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| Dockets Entered
On January 6, 2004
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1978N-0227
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| Trimethobenzamide Hydrochloride Injection & Capsules
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| 1987V-0401
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| Laser lighting effects
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| 1991P-0051
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| Adopt a Regulation to Codify the Name 'Cooking Wine'
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2001P-0290
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| Definition for the term 'stone ground' for wheat flour
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2003D-0163
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| Blood Product Safety in Cases of Suspected SARS,Severe Acute
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| 2003M-0442
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| Premarket Approval, BP 000009/0, Calypte HIV-1 Urine EIA
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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-0232
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| Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887
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| 2003N-0338
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| Obesity
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| 2003P-0292
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| Permit ANDA for a Ceftazidime for Injection,UPS,phamacy bulk package in a 100 gram dosage strength packaged in plastic bags that are contained within foil outer wraps
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| 2003P-0388
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| ANDA Suitability for Metformin Hydrochloride Extended-Release (XR) Tablets, 1000 mg
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| 2003V-0541
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| Laser Light Show
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| 2003V-0543
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| A Projector for a Laser Light Show
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| 1978N-0036L
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| OTC Laxative
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| LET
203
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| HFD-560 to Sonnenschein Nath & Rosenthal
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| Vol #:
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| 121
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| 1978N-0227
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| Trimethobenzamide Hydrochloride Injection & Capsules
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| PDN
1
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| HFC-1 to ETHEX Corporation
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| Vol #:
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| 1
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| 1987V-0401
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| Laser lighting effects
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| VRA
8
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| HFV-300 to Chameleon Productions
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| Vol #:
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| 1
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| 1991P-0051
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| Adopt a Regulation to Codify the Name 'Cooking Wine'
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| MT
1
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| HFS-822 and Olsson, Frank and Weeda, PC
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
12126
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| Integrative Therapeutics Inc.
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| Vol #:
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| 97
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| LET
12127
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| Integrative Therapeutics Inc.
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| Vol #:
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| 97
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| LET
12128
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| Integrative Therapeutics Inc.
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| Vol #:
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| 97
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| LET
12129
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12130
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12131
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12132
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12133
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12134
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12135
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12136
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12137
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12138
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12139
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12140
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12141
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12142
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12143
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12144
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12145
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12146
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12147
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12148
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12149
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| LET
12150
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| Weider Nutrition International Inc.
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| Vol #:
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| 97
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| 2001P-0290
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| Definition for the term 'stone ground' for wheat flour
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| PDN 2
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| HFC-1 to Hodgson Mill
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| Vol #:
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| 1
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| C
214
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| International Dioxcide, Inc
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| Vol #:
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| 20
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| 2003D-0163
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| Blood Product Safety in Cases of Suspected SARS,Severe Acute
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| EMC
1
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| American Assn of Blood Banks (AABB)
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| Vol #:
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| 1
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| 2003M-0442
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| Premarket Approval, BP 000009/0, Calypte HIV-1 Urine EIA
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| N
1
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| FDA
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| Vol #:
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| 1
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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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| N
1
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| FDA
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| Vol #:
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| 1
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| | | | | | | | |
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| 2003M-0444
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| Premarket Approval, BP 010001/0, NucliSens HIV-1 QT
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| N
1
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| FDA
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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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| N
1
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| FDA
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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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| N
1
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| FDA
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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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| N
1
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| FDA
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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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| EMC 110
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| C. Dreslough
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| Vol #:
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| 3
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| EMC 111
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| D. Nellis
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| Vol #:
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| 3
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| EMC 112
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| J. O'Leary
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| Vol #:
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| 3
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| EMC 113
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| R. Young
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| Vol #:
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| 3
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| EMC 114
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| M. Kophamer
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| Vol #:
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| 3
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| EMC 115
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| L. Mandela
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| Vol #:
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| 3
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| EMC 116
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| J. Shearer
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| Vol #:
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| 3
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| EMC 117
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| A. Toris
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| Vol #:
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| 3
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| EMC 118
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| B. McCarthy
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| Vol #:
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| 3
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| EMC 119
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| A. Tudose
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| Vol #:
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| 3
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| EMC 120
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| No signature
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| Vol #:
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| 3
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| EMC 121
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| J. Chonko
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| Vol #:
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| 3
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| 2003N-0232
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| Universal Reagents, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0887
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| WDL
1
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| Universal Reagents Inc
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| Vol #:
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| 1
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| 2003N-0338
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| Obesity
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| C
16
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| United States Senate
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| Vol #:
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| 10
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| TS
18
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| NIH Division of Nutrtion Research Coordination
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| Vol #:
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| 10
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| TS
19
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| NHLBI Obesity Eduction Initiative
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| Vol #:
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| 10
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| TS
20
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| DHHS-Office of Disease Prevention and Health Promotion
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| Vol #:
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| 10
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| 2003P-0274
|
| In re Tier 1 initial Approval Program
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| EMC 37
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| S.V. Minkus
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| Vol #:
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| 4
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| 2003P-0292
|
| Permit ANDA for a Ceftazidime for Injection,UPS,phamacy bulk package in a 100 gram dosage strength packaged in plastic bags that are contained within foil outer wraps
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| PAV 1
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| HFD-600 to Samson Medical Technologies LLC
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| Vol #:
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| 1
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