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| Dockets Entered
On March 27, 2006
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic 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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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004P-0457
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| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
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| |
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| |
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| 2005M-0399
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| P020016 - Total Temporomandibular Joint Replacement System, Approved 9/21/05
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| 2005M-0435
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| P960040/S028 - VENTAK PRIZM AVT AICD System, Approved 3/27/03
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| 2005M-0454
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| P980022/S011 - Guardian RT
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| |
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| 2005M-0473
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| P040003 - ExAblate 2000 System, Approved 10/22/04
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| |
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| 2005M-0474
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| P040013 - GEM 21S (Growth-factor Enhanced Matrix), Approved 11/18/05
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| |
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| 2005M-0475
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| P020045 - 7F Freezor Cardiac CryoAblation Catheter and CCT.2 CryoConsole System, Approved 4/17/03
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| |
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| 2005M-0476
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| P040042 - Therapy Dual 8 Cardiac Ablation System, Approved 11/18/05
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| 2005M-0477
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| P040047 -Coaptite, Approved 11/10/05
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| 2005M-0478
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| P030056 - ADVIA Centaur HCV ReadyPack Reagents and ADVIA Centaur HCV Quality Control Materials, Approved December 22, 2004
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| 2005M-0492
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| P030054/S010 - Epic and Atlas + HF CRT-D Systems
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| 2005M-0504
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| P040045 - VISTAKON (senofilcon A) Contact Lens, Clear and Visibility Tinted with UV Blocker, Approved 12/20/05
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| |
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| 2005N-0285
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| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006P-0129
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| to reclassify phenylpropanolamine(PPA) wieght control drug product from category I to category II
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| 2006P-0131
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| Make a determination that Epirubicin Hydrochloride Injection, 2mg/ miin vialsizes of 10 mg/ 5 mi, 20 mg/ 10 mi and 200 mg/ 100 mi are suitable for submission in an ANDA.
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| 2006P-0135
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| Issue Guidance to Industry outlining procedures and standards for initiating an "expanded access program" for unapproved drugs
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| 2006V-0134
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| Laser Light Show
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| 1976N-0052N
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| OTC Nasal Decongestants
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| ACK 9
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| Wyeth
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| Vol #:
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| 1
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| C 245
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| Block Drug Company (Block)
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| Vol #:
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| 77
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| C 246
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| GlaxoSmithKline Consumer Healthcare, LP (GSK)
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| Vol #:
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| 77
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| C 247
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| Wyeth Consumer Healthcare
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| Vol #:
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| 77
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| | | | | | | | |
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| CP 19
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| Wyeth
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| Vol #:
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| 86
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| CP 20
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| Wyeth
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| Vol #:
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| 98
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4390
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| R. Artley
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| Vol #:
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| 319
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| EMC 4391
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| C. Patterson
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| Vol #:
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| 319
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| EMC 4392
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| Rossi Family
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| Vol #:
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| 319
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| EMC 4393
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| M. Hermann
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| Vol #:
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| 319
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| EMC 4394
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| H. Hembrey
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| Vol #:
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| 319
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| EMC 20
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| D. Plumb
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| Vol #:
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| 3
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| |
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| EMC 635
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| R. Goodrich
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| Vol #:
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| 24
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 242
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| K. Starling
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| Vol #:
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| 4
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| |
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|
| EMC 617
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| Mission Possible International
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| Vol #:
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| 9
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| |
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| EMC 618
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 619
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| Mission Possible International
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| Vol #:
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| 9
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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 1254
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| K. Kimball
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| Vol #:
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| 12
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| EMC 1255
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| No signature
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| Vol #:
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| 12
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS 22
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| HFA-305
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| Vol #:
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| 10
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| OR 19
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| HF-3 to Ecumed Health Group, Amador Reyes, Juan Carrai, Richard W. Stone, & Erlinda E. Enrique
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| Vol #:
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| 10
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| 2004P-0457
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| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
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| ACK 2
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| HFA-305 to Endotec, Inc.
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| Vol #:
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| 5
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| CCP 2
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| Endotec, Inc.
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| Vol #:
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| 5
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| EMC 2
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| Japan Society of Pharmaceutical Machinery and Engineering (JSPME)
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| |
|
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| CS 7
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| HFA-305
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| Vol #:
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| 3
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| |
|
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| OR 7
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| HF-3 TO TMJ Implants, Inc. and Robert W. Christensen and Maureen K Mooney
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| Vol #:
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| 3
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| |
|
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| 2005M-0399
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| P020016 - Total Temporomandibular Joint Replacement System, Approved 9/21/05
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| |
|
|
| NAL 1
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| FDA
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| Vol #:
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| 1
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| |
|
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| 2005M-0435
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| P960040/S028 - VENTAK PRIZM AVT AICD System, Approved 3/27/03
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| |
|
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| NAL 1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 2005M-0454
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| P980022/S011 - Guardian RT
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| |
|
|
| NAL 1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 2005M-0473
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| P040003 - ExAblate 2000 System, Approved 10/22/04
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| |
|
|
| NAL 1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 2005M-0474
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| P040013 - GEM 21S (Growth-factor Enhanced Matrix), Approved 11/18/05
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| |
|
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| NAL 1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 2005M-0475
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| P020045 - 7F Freezor Cardiac CryoAblation Catheter and CCT.2 CryoConsole System, Approved 4/17/03
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| |
|
|
| NAL 1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 2005M-0476
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| P040042 - Therapy Dual 8 Cardiac Ablation System, Approved 11/18/05
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|
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| NAL 1
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| FDA
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| Vol #:
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| 1
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|
| |
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| 2005M-0477
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| P040047 -Coaptite, Approved 11/10/05
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| |
|
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| NAL 1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 2005M-0478
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| P030056 - ADVIA Centaur HCV ReadyPack Reagents and ADVIA Centaur HCV Quality Control Materials, Approved December 22, 2004
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| |
|
|
| NAL 1
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| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2005M-0492
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| P030054/S010 - Epic and Atlas + HF CRT-D Systems
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| |
|
|
| NAL 1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 2005M-0504
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| P040045 - VISTAKON (senofilcon A) Contact Lens, Clear and Visibility Tinted with UV Blocker, Approved 12/20/05
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| |
|
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| NAL 1
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| FDA
|
| 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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| |
|
|
| EMC 300
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| F. Thacker
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| Vol #:
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| 23
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| |
|
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| EMC 301
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| Gluten Free Oats, LLC (GFO)
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| Vol #:
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| 23
|
| |
|
|
| 2005N-0285
|
| Current Good Manufacturing Practice Regulation and Investigational New Drugs
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|
| | | | | | | | |
|
| |
|
| EMC 4
|
| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
|
| |
|
|
| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
|
|
| C 4110
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| L. Mayton
|
| Vol #:
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| 68
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| |
|
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| C 4111
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| B. Phillips, MD
|
| Vol #:
|
| 68
|
| |
|
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| C 4112
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| S. Benson
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| Vol #:
|
| 68
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| |
|
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| C 4113
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| C. Wimberg
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| Vol #:
|
| 68
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| |
|
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| C 4114
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| S. Pennington
|
| Vol #:
|
| 68
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| |
|
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| C 4115
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| J. Robertson
|
| Vol #:
|
| 68
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| |
|
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| C 4116
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| F. Turley
|
| Vol #:
|
| 68
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| |
|
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| C 4117
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| M. Thomas
|
| Vol #:
|
| 68
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| |
|
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| C 4118
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| J. Werbinski, MD
|
| Vol #:
|
| 68
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| |
|
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| C 4119
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| C. Kurtz, MD
|
| Vol #:
|
| 68
|
| |
|
|
| C 4120
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| J. Werbinski, MD
|
| Vol #:
|
| 68
|
| |
|
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| C 4121
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| J. Mullins
|
| Vol #:
|
| 68
|
| |
|
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| C 4122
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| O. Whiddon
|
| Vol #:
|
| 68
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| |
|
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| C 4123
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| C. Barlow, MD
|
| Vol #:
|
| 68
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| |
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| C 4124
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| R. Erickson, MD, FAAFP
|
| Vol #:
|
| 68
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| |
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| C 4125
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| S. Fahrbach
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| Vol #:
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| 68
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| |
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| C 4126
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| J. Thomspon
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| Vol #:
|
| 68
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| |
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| C 4127
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| C. Carlson
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| Vol #:
|
| 68
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| |
|
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| C 4128
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| L. Wehr
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| Vol #:
|
| 68
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| |
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| C 4129
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| K. Way
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| Vol #:
|
| 68
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| |
|
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| C 4130
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| K. Stilwell
|
| Vol #:
|
| 68
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| |
|
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| C 4131
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| P. Hindeiberger, MD, PhD
|
| Vol #:
|
| 68
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| |
|
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| C 4132
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| Dr. D. Jacoby
|
| Vol #:
|
| 68
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| |
|
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| C 4133
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| J. Newfeld
|
| Vol #:
|
| 68
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| |
|
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| C 4134
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| M. Toth
|
| Vol #:
|
| 68
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| |
|
|
| C 4135
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| L. Kenieczko
|
| Vol #:
|
| 68
|
| |
|
|
| C 4136
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| Dr. E. Simhbee
|
| Vol #:
|
| 68
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| |
|
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| C 4137
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| E. Miller
|
| Vol #:
|
| 68
|
| |
|
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| C 4138
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| J. Sievers
|
| Vol #:
|
| 68
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| |
|
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| C 4139
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| J. Schultz
|
| Vol #:
|
| 68
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| |
|
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| C 4140
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| M. Rodriguez
|
| Vol #:
|
| 68
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| |
|
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| C 4141
|
| S. Sass
|
| Vol #:
|
| 68
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| |
|
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| C 4142
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| J. Tester
|
| Vol #:
|
| 68
|
| |
|
|
| C 4143
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| C. Condit
|
| Vol #:
|
| 68
|
|
| | | | | | | |
|
| |
|
| C 4144
|
| M. Galvin
|
| Vol #:
|
| 68
|
| |
|
|
| C 4145
|
| D. Stefko
|
| Vol #:
|
| 68
|
| |
|
|
| C 4146
|
| F. Peterson
|
| Vol #:
|
| 68
|
| |
|
|
| C 4147
|
| J. Jaime
|
| Vol #:
|
| 68
|
| |
|
|
| C 4148
|
| C. Nichols
|
| Vol #:
|
| 68
|
| |
|
|
| C 4149
|
| S. Monaghan
|
| Vol #:
|
| 68
|
| |
|
|
| C 4150
|
| K. Treiber
|
| Vol #:
|
| 68
|
| |
|
|
| C 4151
|
| S. LaRosa
|
| Vol #:
|
| 68
|
| |
|
|
| C 4152
|
| R. Ferrara
|
| Vol #:
|
| 68
|
| |
|
|
| C 4153
|
| G. Fatum
|
| Vol #:
|
| 68
|
| |
|
|
| C 4154
|
| D. Chateauvert
|
| Vol #:
|
| 68
|
| |
|
|
| C 4155
|
| D. McIver
|
| Vol #:
|
| 68
|
| |
|
|
| C 4156
|
| K. Barton
|
| Vol #:
|
| 68
|
| |
|
|
| C 4157
|
| E. Bauer
|
| Vol #:
|
| 68
|
| |
|
|
| C 4158
|
| M. Reule
|
| Vol #:
|
| 68
|
| |
|
|
| C 4159
|
| S. Ware
|
| Vol #:
|
| 68
|
| |
|
|
| C 4160
|
| S. Rozier
|
| Vol #:
|
| 68
|
| |
|
|
| C 4161
|
| C. Curtis
|
| Vol #:
|
| 68
|
| |
|
|
| C 4162
|
| E. Skarbrevik
|
| Vol #:
|
| 68
|
| |
|
|
| C 4163
|
| L. LaCava
|
| Vol #:
|
| 68
|
| |
|
|
| C 4164
|
| J. Elliott
|
| Vol #:
|
| 68
|
| |
|
|
| C 4165
|
| M. Anderson
|
| Vol #:
|
| 68
|
| |
|
|
| C 4166
|
| F. Bacchelte
|
| Vol #:
|
| 68
|
| |
|
|
| C 4167
|
| S. Ruth
|
| Vol #:
|
| 68
|
| |
|
|
| C 4168
|
| L. Rechter
|
| Vol #:
|
| 68
|
| |
|
|
| C 4169
|
| J. Feddern
|
| Vol #:
|
| 68
|
| |
|
|
| C 4170
|
| B. Jackson-Davis
|
| Vol #:
|
| 68
|
| |
|
|
| C 4171
|
| D. Dorste
|
| Vol #:
|
| 68
|
| |
|
|
| C 4172
|
| M. Zepp
|
| Vol #:
|
| 68
|
| |
|
|
| C 4173
|
| M. Bacon
|
| Vol #:
|
| 68
|
| |
|
|
| C 4174
|
| B. Bieder
|
| Vol #:
|
| 68
|
| |
|
|
| C 4175
|
| M. Posner
|
| Vol #:
|
| 68
|
| |
|
|
| C 4176
|
| Y. Chapa
|
| Vol #:
|
| 68
|
| |
|
|
| C 4177
|
| N. Koehler
|
| Vol #:
|
| 68
|
| |
|
|
| C 4178
|
| S. Cook
|
| Vol #:
|
| 68
|
| |
|
|
| C 4179
|
| P. Marble
|
| Vol #:
|
| 68
|
| |
|
|
| C 4180
|
| K. Suomi
|
| Vol #:
|
| 68
|
|
| | | | | | | |
|
| |
|
| C 4181
|
| R. Miller
|
| Vol #:
|
| 68
|
| |
|
|
| C 4182
|
| R. Stinson
|
| Vol #:
|
| 68
|
| |
|
|
| C 4183
|
| S. Delaney
|
| Vol #:
|
| 68
|
| |
|
|
| C 4184
|
| D. Alber
|
| Vol #:
|
| 68
|
| |
|
|
| C 4185
|
| J. Kepka
|
| Vol #:
|
| 68
|
| |
|
|
| C 4186
|
| S. Kelso
|
| Vol #:
|
| 68
|
| |
|
|
| C 4187
|
| L. King
|
| Vol #:
|
| 68
|
| |
|
|
| C 4188
|
| D. Gillespie
|
| Vol #:
|
| 68
|
| |
|
|
| C 4189
|
| M. Troup
|
| Vol #:
|
| 68
|
| |
|
|
| C 4190
|
| B. Sparre
|
| Vol #:
|
| 68
|
| |
|
|
| C 4191
|
| F. Bianchi
|
| Vol #:
|
| 68
|
| |
|
|
| C 4192
|
| S. Frederick
|
| Vol #:
|
| 68
|
| |
|
|
| C 4193
|
| S. Wolford
|
| Vol #:
|
| 68
|
| |
|
|
| C 4194
|
| K. Hoggatt
|
| Vol #:
|
| 68
|
| |
|
|
| C 4195
|
| P. Taylor
|
| Vol #:
|
| 68
|
| |
|
|
| C 4196
|
| D. Lookman
|
| Vol #:
|
| 68
|
| |
|
|
| C 4197
|
| J. Klema, Jr.
|
| Vol #:
|
| 68
|
| |
|
|
| C 4198
|
| M. Demarco
|
| Vol #:
|
| 68
|
| |
|
|
| C 4199
|
| D. Hussey
|
| Vol #:
|
| 68
|
| |
|
|
| C 4200
|
| M. Farley
|
| Vol #:
|
| 68
|
| |
|
|
| C 4201
|
| M. Bell
|
| Vol #:
|
| 68
|
| |
|
|
| C 4202
|
| A. Shiveley
|
| Vol #:
|
| 68
|
| |
|
|
| C 4203
|
| Eligible
|
| Vol #:
|
| 68
|
| |
|
|
| C 4204
|
| S. Cooter
|
| Vol #:
|
| 68
|
| |
|
|
| C 4205
|
| R. Shore
|
| Vol #:
|
| 68
|
| |
|
|
| C 4206
|
| B. Teel
|
| Vol #:
|
| 68
|
| |
|
|
| C 4207
|
| C. Frazier
|
| Vol #:
|
| 68
|
| |
|
|
| C 4208
|
| S. Collins
|
| Vol #:
|
| 68
|
| |
|
|
| C 4209
|
| L. Breyer
|
| Vol #:
|
| 68
|
| |
|
|
| C 4210
|
| P. Bergstrand
|
| Vol #:
|
| 68
|
| |
|
|
| C 4211
|
| D. Strong
|
| Vol #:
|
| 68
|
| |
|
|
| C 4212
|
| N. Karstedt
|
| Vol #:
|
| 68
|
| |
|
|
| C 4213
|
| J. Russell
|
| Vol #:
|
| 68
|
| |
|
|
| C 4214
|
| I. Weiner
|
| Vol #:
|
| 68
|
| |
|
|
| C 4215
|
| V. Runyan
|
| Vol #:
|
| 68
|
| |
|
|
| C 4216
|
| C. Wayne
|
| Vol #:
|
| 68
|
| |
|
|
| C 4217
|
| J. Mullen
|
| Vol #:
|
| 68
|
|
| | | | | | | |
|
| |
|
| C 4218
|
| O. Morris, FNP
|
| Vol #:
|
| 68
|
| |
|
|
| C 4219
|
| F. Garner
|
| Vol #:
|
| 68
|
| |
|
|
| C 4220
|
| B. Thomson
|
| Vol #:
|
| 68
|
| |
|
|
| C 4221
|
| R. Burhenn
|
| Vol #:
|
| 68
|
| |
|
|
| C 4222
|
| K. Patla
|
| Vol #:
|
| 68
|
| |
|
|
| C 4223
|
| R. HArt
|
| Vol #:
|
| 68
|
| |
|
|
| C 4224
|
| P. Montero
|
| Vol #:
|
| 68
|
| |
|
|
| C 4225
|
| S. Hoover
|
| Vol #:
|
| 68
|
| |
|
|
| C 4226
|
| Y. Downs
|
| Vol #:
|
| 69
|
| |
|
|
| C 4227
|
| C. Sckenrode
|
| Vol #:
|
| 69
|
| |
|
|
| C 4228
|
| J. McKenzie
|
| Vol #:
|
| 69
|
| |
|
|
| C 4229
|
| S. Schultz
|
| Vol #:
|
| 69
|
| |
|
|
| C 4230
|
| S. Schultz
|
| Vol #:
|
| 69
|
| |
|
|
| C 4231
|
| S. Hardy
|
| Vol #:
|
| 69
|
| |
|
|
| C 4232
|
| V. Butters
|
| Vol #:
|
| 69
|
| |
|
|
| C 4233
|
| J. Alk
|
| Vol #:
|
| 69
|
| |
|
|
| C 4234
|
| C. Jones
|
| Vol #:
|
| 69
|
| |
|
|
| C 4235
|
| D. Altman
|
| Vol #:
|
| 69
|
| |
|
|
| C 4236
|
| D. Flack
|
| Vol #:
|
| 69
|
| |
|
|
| C 4237
|
| E. McIntosh
|
| Vol #:
|
| 69
|
| |
|
|
| C 4238
|
| B. Adams
|
| Vol #:
|
| 69
|
| |
|
|
| C 4239
|
| J. Elder
|
| Vol #:
|
| 69
|
| |
|
|
| C 4240
|
| C. Hughes
|
| Vol #:
|
| 69
|
| |
|
|
| C 4241
|
| A. Light
|
| Vol #:
|
| 69
|
| |
|
|
| C 4242
|
| E. Ham
|
| Vol #:
|
| 69
|
| |
|
|
| C 4243
|
| E. Ham
|
| Vol #:
|
| 69
|
| |
|
|
| C 4244
|
| L. BAker
|
| Vol #:
|
| 69
|
| |
|
|
| C 4245
|
| Eligible
|
| Vol #:
|
| 69
|
| |
|
|
| C 4246
|
| R. Bishop
|
| Vol #:
|
| 69
|
| |
|
|
| C 4247
|
| P. Roberts
|
| Vol #:
|
| 69
|
| |
|
|
| C 4248
|
| Eligible
|
| Vol #:
|
| 69
|
| |
|
|
| C 4249
|
| M. Wall
|
| Vol #:
|
| 69
|
| |
|
|
| C 4250
|
| E. Ledbetter
|
| Vol #:
|
| 69
|
| |
|
|
| C 4251
|
| C. Phillips
|
| Vol #:
|
| 69
|
| |
|
|
| C 4252
|
| S. Finney
|
| Vol #:
|
| 69
|
| |
|
|
| C 4253
|
| G. Bailey
|
| Vol #:
|
| 69
|
| |
|
|
| C 4254
|
| J. Walker
|
| Vol #:
|
| 69
|
|
| | | | | | | |
|
| |
|
| C 4255
|
| Eligible
|
| Vol #:
|
| 69
|
| |
|
|
| C 4256
|
| S. Brierley
|
| Vol #:
|
| 69
|
| |
|
|
| C 4257
|
| B. Garcia
|
| Vol #:
|
| 69
|
| |
|
|
| C 4258
|
| N. Meyer
|
| Vol #:
|
| 69
|
| |
|
|
| C 4259
|
| D. Treger
|
| Vol #:
|
| 69
|
| |
|
|
| C 4260
|
| C. Rubis
|
| Vol #:
|
| 69
|
| |
|
|
| C 4261
|
| L. Yucca
|
| Vol #:
|
| 69
|
| |
|
|
| C 4262
|
| J. Gondreaou
|
| Vol #:
|
| 69
|
| |
|
|
| EMC 397
|
| H. Spencer
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 398
|
| S. Singer
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 399
|
| M. Helin
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 400
|
| D. Abercrombie
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 401
|
| R. Shuman
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 402
|
| L. Jones
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 403
|
| M. McDonald
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 404
|
| G. Wilson
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 405
|
| D. Cross
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 406
|
| L. Baker
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 407
|
| M. Scharlack
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 408
|
| R. Fairchild
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 409
|
| M. Gross
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 410
|
| K. Schock
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 411
|
| K. Stratvert
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 412
|
| C. Weber
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 413
|
| D. Doheny
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 414
|
| M. West
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 415
|
| S. Minoli
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 416
|
| M. Swenson
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 417
|
| R. Walton
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 418
|
| S. MacQuarrie
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 419
|
| C. Besso
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 420
|
| O. Berntsen Jr.
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 421
|
| K. Lankford
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 422
|
| A. Castellano
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 423
|
| S. McKee
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 424
|
| M. Jordan
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 425
|
| D. Ritter
|
| Vol #:
|
| 39
|
|
| | | | | | | |
|
| |
|
| EMC 426
|
| E. McCool
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 427
|
| T. Carpenter
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 428
|
| J. Beutel
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 429
|
| K. Switzer
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 430
|
| V. Lawrence
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 431
|
| R. Rufe
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 432
|
| J. BenAmoz, R.Ph
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 433
|
| L. Becker
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 434
|
| D. Chamberlin
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 435
|
| E. Finders
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 436
|
| R. Twait
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 437
|
| R. Robertson
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 438
|
| J. Hutson
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 439
|
| J. Hutson
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 440
|
| K. Ivey
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 441
|
| V. Barre
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 442
|
| L. Benson
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 443
|
| D. Chen
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 444
|
| J. Black
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 445
|
| M. Townsend
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 446
|
| H. Simon
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 447
|
| K. Clark
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 448
|
| J. Helder
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 449
|
| F. Holzbach
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 450
|
| A. Pulley
|
| Vol #:
|
| 39
|
| |
|
|
| EMC 451
|
| J. Slatton
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 452
|
| K. Boozan
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 453
|
| A. Rosenberg
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 454
|
| B. Nasser
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 455
|
| B. Nadelman
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 456
|
| M. Deane
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 457
|
| R. Weir
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 458
|
| L. Tuttle
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 459
|
| K. Wolfe
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 460
|
| I. Papagno
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 461
|
| H. Mueller
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 462
|
| M. Edmondson
|
| Vol #:
|
| 76
|
|
| | | | | | | |
|
| |
|
| EMC 463
|
| P. Becker
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 464
|
| S. Reynolds
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 465
|
| M. Baker
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 466
|
| H. Tilgner
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 467
|
| E. MacInnis
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 468
|
| C. Oakleaf
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 469
|
| E. Page
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 470
|
| Y. Glendennin
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 471
|
| D. Saner
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 472
|
| S. Babiar
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 473
|
| J. Kenessey
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 474
|
| T. Hawkins
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 475
|
| J. Buckner
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 476
|
| J. Kenessey
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 477
|
| M. Giguere
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 478
|
| C. Bailey
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 479
|
| P. McPeak
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 480
|
| J. Stoner
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 481
|
| R. Sica, MD
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 482
|
| D. Stoner
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 483
|
| R. Dargan
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 484
|
| M. Bosna
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 485
|
| P. Battersby
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 486
|
| R. Conrad
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 487
|
| V. Master
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 488
|
| M. Frendel
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 489
|
| B. Minces
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 490
|
| C. Cassidy
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 491
|
| J. Hoagland
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 492
|
| D. Henry
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 493
|
| J. Bodfield
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 494
|
| M. Hatfield
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 495
|
| J. Sherwood
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 496
|
| D. Camilli
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 497
|
| C. Mills
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 498
|
| E. Karickhoff
|
| Vol #:
|
| 76
|
| |
|
|
| EMC 499
|
| R. Sheperd
|
| Vol #:
|
| 76
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| EMC 500
|
| K. Willis
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 501
|
| G. Glass
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 502
|
| A. Gardner
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 503
|
| J. Kelly
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 504
|
| S. Miller
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 505
|
| R. Walstra
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 506
|
| A. Wood
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 507
|
| S. Miller
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 508
|
| K. Stout
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 509
|
| G. Tilley
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 510
|
| S. Gates
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 511
|
| K. Hays
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 512
|
| C. Morris
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 513
|
| E. Skeen
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 514
|
| D. Fraley
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 515
|
| L. Jackson
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 516
|
| R. Malone
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 517
|
| L. Pines
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 518
|
| M. Hamilton
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 519
|
| M. Dib
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 520
|
| S. Rehorn
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 521
|
| B. Williamson
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 522
|
| R. Bush
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 523
|
| M. Cox
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 524
|
| J. Kolber
|
| Vol #:
|
| 76
|
|
|
|
|
| EMC 525
|
| E. Peterson
|
| Vol #:
|
| 76
|
|
|
|
|
| 2006P-0129
|
| to reclassify phenylpropanolamine(PPA)
wieght control drug product from category I to category II
|
|
|
|
|
| ACK 1
|
| number not used
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0131
|
| Make a determination
that Epirubicin Hydrochloride Injection, 2mg/ miin vialsizes of 10
mg/ 5 mi, 20 mg/ 10 mi and 200 mg/ 100 mi are suitable for submission
in an ANDA.
|
|
|
|
|
| ACK 1
|
| HFA-305 to AAC Consulting Group
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| AAC Consulting Group
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0135
|
| Issue Guidance
to Industry outlining procedures and standards for initiating an "expanded
access program" for unapproved drugs
|
|
|
|
|
| ACK 1
|
| HFA-305 to National Coalition
for Cancer Survivorship and American Society of Clinical Oncology
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| National Coalition for Cancer
Survivorship and American Society of Clinical Oncology
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006V-0134
|
| Laser Light Show
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ACK 1
|
| HFA-305 to Fun City LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR 1
|
| Fun City LLC
|
| Vol #:
|
| 1
|
|
|
