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Dockets Management

95S-0117  Human Drugs Patent Term Extension & New Patents

97S-0162  30-Day Structure Function Claim Notification Letters Dietary

00F-0792  OLESTRA BE AMENDED REMOVING REQUIREMENT FOR LABEL STATEMENT

00N-1571  Enrofloxacin for Poultry: Opportunity for Hearing

02D-0468  Manufacture and Labeling of Raw Meat Foods

02P-0163  Expedite Over-the-Counter Approval for Desloratidine

02P-0457  Selenium and Anticarcinogenic effects in certain cancers

02D-0526  Guidance for drug Chemistry, Manufacturing, Control Info.

03D-0001  Nonclinical Safety Evaluation of Pediatric Drug Products

03D-0061  Comparability Protocols Chemistry Manufacturing and controls

03P-0188  ANDA Suitability for Glyburide & Metformin HCl Tablets

88N-0038  Records & Reports concerning experience w/ new animal drugs

N   1                                                 Vol#: 1

95S-0117  Human Drugs Patent Term Extension & New Patents

LST 82      List as of April 30, 2003                 Vol#: 6

97S-0162  30-Day Structure Function Claim Notification Letters Dietary

LET 10279   PhytoPharmica Natural Medicines           Vol#: 77

LET 10280   Enzymatic Therapy Natural Medicines       Vol#: 77

LET 10281   Enzymatic Therapy Natural Medicines       Vol#: 77

LET 10282   NBTY, Inc.                                Vol#: 77

LET 10283   NBTY, Inc.                                Vol#: 77

LET 10284   Enzymatic Therapy Natural Medicines       Vol#: 77

LET 10285   Basic Research L.L.C.                     Vol#: 77

LET 10286   Basic Research L.L.C.                     Vol#: 77

LET 10287   Basic Research L.L.C.                     Vol#: 77

LET 10288   Basci Research, L.L.C.                    Vol#: 77

LET 10289   Basic Research, L.L.C.                    Vol#: 77

LET 10290   Basicc Research,L.L.C.                    Vol#: 77

LET 10291   Source Naturals                           Vol#: 77

LET 10292   Source Naturals                           Vol#: 77

LET 10293   Pulse Nutrition Solutions, Inc.           Vol#: 77

LET 10294   General Vitamin Corporation               Vol#: 77

LET 10295   RKS Inc.                                  Vol#: 77

LET 10296   Met-RX USA, Inc.                          Vol#: 77

LET 10297   Avon The Company for Women                Vol#: 77

LET 10298   Avon The Company for Women                Vol#: 77

LET 10299   Avon The Company for Women                Vol#: 77

LET 10300   Your Vitamins                             Vol#: 77

LET 10301   Your Vitamins                             Vol#: 77

LET 10302   Your Vitamins                             Vol#: 77

LET 10303   Your Vitamins                             Vol#: 77

LET 10304   PhytoPharmica Natural Medicines           Vol#: 77

LET 10305   Source Naturals                           Vol#: 77

LET 10306   RKS Inc.                                  Vol#: 77

LET 10307   Enzymatic Therapy Natural Medicines       Vol#: 77

LET 10308   Enzymatic Therapy Natural Medicines       Vol#: 77

LET 10309   Enzymatic Therapy Natural Medicines       Vol#: 77

LET 10310   Enzymatic Therapy Natural Medicines       Vol#: 77

LET 10311   Enzymatic Therapy Natural Medicines       Vol#: 77

LET 10312   Enzymatic Therapy Natural Medicines       Vol#: 77

LET 10313   Matol Botanical International Ltd.        Vol#: 77

LET 10314   Your Vitamins                             Vol#: 77

LET 10315   Your Vitamins                             Vol#: 77

LET 10316   Your Vitamins                             Vol#: 77

LET 10317   Twin Laboratories, Inc.                   Vol#: 77

LET 10318   Twin Laboratories, Inc.                   Vol#: 77

LET 10319   PhytoPharmica Natural Medicines           Vol#: 77

LET 10320   PhytoPharmica Natural Medicines           Vol#: 77

LET 10321   PhytoPharmica Natural Medicines           Vol#: 78

LET 10322   PhytoPharmica Natural Medicines           Vol#: 78

LET 10323   PhytoPharmica Natural Medicines           Vol#: 78

LET 10324   Enzymatic Therapy Natural Medicines       Vol#: 78

LET 10325   Natreon, Inc.                             Vol#: 78

LET 10326   Enzymatic Therapy Natural Medicines       Vol#: 78

LET 10327   Bio-Genics, Inc.                          Vol#: 78

LET 10328   Bio-Genics, Inc.                          Vol#: 78

LET 10329   Bio-Genisc, Inc.                          Vol#: 78

LET 10330   Bio-Genics, Inc.                          Vol#: 78

LET 10331   Bio-Genics, Inc.                          Vol#: 78

LET 10332   Bio-Genics, Inc.                          Vol#: 78

LET 10333   Bio-Genics, Inc.                          Vol#: 78

LET 10334   Bio-Genics, Inc.                          Vol#: 78

LET 10335   Bio-Genics, Inc.                          Vol#: 78

LET 10336   Bio-Genics, Inc.                          Vol#: 78

LET 10337   Bio-Genics, Inc.                          Vol#: 78

LET 10338   Bio-Genics, Inc.                          Vol#: 78

LET 10339   Bio-Genics, Inc.                          Vol#: 78

LET 10340   Bio-Genics, Inc.                          Vol#: 78

LET 10341   Bio-Genics, Inc.                          Vol#: 78

LET 10342   Bio-Genics, Inc.                          Vol#: 78

LET 10343   Bio-Genics, Inc.                          Vol#: 78

LET 10344   Bio-Genics, Inc.                          Vol#: 78

LET 10345   Bio-Genics, Inc.                          Vol#: 78

LET 10346   Bio-Genics, Inc.                          Vol#: 78

LET 10347   Bio-Genics, Inc.                          Vol#: 78

LET 10348   Bio-Genics, Inc.                          Vol#: 78

LET 10349   Enzymatic Therapy Natural Medicines       Vol#: 78

LET 10350   Enzymatic Therapy Natural Medicines       Vol#: 78

LET 10351   Enzymatic Therapy Natural Medicines       Vol#: 78

LET 10352   Enzymatic Therapy Natural Medicines       Vol#: 78

LET 10353   PhytoPharmica Natural Medicines           Vol#: 78

99N-4282  Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3981    Cornelia Goddin                           Vol#: 514

EMC 3982    Dawn M. H. Weberg                         Vol#: 514

EMC 3983    Brittany Smith                            Vol#: 514

EMC 3984    Gordon Gacek                              Vol#: 514

00F-0792  OLESTRA BE AMENDED REMOVING REQUIREMENT FOR LABEL STATEMENT

EMC 6       CSPI                                      Vol#: 10

00N-1571  Enrofloxacin for Poultry: Opportunity for Hearing

MO  45      Center for Veterinary Medicine            Vol#: 367

RMO 21      Bayer Corporation                         Vol#: 367

RMO 22      Bayer Corporation                         Vol#: 367

01P-0075  Switch Status of Emergency Contraceptives from Rx to OTC

EMC 303     Carl & julie Fichtner                     Vol#: 10

02D-0468  Manufacture and Labeling of Raw Meat Foods

EMC 7       Rebecca L. G. Verna, MS, DVM, CVCH        Vol#: 1

EMC 8       Lapdog Design, Inc.                       Vol#: 1

EMC 9       Mary Lynn Bushong                         Vol#: 1

EMC 10      Mary Lynn Bushong                         Vol#: 1

EMC 11      Karen Flocker                             Vol#: 1

EMC 12      Mary Giese                                Vol#: 1

EMC 13      Karen Flocker                             Vol#: 1

02D-0526  Guidance for drug Chemistry, Manufacturing, Control Info.

EMC 2       Dr. Paul G. King                          Vol#: 1

02H-0443  Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

CS  7       GCF-1                                     Vol#: 1

02N-0275  Bioterrorism Preparedness; Administrative Detention

NCR 1                                                 Vol#: 3

02N-0277  Bioterrorism; Establishment & Maintenance of Records

NCR 1                                                 Vol#: 4

02P-0163  Expedite Over-the-Counter Approval for Desloratidine

EMC 1       Citizen Outreach                          Vol#: 1

EMC 2       William Terry                             Vol#: 1

LET 2       HFD-240 to Citzen Outreach                Vol#: 1

02P-0168  Request better product labeling of sports & energy beverages

EMC 2       William Terry                             Vol#: 1

02P-0457  Selenium and Anticarcinogenic effects in certain cancers

LET 4       HFS-800 to Emord & Associates, PC         Vol#: 3

LET 5       HFS-800 to Emord & Associates, PC         Vol#: 3

LET 6       HFS-800 to Emord & Associates, PC         Vol#: 3

LET 7       Wellness Lifestyles, Inc.                 Vol#: 3

LET 8       HFS-800 to Emord & Associates, PC         Vol#: 3

LET 9       Wellness Lifestyles, Inc.                 Vol#: 3

MM  1       Between FDA & Emord & Associates, PC      Vol#: 3

PDN 1       HFS-800 to Emord & Associates, PC         Vol#: 3

03D-0001  Nonclinical Safety Evaluation of Pediatric Drug Products

C   7       Pfizer Inc.                               Vol#: 1

C   8       Abbott Laboratories                       Vol#: 1

03D-0061  Comparability Protocols Chemistry Manufacturing and controls

EMC 3       Dr. Paul G. King                          Vol#: 1

03N-0134  Team Biologics Program Effectiveness; Public Meeting

APE 18      FDA, ORA, OE                              Vol#: 1

APE 19      AnGes, Inc.                               Vol#: 1

APE 20      GlaxoSmithKline                           Vol#: 1

APE 21      IDEC Pharmaceuticals                      Vol#: 1

APE 22      FDA, OVRR/DBPAPs                          Vol#: 1

APE 23      DynPort Vaccine Company LLC               Vol#: 1

APE 24      PDA, Inc                                  Vol#: 1

APE 25      Novartis Pharmaceuticals Corporation      Vol#: 1

APE 26      National Hemophilia Foundation            Vol#: 1

APE 27      FDA, ORAHQ                                Vol#: 1

APE 28      AnGes, Inc.                               Vol#: 1

APE 29      FDA, Baltimore District                   Vol#: 1

APE 30      FDA, Regional Operations                  Vol#: 1

APE 31      Chiron Corporation                        Vol#: 1

APE 32      Sensitech                                 Vol#: 1

03P-0188  ANDA Suitability for Glyburide & Metformin HCl Tablets

ACK 1       HFA-305                                   Vol#: 1

CP  1       The Weinberg Group Inc.                   Vol#: 1

Page updated September 8, 2003 jb

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