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| Dockets Entered
On September 27, 2005
Table of Contents
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| Docket #
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| Title
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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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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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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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-0333
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| Emergency Use Authorization of Medical Products
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2005M-0378
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| P930014/S015 - ACRYSOF Toric Posterior Chamber Intraocular Lens, Approved 9/14/05
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| 2005M-0379
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| P040037 - GORE VIABAHN Endoprosthesis, Approved 6/14/05
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| 2005M-0380
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| P030036 - SelectSecure Lead Model 3830, Approved 8/3/05
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| 2005M-0381
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| P040038 - Xact Carotid Stent System, Approved 9/6/05
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| 2005M-0382
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| P930016/S021 - STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan WaveFront System, Approved 8/30/05
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| 2005M-0387
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| P040005 - DakoCytomation Her2 FISH pharmDx Kit, Approved 5/3/05
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| 2005M-0388
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| P040011 - DakoCytomation c-Kit pharmDx, Approved 6/27/05
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005P-0139
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| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0325
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| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
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| 2005P-0398
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| ANDA Suitability for Carboplatin Injection, 10 mg/mL in a 1000 mg/100 mL multiple-dose vial
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| 2005P-0400
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| permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1286
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| L Fenton
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| Vol #:
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| 6
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| EMC 1287
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| K Paul
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| Vol #:
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| 6
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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 1120
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| J Perrey
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| Vol #:
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| 11
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| EMC 1121
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| E Limas
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| Vol #:
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| 11
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| SUP
2
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| Aventis Pharmaceuticals, Inc.
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| Vol #:
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| 3
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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
12
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| Center for Science in the Public Interest
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| Vol #:
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| 2
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| C
4
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| Elusys Therapeutics Inc
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EMC 1565
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| M Burns
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| Vol #:
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| 22
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS 16
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| HFA-305
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| Vol #:
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| 2
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| LET 6
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| Ecumed Health Group and Amador Reyes, et al
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| Vol #:
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| 2
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| LET 7
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| Ecumed Health Group andJuan C. Carrai , et al
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| Vol #:
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| 2
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| LET 8
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| GCF-1 to Ecumed Group and Amador Reyes, Juan C. Carrai, and Richard W. Stone, M.D.
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| Vol #:
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| 2
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| OR 15
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| HF-3 to Ecumed Health Group, and Amador Reyes, Juan C. Carrai, and Richard W. Stone, M.D.
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| Vol #:
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| 2
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| 2005M-0378
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| P930014/S015 - ACRYSOF Toric Posterior Chamber Intraocular Lens, Approved 9/14/05
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| AAV
1
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| Alcon Research Ltd.
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| Vol #:
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| 1
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| 2005M-0379
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| P040037 - GORE VIABAHN Endoprosthesis, Approved 6/14/05
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| AAV
1
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| W.L. Gore & Associates, Inc.
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| Vol #:
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| 1
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| 2005M-0380
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| P030036 - SelectSecure Lead Model 3830, Approved 8/3/05
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| AAV
1
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| Medtronic, Inc.
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| Vol #:
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| 1
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| 2005M-0381
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| P040038 - Xact Carotid Stent System, Approved 9/6/05
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| AAV
1
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| Abbott Vascular Devices
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| Vol #:
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| 1
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| 2005M-0382
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| P930016/S021 - STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan WaveFront System, Approved 8/30/05
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| AAV
1
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| VISX, Inc.
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| Vol #:
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| 1
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| 2005M-0387
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| P040005 - DakoCytomation Her2 FISH pharmDx Kit, Approved 5/3/05
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| AAV
1
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| DakoCytomation Denmark A/S
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| Vol #:
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| 1
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| 2005M-0388
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| P040011 - DakoCytomation c-Kit pharmDx, Approved 6/27/05
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| AAV
1
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| DakoCytomation California, Inc.
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| C 632
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| No Signature
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| Vol #:
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| 22
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| C 633
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| S Smith
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| Vol #:
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| 22
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| C 634
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| C Crocker
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| Vol #:
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| 22
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| C 635
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| M Gardenswartz
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| Vol #:
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| 22
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| C 636
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| H Zeiner
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| Vol #:
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| 22
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| C 637
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| G Christensen
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| Vol #:
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| 22
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| C 638
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| I Horabowy
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| Vol #:
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| 22
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| C 639
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| T E Post
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| Vol #:
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| 22
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| EC
96
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| NYU School of Medicine, Dept. of Anesthesiology
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| Vol #:
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| 2
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| EC
97
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| Edward Hospital
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| Vol #:
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| 2
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| EC
98
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| First Colonies Anesthesia Associates
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| Vol #:
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| 2
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| EMC 1
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| N Trombino
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| Vol #:
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| 2
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| 2005P-0325
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| Request Commissioner of Food and Drugs to amend its regulations related to sugar and alternative sweeteners
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| EC 2
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| Mr. Benjamin Cooper
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| Vol #:
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| 2
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| 2005P-0398
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| ANDA Suitability for Carboplatin Injection, 10 mg/mL in a 1000 mg/100 mL multiple-dose vial
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| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2005P-0400
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| permission to Donna Ricks to contine using Palladone for severe chronic pain due to stage 4 metastic breast cancer
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| CP 1
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| Donna Ricks
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| Vol #:
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| 1
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