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| Dockets Entered
On October 10, 2003
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2002N-0276
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| Bioterrorism Preparedness;Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2003M-0443
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| Premarket Approval, BP 010009/0, Cambridge Biotech HIV-1 Urine Western Blot
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| 2003M-0444
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| Premarket Approval, BP 010001/0, NucliSens HIV-1 QT
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| 2003M-0445
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| Premarket Approval, BP 000028/0, The VERSANT HIV-1 RNA 3.0 Assay (bDNA)
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| 2003M-0446
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| Premarket Approval, BP 010047/0, OraQuick Rapid HIV-1 Antibody Test
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| 2003M-0447
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| Premarket Approval, BP-020066/0, Vironstika HIV-1 Plus O Microelisa System
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0467
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| Risk Assessment for Food Terrorism and Other Food Safety Concerns; Availability
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| 2003P-0475
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| Drug Product containing hydrocodone bitartrate 5 mg and acetaminophen 325 mg in liquid form oral administration is suitable for evaluation under an ANDA
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| 2003P-0477
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| Expedite the revocation of determination of the application of the AIP
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| 2003V-0473
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| Variance Laser Display Device, JENOPTIK LOS: JenLas WHiteLight; Projector
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
11242
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| Wellness International Network, Ltd.
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| Vol #:
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| 85
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| LET
11243
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 85
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| LET
11244
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| Botanic Gardens, Inc.
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| Vol #:
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| 85
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| LET
11245
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| Botanic Gardens, Inc.
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| Vol #:
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| 85
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| LET
11246
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| Intelligent Nutrients, Inc.
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| Vol #:
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| 86
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| 1998N-1109
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| Mercury Compounds in Drugs and Food
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| EC 3
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| Renninger, Pamela
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| Vol #:
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| 2
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| 2002N-0276
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| Bioterrorism Preparedness;Registration of Food Facilities
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| NIR
1
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| FDA
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| Vol #:
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| 14
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| NIR
1
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| FDA
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| Vol #:
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| 16
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| 2003M-0443
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| Premarket Approval, BP 010009/0, Cambridge Biotech HIV-1 Urine Western Blot
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| AAV
1
SS&E,
Label
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| Calypte Biomedical Corporation
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| Vol #:
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| 1
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| 2003M-0444
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| Premarket Approval, BP 010001/0, NucliSens HIV-1 QT
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| AAV
1
SS&E,
Label
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| bioMerieux, Inc
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| Vol #:
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| 1
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| 2003M-0445
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| Premarket Approval, BP 000028/0, The VERSANT HIV-1 RNA 3.0 Assay (bDNA)
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| AAV
1
SS&E
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| Bayer Corporation
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| Vol #:
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| 1
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| 2003M-0446
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| Premarket Approval, BP 010047/0, OraQuick Rapid HIV-1 Antibody Test
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| AAV
1
SS&E,
Label
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| OraSure Technologies, Inc
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| Vol #:
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| 1
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| 2003M-0447
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| Premarket Approval, BP-020066/0, Vironstika HIV-1 Plus O Microelisa System
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| AAV
1
SS&E,
Label
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| bioMerieux, Inc.
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| Vol #:
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| 1
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| C
3
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| American Bakers Association
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| Vol #:
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| 2
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| C
4
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| Golden Foods LLC, Golden Brands, LLC
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| Vol #:
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| 2
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| C
5
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| National Food Processors Association
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| Vol #:
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| 2
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| C
6
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| Chocolate Manufacturers Association, National Confectioners Association
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| Vol #:
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| 2
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| C
7
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| Institute of Shortening and Edible Oils, Inc.
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| Vol #:
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| 2
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| EC 1
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| Wilkinson, Leah
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| Vol #:
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| 1
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| EC 2
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| Freeman, Robbin
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| Vol #:
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| 2
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| EC 3
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| Joseph, Stephen
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| Vol #:
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| 1
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| EC 4
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| Clark, Donald
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| Vol #:
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| 1
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| EC 5
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| Black, Richard
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| Vol #:
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| 1
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| EMC 53
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| Sean
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| Vol #:
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| 1
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| EMC 54
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| Jodi Marvin
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| Vol #:
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| 1
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| EMC 55
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| Jodi Marvin
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| Vol #:
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| 1
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| EMC
56
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| The Schwan Food Company
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| Vol #:
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| 1
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| EMC 57
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| Number not used
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| Vol #:
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| 1
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| EMC 58
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| Kevin Theroux
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| Vol #:
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| 1
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| EMC 59
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| Radpython
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| Vol #:
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| 1
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| EMC 60
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| Cindy and Gary Wilson
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| Vol #:
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| 1
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| EMC 61
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| wings
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| Vol #:
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| 1
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| EMC 62
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| Richard Hormaza
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| Vol #:
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| 1
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| EMC 63
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| Louis Corcoran
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| Vol #:
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| 1
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| EMC 64
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| Roger and Teryl Parker
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| Vol #:
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| 1
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| EMC 65
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| M M Fullwood
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| Vol #:
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| 1
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| EMC
66
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| Conagra Foods
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| Vol #:
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| 1
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| EMC 67
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| Mary Starks
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| Vol #:
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| 1
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| EMC 68
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| Mike Baucom
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| Vol #:
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| 1
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| EMC
69
Attachment
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| American Dietetic Association
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| Vol #:
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| 1
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| EMC
70
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| Snack Food Association
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| Vol #:
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| 1
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| EMC
71
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| BanTransFats.com
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| Vol #:
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| 2
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| EMC 72
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| Stepan Company
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| Vol #:
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| 2
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| EMC 73
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| Diana Schneider
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| Vol #:
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| 2
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| EMC
74
Attachment 1,
2
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| Federal Trade Commission
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| Vol #:
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| 2
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| EMC
75
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| Grocery Manufacturers of America
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| Vol #:
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| 2
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| EMC 76
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| John Vance
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| Vol #:
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| 3
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| EMC
77
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| General Mills
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| Vol #:
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| 3
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| EMC
78
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| BanTransFats.com
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| Vol #:
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| 3
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| EMC 79
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| Lori
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| Vol #:
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| 3
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| EMC 80
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| Lorraine Warren
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| Vol #:
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| 3
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| EMC 81
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| Sandy Varndell
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| Vol #:
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| 3
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| EMC 82
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| Sandy Varndell
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| Vol #:
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| 3
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| EMC 83
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| Eric Varndell, Sandy Varndell, Savannah Varndell, Clara Varndell
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| Vol #:
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| 3
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| EMC 84
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| Laila Selk
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| Vol #:
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| 3
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| EMC
85
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| ILSI North America
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| Vol #:
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| 3
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| EMC 86
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| Earl R Green, 1SG US Army (Ret)
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| Vol #:
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| 3
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| 2003N-0361
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| Anti-Counterfeit Drug Initiative
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| EC 3
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| Alperin, Jay
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| Vol #:
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| 2
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| EC 4
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| Robertson, Michael
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| Vol #:
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| 2
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| 2003N-0467
|
| Risk Assessment for Food Terrorism and Other Food Safety Concerns; Availability
|
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| N
1
|
| FDA
|
| Vol #:
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| 1
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| RA 1
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| BACKGROUND
|
| Vol #:
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| 1
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| 2003P-0475
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| Drug Product containing hydrocodone bitartrate 5 mg and acetaminophen 325 mg in liquid form oral administration is suitable for evaluation under an ANDA
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| ACK
1
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| HFA-305 to Internationa Regulatory Business Consultants, L.L.C.
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| Vol #:
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| 1
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| CP
1
Attachment
1, 2, 3,
4, 5
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| International Regulatory Business Consultants, Ltd.
|
| Vol #:
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| 1
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| 2003P-0477
|
| Expedite the revocation of determination of the application of the AIP
|
| |
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| ACK 1
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| HFA-305 to ENDOTEC
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| Vol #:
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| 1
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| CP
1
Attachment
A, B,
C,
D,
E, F
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| Endotec
|
| Vol #:
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| 1
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| 2003V-0473
|
| Variance Laser Display Device, JENOPTIK LOS: JenLas WHiteLight; Projector
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| ACK 1
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| HFA-305 to Carl Zeiss Jena GMBH
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| Vol #:
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| 1
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| VAR 1
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| Carl Zeiss Jena GMBH
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| Vol #:
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| 1
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