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| Dockets Entered
On August 9, 2004
Table of Contents
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| Docket #
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| Title
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| 1985V-0284
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| Starlight series one laser light show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0610
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| Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2003N-0338
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| Obesity
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2003P-0479
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| Allow importation of Canadian versions of drugs that are approved to the United States
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| 2004N-0181
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| Critical Path Initiative
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| 2004P-0110
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| 2004P-0357
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| determination lthat an advisory opinion or exemption is not needed in accorance with FDA regulations
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| 2004P-0359
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| Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial
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| 2004S-0233
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| Stimulating Innovation in Medical Technologies
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| 2004V-0318
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| Laser Light Show
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| 2004V-0358
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| Projector for a Laser Light Show
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| 1985V-0284
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| Starlight series one laser light show
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| VRA
10
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| HFZ-300 to Starlasers
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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
14190
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14191
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14192
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14193
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| Enzymatic Therapy
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| Vol #:
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| 123
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| LET
14194
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| Enzymatic Therapy
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| Vol #:
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| 123
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| LET
14195
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| Enzymatic Therapy
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| Vol #:
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| 123
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| LET
14196
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| Enzymatic Therapy
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| Vol #:
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| 123
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| LET
14197
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| Enzymatic Therapy
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| Vol #:
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| 123
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| LET
14198
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| Enzymatic Therapy
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| Vol #:
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| 123
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| LET
14199
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| Inverness Medical Nutritionals Group
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| Vol #:
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| 123
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| LET
14200
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| Pure Encapsulations, Inc.
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| Vol #:
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| 123
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| LET
14201
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| Purdue Products L.P.
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| Vol #:
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| 123
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| LET
14202
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| Loders Croklaan Lipid Nutrition
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| Vol #:
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| 123
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| LET
14203
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| Loders Croklaan Lipid Nutrition
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| Vol #:
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| 123
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| LET
14204
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| Loders Croklaan Lipid Nutrition
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| Vol #:
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| 123
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| LET
14205
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| Loders Croklaan Lipid Nutrition
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| Vol #:
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| 123
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| LET
14206
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| Natural Factors Nutritional Products, Inc.
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| Vol #:
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| 123
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| LET
14207
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 123
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| LET
14208
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 123
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| LET
14209
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 123
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| LET
14210
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| Natural Factors Nutritional Products Inc.
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| Vol #:
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| 123
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| LET
14211
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14212
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14213
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14214
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14215
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14216
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14217
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14218
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14219
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14220
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14221
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14222
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14223
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14224
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14225
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| Perrigo Company of South Carolina
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| Vol #:
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| 123
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| LET
14226
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| Enzymatic Therapy
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| Vol #:
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| 123
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| 1998P-0610
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| Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
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| ANS
2
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| HFD-1 to Wellpoint
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| Vol #:
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| 6
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| C 56
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| N. Caplan
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| Vol #:
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| 2
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| C 57
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| R. Flygar
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| Vol #:
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| 2
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| C 58
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| D. Oder
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| Vol #:
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| 2
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 1876
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| Gilda De Ferrari
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| Vol #:
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| 281
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| SUP
8
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| Honeywell
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| Vol #:
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| 2
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| C
3
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| Hyman, Phelps & McNamara, PC
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| Vol #:
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| 3
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| 2003P-0479
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| Allow importation of Canadian versions of drugs that are approved to the United States
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| PDN
1
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| HF-22 to Honorable Charlie Ryan
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| Vol #:
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| 1
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| PDN
2
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| HF-22 to Sate of Vermont
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| Vol #:
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| 1
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| C
3
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| Assn for Dressings and Sauces (ADS)
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| Vol #:
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| 2
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| C
4
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| Alliance for Listeriosis Prevention (Alliance)
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| Vol #:
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| 2
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| C
5
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| National Frozen Pizza Institute (NFPI)
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| Vol #:
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| 2
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| SUP
2
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| Pfizer, Inc.
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| Vol #:
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| 3
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| 2004N-0181
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| Critical Path Initiative
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| C
50
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| United States Bone and Joint Decade (USBJD)
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| Vol #:
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| 3
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| C
51
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| Lymphoma Research Foundation
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| Vol #:
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| 3
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| C
52
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| Scleroderma Foundation
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| Vol #:
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| 3
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| C 53
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| W M Kelly
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| Vol #:
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| 3
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| C
54
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| National Coalition for Cancer Survivorship
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| Vol #:
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| 3
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| C
55
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| American Society of Clinical Oncology
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| Vol #:
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| 3
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| C
56
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| Prostate Cancer Foundation
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| Vol #:
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| 3
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| C 57
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| I Ross
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| Vol #:
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| 3
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| EMC 14
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| Number not used
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| Vol #:
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| 3
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| EMC
15
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| Johnson & Johnson
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| Vol #:
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| 3
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| EXT
2
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| American Frozen Food Institute
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| Vol #:
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| 1
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| EXT
1
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| China WTO/TBT
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| Vol #:
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| 2
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| C
13
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| Baker Commodities, Inc.
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| Vol #:
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| 7
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| C 14
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| Dr. M. Laderoute
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| Vol #:
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| 7
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| C
15
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| Pet Food Institute (PFI)
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| Vol #:
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| 7
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| C 16
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| M. Cornette
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| Vol #:
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| 7
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| C 17
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| C. Hughes
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| Vol #:
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| 7
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| C 18
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| S. Mellinger
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| Vol #:
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| 7
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| C 19
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| F. McKee
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| Vol #:
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| 7
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| C 20
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| Form Letters
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| Vol #:
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| 10
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| C 21
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| Form Letters
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| Vol #:
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| 11
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| EXT
20
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| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 7
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| LET
1
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| HF-11
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| Vol #:
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| 7
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| 2004P-0074
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| oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin
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| C
1
Tab
A, B, C
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| Heller Ehrman
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| Vol #:
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| 1
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| 2004P-0110
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| LET
4
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| Grocery Manufacturers of America (GMA)
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| Vol #:
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| 1
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| 2004P-0357
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| determination lthat an advisory opinion or exemption is not needed in accorance with FDA regulations
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| ACK 1
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| City of Arlington Texas
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| Vol #:
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| 1
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| AP
1
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| City of Arlington Texas
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| Vol #:
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| 1
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| 2004P-0359
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| Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial
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| ACK 1
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| HFA-305 to Methapharm Inc.
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| Vol #:
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| 1
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| CP
1
Attachment 1,
2
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| Methapharm Inc.
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| Vol #:
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| 1
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| 2004S-0233
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| Stimulating Innovation in Medical Technologies
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| C
2
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| American Assn for Clinical Chemistry (AACC)
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| Vol #:
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| 1
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| EC 5
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| American Academy of Orthopaedic Surgeons
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| Vol #:
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| 1
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| 2004V-0318
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| Laser Light Show
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| VRA
1
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| HFZ-300 to Sun on the Beach
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| Vol #:
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| 1
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| 2004V-0358
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| Projector for a Laser Light Show
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| ACK
1
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| HFA-305 to Guitar Center #220
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| Vol #:
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| 1
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| VAR
1
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| Guitar Center #220
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| Vol #:
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| 1
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