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| Dockets Entered
On June 15, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2002N-0534
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| Medical Device User Fee and Modernization Act of 2002
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| 2003N-0161
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| Medical Devices;Reprocessed Single-Use Devices;Termination
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| 2005E-0233
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| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
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| 2005E-0234
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| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
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| 2005E-0235
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| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
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| 2005E-0236
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| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,912,246
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| 2005P-0212
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| ANDA suitability petition for Lamotrigine 50 milligram and 250 milligram oral tablets
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| 2005P-0232
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| Baby Chamonile Juice, 100% natural juice,containing chamomile flowers and filtered baby water
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
271
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| Biocodex, Inc
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| Vol #:
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| 203
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| RPT
272
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| Enzymotec Ltd
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| Vol #:
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| 204
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| RPT 273
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| Technology Commercializatoin Corp
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| Vol #:
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| 209
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16195
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| Enzymatic Therapy
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| Vol #:
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| 143
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| LET
16196
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| Natrol, Inc.
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| Vol #:
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| 143
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| LET
16197
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| Bayer HealthCare Consumer Care Division
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| Vol #:
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| 143
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| LET 16198
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET 16199
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET 16200
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| Source Naturals
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| Vol #:
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| 144
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| LET 16201
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| Dolisos American, Inc.
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| Vol #:
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| 144
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| LET 16202
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET 16203
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET 16204
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET 16205
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| LET 16206
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| Perrigo Company of South Carolina
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| Vol #:
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| 144
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18231
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| A. B. Bartholmew
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| Vol #:
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| 516
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| C 18232
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| S. E. Pedlow
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| Vol #:
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| 516
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| 2002N-0534
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| Medical Device User Fee and Modernization Act of 2002
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| C
40
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| AdvaMed
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| Vol #:
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| 2
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| 2003N-0161
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| Medical Devices;Reprocessed Single-Use Devices;Termination
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| C
6
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| AdvaMed
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| Vol #:
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| C
41
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| The Association for Dressing and Sauces
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| Vol #:
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| 4
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| C
42
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| Food Products Association
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| Vol #:
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| 4
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| NCD
1
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| FDA
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| Vol #:
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| 1
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| C
103
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| Bariatric Weight Loss Center
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| Vol #:
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| 9
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| C
5
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| AstraZeneca
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| Vol #:
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| 2
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| 2005E-0233
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| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
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| APP
1
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| Harald Breivik et al.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2005E-0234
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| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
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| APP
1
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| Gilead Sciences, Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2005E-0235
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| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
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| APP
1
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| Yamanouchi Pharmaceutical Co., Ltd
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2005E-0236
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| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,912,246
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| APP
1
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| Bracco International B.V.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2005P-0212
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| ANDA suitability petition for Lamotrigine 50 milligram and 250 milligram oral tablets
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| WDL
1
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| Pharmaceutical Patent Attorneys
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| Vol #:
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| 1
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| 2005P-0232
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| Baby Chamonile Juice, 100% natural juice,containing chamomile flowers and filtered baby water
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