C 5882 Johanna Effyland Vol#: 168

C 5883 Cathie A. Porath Vol#: 168

C 5884 Judy Powell Vol#: 168

C 5885 Jo Ann Austreng Vol#: 168

C 5886 Marlene Stieber Vol#: 168

C 5887 Nancy J. Springer Vol#: 168

C 5888 Marion P. Ogletree Vol#: 168

C 5889 Marianne C. Winters Vol#: 168

C 5890 Carolyn P. Shelburne Vol#: 168

C 5891 Pamela C. Schulten Vol#: 168

C 5892 Linda Marsek Vol#: 168

C 5893 J. L. Robinson Vol#: 168

C 5894 Barrie A. Montross Vol#: 168

C 5895 Patrycia Elliott Vol#: 168

C 5896 Laurie Z. Besch Vol#: 168

C 5897 Susan Puzio Vol#: 168

C 5898 Deborah Wolen Vol#: 168

C 5899 Selnea Mindes Vol#: 168

C 5900 Diane Arnone Vol#: 168

C 5901 Myrna R. Hood Vol#: 168

C 5902 Juliet J. Leeb Vol#: 168

C 5903 Caroline Carlson Vol#: 168

C 5904 Kathleen Swanson Vol#: 168

C 5905 Ellen Saraisky Vol#: 168

C 5906 Sally A. Krodel Vol#: 168

C 5907 Patricia A. Tomaso Vol#: 168

C 5908 Cheri Jones Vol#: 168

C 5909 Diana De Boer Vol#: 168

C 5910 Amy S. Okomoto Vol#: 168

C 5911 Linda Garrison Vol#: 168

C 5912 Frances W. Monson Vol#: 168

C 5913 Lynn Jeffrey Vol#: 168

C 5914 Doreen Freedner Vol#: 168

C 5915 Barbara D. Miller Vol#: 168

C 5916 Carole Dickson Vol#: 168

98P-1147 Prohibit use of xenotransplantation

LET 1 International Ctr for Technology Assessm Vol#: 2

99D-1149 In Vivo Pharmacokinetics & Bioavail Levothyroxine Sodium Tab

C 1 Knoll Pharmaceutical Company Vol#: 2

C 2 Knoll Pharmaceutical Company Vol#: 1

99H-2537 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2608 Civil Money Penalty;B&D Petroleum Sales Inc,dba AJI Industri

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2609 Civil Money Penalty;Cumberland Farms Inc,dba Cumberland Farm

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2610 Civil Money Penalty;Cross Roads Curb Market Inc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2611 Civil Money Penalty;Deborah Nored,dba Dixie Pig Country Stor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2612 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drugs #502

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2613 Civil Money Penalty;Food Lion Inc,dba Food Lion Store #690

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2614 Civil Money Penalty;Getty Petroleum Marketing Inc,dba Lakesi

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2615 civil Money Penalty;Ingles Markets Incorporated,dba Ingles #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2616 Civil Money Penalty;Jon Hanson & Wally Pettit,dba Tom Thumb

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2617 Civil Money Penalty;Joe LaCotts,dba 7-Eleven Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2618 Civil Money Penalty;McKinney's So-Lo Market Inc,dba McKinney

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2619 Civil Money Penalty;Olympic Oil Co Inc,dba Quik Shop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2620 Civil Money Penalty;Pat's 66 inc,dba Pat's 66

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2621 Civil Money Penalty;Rock Bottom Restaurants Inc,dba Old Chic

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2622 Civil Money Penalty;Robert Rabeaux,dba Rob's Corner Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2623 Civil Money Penalty;Rick Thomas,dba Lawson Super

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2624 Civil Money Penalty;Richard Brown,dba Brown's General Expres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2625 Civil Money Penalty;Tim Humbert Carol Humbert Billy Buck & B

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2626 Civil Money Penalty;USA Gasoline Corporation,dba USA Gas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2627 Civil Money Penalty;Wayne Langley,dba Diggins Quick Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2631 Civil Money Penalty;Tom's Chevron Inc,dba Chevron

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2632 Civil Money Penalty;Camp Oil Company,dba Sav-A-Ton

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2633 Civil Money Penalty;Kmart Corporation,dba Big K #3294

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-0193 Supplements and Other Changes to an Approved Application

C 3 USP, United States Pharmacopeia Vol#: 1

99N-1502 Quality Mammography Standards

OB 1 Dr. Geoffrey H. Smith Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1377 Dennis Winslow Vol#: 22

C 1378 Kevin M Marek Vol#: 22

C 1379 Kim Horsley DVM Vol#: 22

C 1380 Nancy Nichols Vol#: 22

C 1381 Sarah Winterholter Vol#: 22

C 1382 Maureen Nightingale Vol#: 22

C 1383 Charlie Crooks Vol#: 22

C 1384 James W Fallaw Vol#: 22

C 1385 Edwin Price Vol#: 22

C 1386 Karl Rysted Vol#: 22

C 1387 Dr David Schneider Vol#: 22

C 1388 John M Eastman Vol#: 22

C 1389 Janet Goldstein Vol#: 22

C 1390 Shannon M Speth Vol#: 22

C 1391 Beth Gunn PhD Vol#: 22

C 1392 Peter Doodeheefver Vol#: 22

C 1393 Shirley Sabbeth Vol#: 22

C 1394 Alan Elfanbaum Vol#: 22

C 1395 Leon Schwartz Vol#: 22

C 1396 Jan & Sally Van Niel Vol#: 22

C 1397 Osmond Molarsky Vol#: 22

C 1398 Daniel McKeighen Vol#: 22

C 1399 Dr L Kuby Vol#: 22

C 1400 Lisa M Tokarz Vol#: 22

C 1401 Elva Hunting Vol#: 22

C 1402 Howard & Bernadette Latin Vol#: 22

C 1403 Marquita K Hill PhD Vol#: 22

C 1404 Elizabeth A Rader Vol#: 22

C 1405 Sue D'Onofrio Vol#: 22

C 1406 Charles Bell Vol#: 22

C 1407 Macky Bennett Vol#: 22

C 1408 Kevin M Crupi Vol#: 22

C 1409 Renee Shur Vol#: 22

C 1410 Mary Story Vol#: 22

C 1411 Gene Weinshenker Vol#: 22

C 1412 George Profous Vol#: 22

99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone

RC 1 Roxane Laboratories, Inc. Vol#: 1

99P-2775 Refuse abbreviated new drug application for gabapentin tablt

ACK 1 HFA-305 Vol#: 1

CP 1 Palmer & Dodge Vol#: 1

99P-2776 ANDA proposed a dosage of Oxycodone & Acetaminophen Oral Sol

ACK 1 HFA-305 Vol#: 1

CP 1 King & Spalding Vol#: 1

99V-2774 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Space Productions Vol#: 1