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| Dockets Entered
On October 23, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 2000E-1252
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| Patent Extension Alamast #5,034,230
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| 2003E-0418
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| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
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| 2004E-0308
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| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
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| 2006E-0022
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| Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
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| 2006E-0025
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| Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
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| 2006E-0042
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| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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| 2007D-0201
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| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
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| 2007D-0290
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| Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
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| 2007N-0182
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
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| 2007N-0186
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| Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
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| 2007N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension
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| 2007N-0321
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0382
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| Ramipril Capsules and 180-day generic drug exclusivity
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| 2007P-0074
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| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
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| 2007P-0079
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| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
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| 2007P-0235
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| Change the labeling requirements for eggs sold in the United States
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| 2007P-0400
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| Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
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| 2007P-0407
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| To permit the filling of a Abbreiated new drug application (ANDA) for Abacavir Sulfate Tablets 60 mg
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 2463
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| Mrs. Jane Whitten
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| Vol #:
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| 162
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| EXT 13
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| L'OREAL
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| Vol #:
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| 162
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| 2000E-1252
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| Patent Extension Alamast #5,034,230
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| CEP 1
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| U.S. Patent and Trademark Office to Perkins Cole LLP
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| Vol #:
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| 1
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| 2003E-0418
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| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
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| LET 6
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| U.S. Patent and Trademark Office to Merck & Co., Inc.
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| Vol #:
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| 1
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| 2004E-0308
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| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
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| CEP 1
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| U.S. Patent and Trademark Office to Burns, Doane, Swecker & Mathis, LLP
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| Vol #:
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| 1
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| 2006E-0022
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| Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
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| CEP 1
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| U.S. Patent and Trademark Office to Amylin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2006E-0025
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| Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
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| CEP 1
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| U.S. Patent and Trademark Office to Heller Ehrmann, LLP
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| Vol #:
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| 1
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| 2006E-0042
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| Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
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| CEP 1
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| U.S. Patent and Trademark Office to Cubist Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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| CEP 1
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| U.S. Patent and Trademark Office to Foley & Lardner
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| Vol #:
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| 1
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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| LET 6
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| U.S. Patent and Trademark Office to Novartis
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| Vol #:
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| 1
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| 2007D-0201
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| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
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| C 4
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| American Academy of Orthopadic Surgeons (AAOS)
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| Vol #:
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| 1
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| 2007D-0290
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| Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
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| EC 3
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| Biosafe
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| Vol #:
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| 1
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| EC 4
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| On behalf of device company to remain anonymous
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| 1
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| EC 5
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| American Society for Apheresis
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| Vol #:
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| 1
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| 2007N-0182
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
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| EC 1
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| Mr. W. H. Boyd
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| Vol #:
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| 1
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| 2007N-0186
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| Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
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| C 2
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| Bergstrom Nutrition
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| Vol #:
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| 1
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| EREG 2
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| T. DuBose
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| Vol #:
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| 1
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| 2007N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension
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| EC 1
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| Boehringer Ingelheim Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2007N-0321
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct
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| C 2
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| Pfizer
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| Vol #:
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| 1
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| C 3
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| Sanofi Aventis
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| Vol #:
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| 1
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| C 4
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| Wyeth
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| Vol #:
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| 1
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| EC 23
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| Pfizer, Inc.
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| Vol #:
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| 1
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| EC 24
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| AstraZeneca LP
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| Vol #:
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| 1
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| EC 25
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| Eli Lilly and Company
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| Vol #:
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| 1
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| EC 26
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| Families USA
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| Vol #:
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| 1
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| EC 27
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| Kaiser Permanente Center for Health Research
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| Vol #:
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| 1
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| EC 28
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| Pharmaceutical Research and Manufacturers of Ameri
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| Vol #:
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| 1
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| EC 29
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| Davidson & Company
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| Vol #:
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| 1
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| 2007N-0356
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| Behind The Counter
Availability of Certain Drugs; Public Meeting
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| EAPE 162
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| Elge, Inc.
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| Vol #:
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| 1
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| EAPE 163
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| National Community Pharmacists Association
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| Vol #:
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| 1
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| EAPE 164
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| FDA/CDER
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| Vol #:
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| 1
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| EAPE 165
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| FDA/CDER/DDI
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| Vol #:
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| 1
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| EAPE 166
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| PEGUS Research
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| Vol #:
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| 1
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| EAPE 167
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| National Community Pharmacists Association
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| Vol #:
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| 1
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| EAPE 168
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| National Women's Law Center
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| Vol #:
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| 1
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| EAPE 169
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| Society for Women's Health Research
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| Vol #:
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| 1
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| EAPE 170
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| Pinney Associates
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| Vol #:
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| 1
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| EAPE 171
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| sanofi-aventis
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| Vol #:
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| 1
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| EAPE 172
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| 3D Communications
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| Vol #:
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| 1
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| EAPE 173
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| Bayer HealthCare
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| Vol #:
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| 1
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| EAPE 174
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| Healthcare Distribution Management Association
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| Vol #:
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| 1
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| EAPE 175
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| Drug Benefit Trends
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| Vol #:
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| 1
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| EAPE 176
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| Leesburg Pharmacy
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| Vol #:
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| 1
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| EAPE 177
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| Covington & Burling LLP
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| Vol #:
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| 1
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| EAPE 178
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| FDA
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| Vol #:
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| 1
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| EAPE 179
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| Planned Parenthood Health Systems, Inc.
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| Vol #:
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| 1
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| EAPE 180
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| Planned Parenthood Health Systems, Inc.
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| Vol #:
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| 1
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| EAPE 181
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| CVS Caremark
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| Vol #:
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| 1
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| EAPE 182
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| Harbor-UCLA Medical Center
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| Vol #:
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| 1
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| EAPE 183
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| PCMA
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| Vol #:
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| 1
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| EC 19
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| Dr. Michele Kaufman
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| Vol #:
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| 1
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| EC 20
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| Ms. Katelyn Nicolosi
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| Vol #:
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| 1
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| EC 21
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| Dr. Charles Bonanno
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| Vol #:
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| 1
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| EC 22
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| Dr. APRIL SMITH
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| Vol #:
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| 1
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| EC 23
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| Mrs. Sue Walter
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| Vol #:
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| 1
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| EC 24
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| Ms. Monique Baran
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| Vol #:
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| 1
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| 2007N-0382
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| Ramipril Capsules and 180-day generic drug exclusivity
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| C 1
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| Arent Fox
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| Vol #:
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| 1
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| C 2
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| Ranbaxy, Inc.
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| Vol #:
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| 1
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| C 3
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| FOLEY & LARDNER LLP
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| Vol #:
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| 1
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| EC 1
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| Express Scripts, Inc.
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| Vol #:
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| 1
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| EC 2
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| Apotex
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| Vol #:
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| 1
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| EC 3
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| Pharmaceutical Care Management Association
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| Vol #:
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| 1
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| 2007P-0074
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| Over-the-Counter (OTC) Cough and Cold Drug Products for Children Under 6 Years of Age
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| EC 17
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| Ms. Kathleen Corcoran
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| Vol #:
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| 1
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| 2007P-0079
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| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
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| SUP 2
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| D. Richardson
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| Vol #:
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| 1
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| 2007P-0235
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| Change the labeling requirements for eggs sold in the United States
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| C 199
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| C. Graeff
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| Vol #:
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| 2
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| C 200
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| A. Robb
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| Vol #:
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| 2
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| C 201
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| M. Neese
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| Vol #:
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| 2
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| C 202
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| J. Mantooth
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| Vol #:
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| 2
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| C 203
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| L. Wapner
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| Vol #:
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| 2
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| C 204
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| Unknown
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| Vol #:
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| 2
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| C 205
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| M. Kagy
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| Vol #:
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| 2
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| C 206
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| B. Burns
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| Vol #:
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| 2
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| C 207
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| W. Wilson
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| Vol #:
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| 2
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| C 208
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| E. Schaefer
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| Vol #:
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| 2
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| 2007P-0400
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| Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
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| EC 1
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| Ms. Dorothy Davis
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| Vol #:
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| 1
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| 2007P-0407
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| To permit the filling of a Abbreiated new drug application (ANDA) for Abacavir Sulfate Tablets 60 mg
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| ACK 1
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| FDA/ DDM/ to Matrix Laboratories, Inc.
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| Vol #:
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| 1
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| CP 1
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| Matrix Laboratories, Inc.
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| Vol #:
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| 1
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