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| Dockets Entered
On September 3, 2004
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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| 2002D-0320
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| Hold following clinical
investigator misconduct
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| 2003H-0432
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| Civil Money Penalty,
Korangy Radiology Associates, PA
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| 2003N-0455
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| Training Program for
Regulatory Project Managers; Information Available to Industry
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| 2003Q-0401
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| Qualified Health Claim
(QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
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| 2004E-0397
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| Patent Extension for
Prilosec OTC (omeprazole magnesium), U.S. Patent No. 5,817,338
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| 2004E-0398
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| Patent Extension for
IRESSA (gefitinib), U.S. Patent No. 5,770,599
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| 2004E-0399
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| Patent Extension for
Sensipar (cinacelet hydrochloride), U.S. Patent No. 6,313,146
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| 2004E-0402
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| Patent Extension for
AVASTIN (bevacizumab), U.S. Patent No. 6,054,297
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| 2004M-0387
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| P030010 - Siemens Mammomat
Novation Full Field Digital Mammography System,
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| 2004M-0388
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| P040012 - ACCULINK Carotid
Stent System and RX ACCULIN Carotid Stent System
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| 2004N-0214
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| Public Information Regulations
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| 2004N-0330
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| Suicidality in Clinical Trials
for Antidepressant Drugs in Pediatric Patients
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| 2004P-0365
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| Refrain from approving
ANDA for Agrylin (anagrelide hydrochloride) Capsules
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| 2004V-0400
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| Laser Light Show
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|
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| 1995S-0316
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| 75-Day Premarket
Notifications for New Dietary Ingredients
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| RPT
225
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| Rocky Mountain Selenium,
Inc
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| Vol #:
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| 163
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| RPT
226
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| Altai, LLC
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| Vol #:
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| 163
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| RPT
227
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| Outsource Product Manufacture
LLC
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| Vol #:
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| 163
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| RPT
228
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| Bioriginal Food &
Science Corporation
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| Vol #:
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| 164
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| RPT
229
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| Conseco Sea Buckthorn
Co., Ltd
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| Vol #:
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| 163
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| RPT
230
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| Conseco Sea Buckthorn
Co., Ltd
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| Vol #:
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| 163
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| RPT
231
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| Seven Tortoise Co.,
Ltd
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| Vol #:
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| 163
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| RPT
232
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| Omega Bio-Pharma (USA)
LLC
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| Vol #:
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| 163
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| 2002D-0320
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| Hold following clinical
investigator misconduct
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2003H-0432
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| Civil Money Penalty,
Korangy Radiology Associates, PA
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| CS
8
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| HFA-305 to Henry E.
Schwartz LLC
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| Vol #:
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| 4
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| OR
7
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| HF-3
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| Vol #:
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| 4
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| 2003N-0455
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| Training Program
for Regulatory Project Managers; Information Available to Industry
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2003Q-0401
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| Qualified Health
Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim
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| C
8
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| Unilever United States,
Inc.
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| Vol #:
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| 2
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| | | | | | | | |
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| LET
9
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| American Longevity Inc & Life Extension Foundation Buyers Club Inc
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| Vol #:
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| 2
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| LET
10
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| Martek Biosciences Corporation (Martek)
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| Vol #:
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| 2
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| 2004E-0397
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| Patent Extension for Prilosec OTC (omeprazole magnesium), U.S. Patent No. 5,817,338
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| APP
1
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| AstraZeneca AB
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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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| 2004E-0398
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| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
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| APP
1
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| AstraZeneca UK Limited
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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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| 2004E-0399
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| Patent Extension for Sensipar (cinacelet hydrochloride), U.S. Patent No. 6,313,146
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| APP
1
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| NPS Pharmaceuticals Inc. & The Brigham and Women's Hospital
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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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| 2004E-0402
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| Patent Extension for AVASTIN (bevacizumab), U.S. Patent No. 6,054,297
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| APP
1
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| Genentech, 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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| 2004M-0387
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| P030010 - Siemens Mammomat Novation Full Field Digital Mammography System,
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| AAV
1
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| Siemens Medical Solutions USA, Inc.
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| Vol #:
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| 1
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| 2004M-0388
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| P040012 - ACCULINK Carotid Stent System and RX ACCULIN Carotid Stent System
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| AAV
1
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| Guidant Corporation
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| Vol #:
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| 1
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| 2004N-0214
|
| Public Information Regulations
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|
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|
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0330
|
| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
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|
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| EC 19
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| Cardiff University
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| Vol #:
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| 1
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| EC 20
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| Cardiff University
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| Vol #:
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| 1
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| EC 21
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| Dr. Molly Hauck
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| Vol #:
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| 1
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|
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| 2004P-0365
|
| Refrain from approving ANDA for Agrylin (anagrelide hydrochloride) Capsules
|
|
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| PSA
1
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| Shire US, Inc.
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| Vol #:
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| 2
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|
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|
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| 2004V-0400
|
| Laser Light Show
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|
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| ACK 1
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| HFA-305 to Travis Hopkins
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| Vol #:
|
| 1
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|
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| VAR
1
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| Travis Hopkins
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| Vol #:
|
| 1
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