| | | | | | | | | | |
|
| |
|
| Dockets Entered
On October 6, 2003
Table of Contents
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| 2000N-1484
|
| Safety Reporting Requirements Human Drug/Biological Products
|
| |
|
|
| 2002E-0019
|
| Patent Term Application for Axert No. 5,565,447
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness;Registration of Food Facilities
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| 2003E-0037
|
| Patent Term Extension Application for LUMIGAN No. 5,688,819
|
| |
|
|
| 2003E-0081
|
| Patent Term Extension for ORTHO-EVRA No. 5,876,746
|
| |
|
|
| 2003E-0145
|
| Patent Term Extension Application for XIGRIS, No. 5,270,040
|
| |
|
|
| 2003E-0147
|
| Patent Extension Application for FROVA, No. 5,464,864
|
| |
|
|
| 2003E-0150
|
| Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
|
| |
|
|
| 2003E-0153
|
| Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
|
| |
|
|
| 2003E-0246
|
| Patent Extension for Deramaxx (deracoxib), 5,521,207,
|
| |
|
|
| 2003E-0248
|
| Patent Extension for Extranaeal (icodextrin), 4,761,237
|
| |
|
|
| 2003E-0250
|
| Patent Extension for Invanz (ertapenem sodium), 5,478,820
|
| |
|
|
| 2003E-0253
|
| Patent Extension for Lexapro (escitalopram oxalate), 34,712
|
| |
|
|
| 2003E-0261
|
| Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| 2003N-0136
|
| Adoption of FDA Food Code by Local,State,and Tribal Governme
|
| |
|
|
| 2003N-0404
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
|
| |
|
|
| 2003N-0421
|
| Determination That Trilafon Tablets and Three Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
|
| |
|
|
| 2003P-0090
|
| Removing Serzone (nefazodone) from the market Bristol-Myers
|
|
| |
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET
11118
|
| Green Earth Naturals
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11119
|
| Twin Laboratories Inc
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11120
|
| Twin Laboratories Inc
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11121
|
| CCA Industries, Inc.
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11122
|
| Enzymatic Therapy, Inc
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11123
|
| The Natural Bladder, LLC
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11124
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11125
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11126
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11127
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11128
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11129
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 85
|
|
| | | | | | | | |
|
| |
|
| LET
11130
|
| Pure Research Products Naturally LLC
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11131
|
| Chattem, Inc
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11132
|
| Chattem, Inc
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11133
|
| Tianshi Health Products, Inc
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11134
|
| Tianshi Health Products, Inc
|
| Vol #:
|
| 85
|
| |
|
|
| LET
11135
|
| Tabak's Health Products
|
| Vol #:
|
| 85
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C 7053
|
| Gigi Clark
|
| Vol #:
|
| 301
|
| |
|
|
| C 7054
|
| Phyllis J. Dzubinski
|
| Vol #:
|
| 301
|
| |
|
|
| C 7055
|
| Carol Sulanke
|
| Vol #:
|
| 301
|
| |
|
|
| C 7056
|
| Eva Vetter
|
| Vol #:
|
| 301
|
| |
|
|
| C 7057
|
| Darryl Miller
|
| Vol #:
|
| 301
|
| |
|
|
| C 7058
|
| No signature
|
| Vol #:
|
| 301
|
| |
|
|
| C 7059
|
| Mr & Mrs R.B. Caines
|
| Vol #:
|
| 301
|
| |
|
|
| C 7060
|
| Sheelagh M. Gatta
|
| Vol #:
|
| 301
|
| |
|
|
| C 7061
|
| A. Masonis
|
| Vol #:
|
| 301
|
| |
|
|
| 2000N-1484
|
| Safety Reporting Requirements Human Drug/Biological Products
|
| |
|
|
| C
8
|
| Bayer Pharmaceutical Corporation (Bayer)
|
| Vol #:
|
| 3
|
| |
|
|
| C
9
|
| Amersham Health
|
| Vol #:
|
| 3
|
| |
|
|
| 2002E-0019
|
| Patent Term Application for Axert No. 5,565,447
|
| |
|
|
| CEP
1
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness;Registration of Food Facilities
|
| |
|
|
| NM
2
|
| FDA
|
| Vol #:
|
| 13
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| NM
2
|
| FDA
|
| Vol #:
|
| 15
|
| |
|
|
| 2003E-0037
|
| Patent Term Extension Application for LUMIGAN No. 5,688,819
|
| |
|
|
| LET
2
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0081
|
| Patent Term Extension for ORTHO-EVRA No. 5,876,746
|
| |
|
|
| LET
2
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0145
|
| Patent Term Extension Application for XIGRIS, No. 5,270,040
|
| |
|
|
| LET
2
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0147
|
| Patent Extension Application for FROVA, No. 5,464,864
|
|
| | | | | | | | |
|
| |
|
| LET
3
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0150
|
| Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
|
| |
|
|
| LET
2
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0153
|
| Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
|
| |
|
|
| LET
2
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0246
|
| Patent Extension for Deramaxx (deracoxib), 5,521,207,
|
| |
|
|
| LET
2
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0248
|
| Patent Extension for Extranaeal (icodextrin), 4,761,237
|
| |
|
|
| LET
2
|
| Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0250
|
| Patent Extension for Invanz (ertapenem sodium), 5,478,820
|
| |
|
|
| LET
2
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0253
|
| Patent Extension for Lexapro (escitalopram oxalate), 34,712
|
| |
|
|
| LET
2
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003E-0261
|
| Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
|
| |
|
|
| LET
3
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| C
1
|
| American Bakers Assn (ABA)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0136
|
| Adoption of FDA Food Code by Local,State,and Tribal Governme
|
| |
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0404
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0421
|
| Determination That Trilafon Tablets and Three Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0090
|
| Removing Serzone (nefazodone) from the market Bristol-Myers
|
| |
|
|
| LET
1
|
| HFD-6 to Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
|
Page created on 10//07/03 kk
Page updatedc on 10/21/2003 jb
|
