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| Dockets Management
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| Dockets Entered On
June 16, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 2000E-1252
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| Patent Extension Alamast #5,034,230
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| |
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| |
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| 2004E-0011
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| Patent Term Extention of U.S. patent No. 5,198,533 for Cetrotide (cetrorelix acetate)
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| 2004E-0314
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| Patent Extension for Spiriva HandiHaler (tiotropium bromide inhalation powder), U.S. Patent No. 5,610,163
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| 2004F-0546
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| FAP 2253) the safe use of polyurethane polymer coating in ruminant feed
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| 2005E-0245
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| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
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| 2005N-0016
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| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
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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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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| 2006E-0034
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| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
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| 2006E-0046
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| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
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| 2006E-0206
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| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
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| 2006E-0236
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| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
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| 2006E-0240
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| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
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| 2006E-0252
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| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
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| 2006M-0235
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| P050047 - Juvederm 24HV, Juvederm 30, and Juvederm 30HV Gel Implants
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| 2006N-0229
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| Carbinoxamine Products; Enforcement Action Dates
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| 2006P-0243
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| Qualified Health Claim: (QHC) : Corn oil and corn oil containing foods and heart disease
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| 2006P-0251
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| Label change or removal from the market of the psychotropic drug Depakote
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| 2006P-0253
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| ANDA Suitability for Loperamind Hydrochloride
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17878
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| Pure Pharmaceuticals, LLC
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| Vol #:
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| 165
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| LET 17879
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| Futurebiotics LLC
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| Vol #:
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| 165
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| LET 17880
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| Futurebiotics LLC
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| Vol #:
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| 165
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| LET 17881
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| Livengood -Lifestyles
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| Vol #:
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| 165
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| LET 17882
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| NOW Foods
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| Vol #:
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| 165
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| LET 17883
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| Econet, Inc., d.b.a. Oasis Lifesciences
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| Vol #:
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| 165
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| LET 17884
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| New Chapter, Inc.
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| Vol #:
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| 165
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| LET 17885
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| New Chapter, Inc.
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| Vol #:
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| 165
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| LET 17886
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| New Chapter, Inc.
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| Vol #:
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| 165
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| LET 17887
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| Body Rescue
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| Vol #:
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| 165
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| LET 17888
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| New Chapter, Inc.
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| Vol #:
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| 165
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| 2000E-1252
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| Patent Extension Alamast #5,034,230
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| LET 3
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| |
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| GDL 3
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| GUIDANCE
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| Vol #:
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| 5
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| NAD 3
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| FDA
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| Vol #:
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| 5
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| 2004E-0011
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| Patent Term Extention of U.S. patent No. 5,198,533 for Cetrotide (cetrorelix acetate)
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2004E-0314
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| Patent Extension for Spiriva HandiHaler (tiotropium bromide inhalation powder), U.S. Patent No. 5,610,163
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| LET 2
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| LET 3
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| LET 4
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| LET 5
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004F-0546
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| FAP 2253) the safe use of polyurethane polymer coating in ruminant feed
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 2005E-0245
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| Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
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| |
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| LET 2
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005N-0016
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| Agency Information Collection Activities; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
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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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| SS 1
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| Supporting Statement
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| Vol #:
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| 1
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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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| C 12907
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| R. Kohn
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| Vol #:
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| 154
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| C 12908
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| J. Huck
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| Vol #:
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| 154
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| C 12909
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| S. Snyder
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| Vol #:
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| 154
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| C 12910
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| K. Cansler
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| Vol #:
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| 154
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| C 12911
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| C. Foster
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| Vol #:
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| 154
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| C 12912
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| L. Ruskin
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| Vol #:
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| 154
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| C 12913
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| J. Owen
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| Vol #:
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| 154
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| C 12914
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| K. Koch
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| Vol #:
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| 154
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| C 12915
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| J. Adams
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| Vol #:
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| 154
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| C 12916
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| A. Alden
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| Vol #:
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| 154
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| C 12917
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| L. Dent
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| Vol #:
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| 154
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| C 12918
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| S. Chisin
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| Vol #:
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| 154
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| C 12919
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| L. Dent
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| Vol #:
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| 154
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| C 12920
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| M. Scott
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| Vol #:
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| 154
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| C 12921
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| L. Dent
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| Vol #:
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| 154
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| C 12922
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| V. Steinberg
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| Vol #:
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| 154
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| C 12923
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| E. Segmour
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| Vol #:
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| 154
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| C 12924
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| D. Bosio
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| Vol #:
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| 154
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| C 12925
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| P. Kotsch
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| Vol #:
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| 154
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| C 12926
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| J. Meckley
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| Vol #:
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| 154
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| C 12927
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| B. Hilts
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| Vol #:
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| 154
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| C 12928
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| J. Meckley
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| Vol #:
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| 154
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| C 12929
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| D. Hovey
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| Vol #:
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| 154
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| C 12930
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| E. Aronson
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| Vol #:
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| 154
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| C 12931
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| M. Michaell
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| Vol #:
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| 154
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| C 12932
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| D. Rubelmann
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| Vol #:
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| 154
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| C 12933
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| K. Johnson
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| Vol #:
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| 154
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| C 12934
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| L. Marks
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| Vol #:
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| 154
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| C 12935
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| J. Walton
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| Vol #:
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| 154
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| C 12936
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| M. Aquino
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| Vol #:
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| 154
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| |
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| C 12937
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| N. Call
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| Vol #:
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| 154
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| C 12938
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| D. Tinker
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| Vol #:
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| 154
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| C 12939
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| J. Erickson
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| Vol #:
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| 154
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| C 12940
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| L. Rulley
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| Vol #:
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| 154
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| C 12941
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| E. Peterson
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| Vol #:
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| 154
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| |
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| C 12942
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| M. Thompson
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| Vol #:
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| 154
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| |
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| C 12943
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| K. Cherovsky
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| Vol #:
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| 154
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| |
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| C 12944
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| K. Bittrick
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| Vol #:
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| 154
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| |
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| C 12945
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| E. Curtis
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| Vol #:
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| 154
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| |
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| C 12946
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| M. Mangan
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| Vol #:
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| 154
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| |
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| C 12947
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| E. Kunert
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| Vol #:
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| 154
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| |
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| C 12948
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| P. Slomsky
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| Vol #:
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| 154
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| |
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| C 12949
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| J. Bristow
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| Vol #:
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| 154
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| |
|
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| C 12950
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| E. Kickler
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| Vol #:
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| 154
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| |
|
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| C 12951
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| T. Fortner
|
| Vol #:
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| 154
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| |
|
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| C 12952
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| Eligible
|
| Vol #:
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| 154
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| |
|
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| C 12953
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| Eligible
|
| Vol #:
|
| 154
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| |
|
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| C 12954
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| D. Melton
|
| Vol #:
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| 154
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| |
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| C 12955
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| J. Cashman
|
| Vol #:
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| 154
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| |
|
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| C 12956
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| B. Kegel
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| Vol #:
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| 154
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| |
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| C 12957
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| M. McConchie
|
| Vol #:
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| 154
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|
| | | | | | | |
| |
|
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| C 12958
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| A. Kegel
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| Vol #:
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| 154
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| |
|
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| C 12959
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| L. Weidlein
|
| Vol #:
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| 154
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| |
|
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| C 12960
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| D. Miksta
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| Vol #:
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| 154
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| |
|
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| C 12961
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| D. Miksta
|
| Vol #:
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| 154
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| |
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| C 12962
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| C. Smith
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| Vol #:
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| 154
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| |
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| C 12963
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| C. DeFrancia
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| Vol #:
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| 154
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| |
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| C 12964
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| N. Aran
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| Vol #:
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| 154
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| |
|
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| C 12965
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| I. Johnson
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| Vol #:
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| 154
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| |
|
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| C 12966
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| D. Phelps
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| Vol #:
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| 154
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| |
|
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| C 12967
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| M. Phelps
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| Vol #:
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| 154
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| |
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| C 12968
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| Nebraska Pharmacists Association (NPA)
|
| Vol #:
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| 154
|
| |
|
|
| C 12969
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| T. Sawa
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| Vol #:
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| 154
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| |
|
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| C 12970
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| K. Klieman
|
| Vol #:
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| 154
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| |
|
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| C 12971
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| M. Teubner
|
| Vol #:
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| 154
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| |
|
|
| C 12972
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| L. Engle
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| Vol #:
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| 154
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| |
|
|
| C 12973
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| J. Miller
|
| Vol #:
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| 154
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| |
|
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| C 12974
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| G. Chivers
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| Vol #:
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| 154
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| |
|
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| C 12975
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| L. Kruggel
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| Vol #:
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| 154
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| |
|
|
| C 12976
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| M. Bolton
|
| Vol #:
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| 154
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| |
|
|
| C 12977
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| K. Hammond
|
| Vol #:
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| 154
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| |
|
|
| C 12978
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| C. Mathis
|
| Vol #:
|
| 154
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| |
|
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| C 12979
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| K. Edwards
|
| Vol #:
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| 154
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| |
|
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| C 12980
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| C. Beitz
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| Vol #:
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| 154
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| |
|
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| C 12981
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| S. Fowler
|
| Vol #:
|
| 154
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| |
|
|
| C 12982
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| L. Swanson
|
| Vol #:
|
| 154
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| |
|
|
| C 12983
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| E. Tirsley
|
| Vol #:
|
| 154
|
| |
|
|
| C 12984
|
| S. Tnsley
|
| Vol #:
|
| 154
|
| |
|
|
| C 12985
|
| J. Reischl
|
| Vol #:
|
| 154
|
| |
|
|
| C 12986
|
| M. Duncan
|
| Vol #:
|
| 154
|
| |
|
|
| C 12987
|
| B. Anderson
|
| Vol #:
|
| 154
|
| |
|
|
| C 12988
|
| L. DeNuccio
|
| Vol #:
|
| 154
|
| |
|
|
| C 12989
|
| W. Wood
|
| Vol #:
|
| 154
|
| |
|
|
| C 12990
|
| P. Jewett
|
| Vol #:
|
| 154
|
| |
|
|
| C 12991
|
| M. Campins
|
| Vol #:
|
| 154
|
| |
|
|
| C 12992
|
| E. Sluder
|
| Vol #:
|
| 154
|
| |
|
|
| C 12993
|
| S. Harper
|
| Vol #:
|
| 154
|
| |
|
|
| C 12994
|
| E. Waters
|
| Vol #:
|
| 154
|
|
| | | | | | | |
| |
|
|
| C 12995
|
| D. Miller
|
| Vol #:
|
| 154
|
| |
|
|
| C 12996
|
| D. Branch
|
| Vol #:
|
| 154
|
| |
|
|
| C 12997
|
| V. Stevens
|
| Vol #:
|
| 154
|
| |
|
|
| C 12998
|
| C. Brown
|
| Vol #:
|
| 154
|
| |
|
|
| C 12999
|
| D. Allen
|
| Vol #:
|
| 154
|
| |
|
|
| C 13000
|
| R. WIlliams
|
| Vol #:
|
| 154
|
| |
|
|
| C 13001
|
| J. Kamman
|
| Vol #:
|
| 154
|
| |
|
|
| C 13002
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13003
|
| B. Law
|
| Vol #:
|
| 154
|
| |
|
|
| C 13004
|
| M. Freel
|
| Vol #:
|
| 154
|
| |
|
|
| C 13005
|
| C. Farmer
|
| Vol #:
|
| 154
|
| |
|
|
| C 13006
|
| P. Whitehair
|
| Vol #:
|
| 154
|
| |
|
|
| C 13007
|
| R. Sorensen
|
| Vol #:
|
| 154
|
| |
|
|
| C 13008
|
| B. Stanley
|
| Vol #:
|
| 154
|
| |
|
|
| C 13009
|
| M. Look
|
| Vol #:
|
| 154
|
| |
|
|
| C 13010
|
| S. Houghton
|
| Vol #:
|
| 154
|
| |
|
|
| C 13011
|
| R. Thyret
|
| Vol #:
|
| 154
|
| |
|
|
| C 13012
|
| D. Hovey
|
| Vol #:
|
| 154
|
| |
|
|
| C 13013
|
| E. Aronson
|
| Vol #:
|
| 154
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| |
|
|
| C 13014
|
| M. Michaell
|
| Vol #:
|
| 154
|
| |
|
|
| C 13015
|
| D. Rubelmann
|
| Vol #:
|
| 154
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| |
|
|
| C 13016
|
| K. Johnson
|
| Vol #:
|
| 154
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| |
|
|
| C 13017
|
| L. Marks
|
| Vol #:
|
| 154
|
| |
|
|
| C 13018
|
| J. Walton
|
| Vol #:
|
| 154
|
| |
|
|
| C 13019
|
| M. Aquino
|
| Vol #:
|
| 154
|
| |
|
|
| C 13020
|
| S. Nichols
|
| Vol #:
|
| 154
|
| |
|
|
| C 13021
|
| R. Marceau
|
| Vol #:
|
| 154
|
| |
|
|
| C 13022
|
| C. Zarzycki
|
| Vol #:
|
| 154
|
| |
|
|
| C 13023
|
| P. Benston
|
| Vol #:
|
| 154
|
| |
|
|
| C 13024
|
| T. Paul
|
| Vol #:
|
| 154
|
| |
|
|
| C 13025
|
| T. Baldorado
|
| Vol #:
|
| 154
|
| |
|
|
| C 13026
|
| L. Kind
|
| Vol #:
|
| 154
|
| |
|
|
| C 13027
|
| T. Clark
|
| Vol #:
|
| 154
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| |
|
|
| C 13028
|
| D. Quine
|
| Vol #:
|
| 154
|
| |
|
|
| C 13029
|
| B. Skalka
|
| Vol #:
|
| 154
|
| |
|
|
| C 13030
|
| A. SMith
|
| Vol #:
|
| 154
|
| |
|
|
| C 13031
|
| P. Bierman
|
| Vol #:
|
| 154
|
|
| | | | | | | |
| |
|
|
| C 13032
|
| K. Nutt, R.N.
|
| Vol #:
|
| 154
|
| |
|
|
| C 13033
|
| T. Tinsley
|
| Vol #:
|
| 154
|
| |
|
|
| C 13034
|
| D. Sipp
|
| Vol #:
|
| 154
|
| |
|
|
| C 13035
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13036
|
| D. Susman
|
| Vol #:
|
| 154
|
| |
|
|
| C 13037
|
| K. Bond
|
| Vol #:
|
| 154
|
| |
|
|
| C 13038
|
| M. Campins
|
| Vol #:
|
| 154
|
| |
|
|
| C 13039
|
| H. Kokidko
|
| Vol #:
|
| 154
|
| |
|
|
| C 13040
|
| K. Wagner
|
| Vol #:
|
| 154
|
| |
|
|
| C 13041
|
| K. Terrebonne
|
| Vol #:
|
| 154
|
| |
|
|
| C 13042
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13043
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13044
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13045
|
| A. Edmiston
|
| Vol #:
|
| 154
|
| |
|
|
| C 13046
|
| K. Hartwell, Jr.
|
| Vol #:
|
| 154
|
| |
|
|
| C 13047
|
| B. Weintraub
|
| Vol #:
|
| 154
|
| |
|
|
| C 13048
|
| D. Kappenman
|
| Vol #:
|
| 154
|
| |
|
|
| C 13049
|
| B. Ruackenbush
|
| Vol #:
|
| 154
|
| |
|
|
| C 13050
|
| B. Beyter
|
| Vol #:
|
| 154
|
| |
|
|
| C 13051
|
| D. Solomon
|
| Vol #:
|
| 154
|
| |
|
|
| C 13052
|
| M. Thompson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13053
|
| S. McLean
|
| Vol #:
|
| 154
|
| |
|
|
| C 13054
|
| M. Robinson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13055
|
| C. Nichols
|
| Vol #:
|
| 154
|
| |
|
|
| C 13056
|
| P. Yolhein, MD
|
| Vol #:
|
| 154
|
| |
|
|
| C 13057
|
| T. Thompson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13058
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13059
|
| A. Coffin
|
| Vol #:
|
| 154
|
| |
|
|
| C 13060
|
| D. Fleming
|
| Vol #:
|
| 154
|
| |
|
|
| C 13061
|
| H. Johnson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13062
|
| K. Moore
|
| Vol #:
|
| 154
|
| |
|
|
| C 13063
|
| L. Cairns, MD
|
| Vol #:
|
| 154
|
| |
|
|
| C 13064
|
| S. Wilcox, CNM
|
| Vol #:
|
| 154
|
| |
|
|
| C 13065
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13066
|
| R. Cline
|
| Vol #:
|
| 154
|
| |
|
|
| C 13067
|
| S. Pritchard
|
| Vol #:
|
| 154
|
| |
|
|
| C 13068
|
| D. Parrish
|
| Vol #:
|
| 154
|
|
| | | | | | | |
| |
|
|
| C 13069
|
| Suzanne
|
| Vol #:
|
| 154
|
| |
|
|
| C 13070
|
| Pharmacists Society of the State of New York
|
| Vol #:
|
| 154
|
| |
|
|
| C 13071
|
| C. Haley
|
| Vol #:
|
| 154
|
| |
|
|
| C 13072
|
| B. Sommer
|
| Vol #:
|
| 154
|
| |
|
|
| C 13073
|
| R. Darner
|
| Vol #:
|
| 154
|
| |
|
|
| C 13074
|
| J. Burke
|
| Vol #:
|
| 154
|
| |
|
|
| C 13075
|
| S. Buttes
|
| Vol #:
|
| 154
|
| |
|
|
| C 13076
|
| L. Erickson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13077
|
| B. Robinson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13078
|
| C. Huffman
|
| Vol #:
|
| 154
|
| |
|
|
| C 13079
|
| C. Barber
|
| Vol #:
|
| 154
|
| |
|
|
| C 13080
|
| J. Meyer
|
| Vol #:
|
| 154
|
| |
|
|
| C 13081
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13082
|
| M. Manley
|
| Vol #:
|
| 154
|
| |
|
|
| C 13083
|
| J. Kauth
|
| Vol #:
|
| 154
|
| |
|
|
| C 13084
|
| M. Thomson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13085
|
| E. Kapehe
|
| Vol #:
|
| 154
|
| |
|
|
| C 13086
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13087
|
| J. Smith
|
| Vol #:
|
| 154
|
| |
|
|
| C 13088
|
| T. Iler
|
| Vol #:
|
| 154
|
| |
|
|
| C 13089
|
| J. Miller
|
| Vol #:
|
| 154
|
| |
|
|
| C 13090
|
| C. Brinkley
|
| Vol #:
|
| 154
|
| |
|
|
| C 13091
|
| C. Sanborn
|
| Vol #:
|
| 154
|
| |
|
|
| C 13092
|
| L. Williams
|
| Vol #:
|
| 154
|
| |
|
|
| C 13093
|
| B. Chat
|
| Vol #:
|
| 154
|
| |
|
|
| C 13094
|
| D. Wagner
|
| Vol #:
|
| 154
|
| |
|
|
| C 13095
|
| A. Feuerberg
|
| Vol #:
|
| 154
|
| |
|
|
| C 13096
|
| J. Bauer
|
| Vol #:
|
| 154
|
| |
|
|
| C 13097
|
| R> Stitt
|
| Vol #:
|
| 154
|
| |
|
|
| C 13098
|
| T. Pomerenke
|
| Vol #:
|
| 154
|
| |
|
|
| C 13099
|
| C. Sanborn
|
| Vol #:
|
| 154
|
| |
|
|
| C 13100
|
| L. Williams
|
| Vol #:
|
| 154
|
| |
|
|
| C 13101
|
| B. Chat
|
| Vol #:
|
| 154
|
| |
|
|
| C 13102
|
| D. Wagner
|
| Vol #:
|
| 154
|
| |
|
|
| C 13103
|
| A. Feuerberg
|
| Vol #:
|
| 154
|
| |
|
|
| C 13104
|
| J. Bauer
|
| Vol #:
|
| 154
|
| |
|
|
| C 13105
|
| T. Rogers
|
| Vol #:
|
| 154
|
|
| | | | | | | |
| |
|
|
| C 13106
|
| J. Smigel
|
| Vol #:
|
| 154
|
| |
|
|
| C 13107
|
| G. Dyer
|
| Vol #:
|
| 154
|
| |
|
|
| C 13108
|
| M. Allgood
|
| Vol #:
|
| 154
|
| |
|
|
| C 13109
|
| J. Bonney
|
| Vol #:
|
| 154
|
| |
|
|
| C 13110
|
| M. Lockhart
|
| Vol #:
|
| 154
|
| |
|
|
| C 13111
|
| C. Cunningham
|
| Vol #:
|
| 154
|
| |
|
|
| C 13112
|
| M. Reinhardt
|
| Vol #:
|
| 154
|
| |
|
|
| C 13113
|
| K. Clark
|
| Vol #:
|
| 154
|
| |
|
|
| C 13114
|
| J. Wynn
|
| Vol #:
|
| 154
|
| |
|
|
| C 13115
|
| B. MAddoux
|
| Vol #:
|
| 154
|
| |
|
|
| C 13116
|
| C. Kozyra
|
| Vol #:
|
| 154
|
| |
|
|
| C 13117
|
| K. Boss
|
| Vol #:
|
| 154
|
| |
|
|
| C 13118
|
| T. Pratt, M.D.
|
| Vol #:
|
| 154
|
| |
|
|
| C 13119
|
| S. Merians
|
| Vol #:
|
| 154
|
| |
|
|
| C 13120
|
| K. Severson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13121
|
| K. Freeman
|
| Vol #:
|
| 154
|
| |
|
|
| C 13122
|
| Dr. K. Maclsaac
|
| Vol #:
|
| 154
|
| |
|
|
| C 13123
|
| B. Downs
|
| Vol #:
|
| 154
|
| |
|
|
| C 13124
|
| B. Downs
|
| Vol #:
|
| 154
|
| |
|
|
| C 13125
|
| L. Reibling
|
| Vol #:
|
| 154
|
| |
|
|
| C 13126
|
| M. Schraer
|
| Vol #:
|
| 154
|
| |
|
|
| C 13127
|
| M. Fownes
|
| Vol #:
|
| 154
|
| |
|
|
| C 13128
|
| S. Bacon
|
| Vol #:
|
| 154
|
| |
|
|
| C 13129
|
| A. MArkopoulos
|
| Vol #:
|
| 154
|
| |
|
|
| C 13130
|
| R. Icenhour
|
| Vol #:
|
| 154
|
| |
|
|
| C 13131
|
| R. Icenhour
|
| Vol #:
|
| 154
|
| |
|
|
| C 13132
|
| B. Rahn
|
| Vol #:
|
| 154
|
| |
|
|
| C 13133
|
| M. Vannice
|
| Vol #:
|
| 154
|
| |
|
|
| C 13134
|
| A. Correale
|
| Vol #:
|
| 154
|
| |
|
|
| C 13135
|
| L. Kujala
|
| Vol #:
|
| 154
|
| |
|
|
| C 13136
|
| B. Skinner
|
| Vol #:
|
| 154
|
| |
|
|
| C 13137
|
| J. Morris
|
| Vol #:
|
| 154
|
| |
|
|
| C 13138
|
| B. Crawford
|
| Vol #:
|
| 154
|
| |
|
|
| C 13139
|
| T. Crawford
|
| Vol #:
|
| 154
|
| |
|
|
| C 13140
|
| C. Reece
|
| Vol #:
|
| 154
|
| |
|
|
| C 13141
|
| C. Mesenbrink
|
| Vol #:
|
| 154
|
| |
|
|
| C 13142
|
| Eligble
|
| Vol #:
|
| 154
|
|
| | | | | | | |
| |
|
|
| C 13143
|
| M. Lorensen
|
| Vol #:
|
| 154
|
| |
|
|
| C 13144
|
| C. Seltmann
|
| Vol #:
|
| 154
|
| |
|
|
| C 13145
|
| T. Frazier
|
| Vol #:
|
| 154
|
| |
|
|
| C 13146
|
| C. Helfers
|
| Vol #:
|
| 154
|
| |
|
|
| C 13147
|
| E. Karam
|
| Vol #:
|
| 154
|
| |
|
|
| C 13148
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13149
|
| K. Kunan
|
| Vol #:
|
| 154
|
| |
|
|
| C 13150
|
| E. MacDonald
|
| Vol #:
|
| 154
|
| |
|
|
| C 13151
|
| K. Kowalski
|
| Vol #:
|
| 154
|
| |
|
|
| C 13152
|
| T. Canta
|
| Vol #:
|
| 154
|
| |
|
|
| C 13153
|
| V. Phillips
|
| Vol #:
|
| 154
|
| |
|
|
| C 13154
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13155
|
| S. Fijlstra
|
| Vol #:
|
| 154
|
| |
|
|
| C 13156
|
| R. McConnell
|
| Vol #:
|
| 154
|
| |
|
|
| C 13157
|
| K. Henderson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13158
|
| D. Wyhe
|
| Vol #:
|
| 154
|
| |
|
|
| C 13159
|
| M. Johnson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13160
|
| S. Berglund
|
| Vol #:
|
| 154
|
| |
|
|
| C 13161
|
| C. Sein
|
| Vol #:
|
| 154
|
| |
|
|
| C 13162
|
| K. Stockton
|
| Vol #:
|
| 154
|
| |
|
|
| C 13163
|
| S. Jag
|
| Vol #:
|
| 154
|
| |
|
|
| C 13164
|
| R. Lehr
|
| Vol #:
|
| 154
|
| |
|
|
| C 13165
|
| J. Hoffman
|
| Vol #:
|
| 154
|
| |
|
|
| C 13166
|
| M. Johnson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13167
|
| L. Lebeau
|
| Vol #:
|
| 154
|
| |
|
|
| C 13168
|
| M. Wheeler
|
| Vol #:
|
| 154
|
| |
|
|
| C 13169
|
| C. Mathis
|
| Vol #:
|
| 154
|
| |
|
|
| C 13170
|
| M. Heverline
|
| Vol #:
|
| 154
|
| |
|
|
| C 13171
|
| S. Mircdema
|
| Vol #:
|
| 154
|
| |
|
|
| C 13172
|
| R. Motske, R.Ph.
|
| Vol #:
|
| 154
|
| |
|
|
| C 13173
|
| V. Lea
|
| Vol #:
|
| 154
|
| |
|
|
| C 13174
|
| M. Anderson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13175
|
| D. Anderson
|
| Vol #:
|
| 154
|
| |
|
|
| C 13176
|
| R. Bender
|
| Vol #:
|
| 154
|
| |
|
|
| C 13177
|
| J. Garland
|
| Vol #:
|
| 154
|
| |
|
|
| C 13178
|
| A. Cruz
|
| Vol #:
|
| 154
|
| |
|
|
| C 13179
|
| K. Livingston
|
| Vol #:
|
| 154
|
|
| | | | | | | |
| |
|
|
| C 13180
|
| R. Gauthier
|
| Vol #:
|
| 154
|
| |
|
|
| C 13181
|
| E. Gauthier
|
| Vol #:
|
| 154
|
| |
|
|
| C 13182
|
| G. Bass
|
| Vol #:
|
| 154
|
| |
|
|
| C 13183
|
| C. Holmes, D.O.
|
| Vol #:
|
| 154
|
| |
|
|
| C 13184
|
| P. Spanke
|
| Vol #:
|
| 154
|
| |
|
|
| C 13185
|
| D. Howell
|
| Vol #:
|
| 154
|
| |
|
|
| C 13186
|
| E. Thorns
|
| Vol #:
|
| 154
|
| |
|
|
| C 13187
|
| D. Woolsey
|
| Vol #:
|
| 154
|
| |
|
|
| C 13188
|
| M. Alva
|
| Vol #:
|
| 154
|
| |
|
|
| C 13189
|
| D. Bruins
|
| Vol #:
|
| 154
|
| |
|
|
| C 13190
|
| N. Braun
|
| Vol #:
|
| 154
|
| |
|
|
| C 13191
|
| A. Vernon
|
| Vol #:
|
| 154
|
| |
|
|
| C 13192
|
| P. Mentzer
|
| Vol #:
|
| 154
|
| |
|
|
| C 13193
|
| A. Miller
|
| Vol #:
|
| 154
|
| |
|
|
| C 13194
|
| Z. Bromley
|
| Vol #:
|
| 154
|
| |
|
|
| C 13195
|
| J. Brundage
|
| Vol #:
|
| 154
|
| |
|
|
| C 13196
|
| E. Thorns
|
| Vol #:
|
| 154
|
| |
|
|
| C 13197
|
| D. Sterling
|
| Vol #:
|
| 154
|
| |
|
|
| C 13198
|
| P. Marzano
|
| Vol #:
|
| 154
|
| |
|
|
| C 13199
|
| J. Jorden
|
| Vol #:
|
| 154
|
| |
|
|
| C 13200
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13201
|
| P. Stoltzfus
|
| Vol #:
|
| 154
|
| |
|
|
| C 13202
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13203
|
| P. Fineman
|
| Vol #:
|
| 154
|
| |
|
|
| C 13204
|
| J, Davis
|
| Vol #:
|
| 154
|
| |
|
|
| C 13205
|
| E. Hester
|
| Vol #:
|
| 154
|
| |
|
|
| C 13206
|
| S. Gentile
|
| Vol #:
|
| 154
|
| |
|
|
| C 13207
|
| J. Schmid
|
| Vol #:
|
| 154
|
| |
|
|
| C 13208
|
| A. Nadler
|
| Vol #:
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| 154
|
| |
|
|
| C 13209
|
| J. Helton
|
| Vol #:
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| 154
|
| |
|
|
| C 13210
|
| P. Goss
|
| Vol #:
|
| 154
|
| |
|
|
| C 13211
|
| L. Jeter
|
| Vol #:
|
| 154
|
| |
|
|
| C 13212
|
| D. Eyman
|
| Vol #:
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| 154
|
| |
|
|
| C 13213
|
| T. Gonyea
|
| Vol #:
|
| 154
|
| |
|
|
| C 13214
|
| S. Fox
|
| Vol #:
|
| 154
|
| |
|
|
| C 13215
|
| L. Steelsmith
|
| Vol #:
|
| 154
|
| |
|
|
| C 13216
|
| C> Toth
|
| Vol #:
|
| 154
|
|
| | | | | | | |
| |
|
|
| C 13217
|
| J. Nakagawa
|
| Vol #:
|
| 154
|
| |
|
|
| C 13218
|
| P. Hargett
|
| Vol #:
|
| 154
|
| |
|
|
| C 13219
|
| K. Nutt, RN
|
| Vol #:
|
| 154
|
| |
|
|
| C 13220
|
| M. Arnold
|
| Vol #:
|
| 154
|
| |
|
|
| C 13221
|
| I. Fox
|
| Vol #:
|
| 154
|
| |
|
|
| C 13222
|
| J. Burnett
|
| Vol #:
|
| 154
|
| |
|
|
| C 13223
|
| C. Cross
|
| Vol #:
|
| 154
|
| |
|
|
| C 13224
|
| L. Swift
|
| Vol #:
|
| 154
|
| |
|
|
| C 13225
|
| K. Doerge
|
| Vol #:
|
| 154
|
| |
|
|
| C 13226
|
| A. Taulton
|
| Vol #:
|
| 154
|
| |
|
|
| C 13227
|
| C. Mehlmann
|
| Vol #:
|
| 154
|
| |
|
|
| C 13228
|
| C. Vretta
|
| Vol #:
|
| 154
|
| |
|
|
| C 13229
|
| L. Martin
|
| Vol #:
|
| 154
|
| |
|
|
| C 13230
|
| P. Orr
|
| Vol #:
|
| 154
|
| |
|
|
| C 13231
|
| M. Hughbank
|
| Vol #:
|
| 154
|
| |
|
|
| C 13232
|
| C. Geist
|
| Vol #:
|
| 154
|
| |
|
|
| C 13233
|
| C. Peacock
|
| Vol #:
|
| 154
|
| |
|
|
| C 13234
|
| C. Fernigan
|
| Vol #:
|
| 154
|
| |
|
|
| C 13235
|
| M. Venable
|
| Vol #:
|
| 154
|
| |
|
|
| C 13236
|
| T. Meridith
|
| Vol #:
|
| 154
|
| |
|
|
| C 13237
|
| J. Lodge
|
| Vol #:
|
| 154
|
| |
|
|
| C 13238
|
| J. Coffey
|
| Vol #:
|
| 154
|
| |
|
|
| C 13239
|
| L. Johnston
|
| Vol #:
|
| 154
|
| |
|
|
| C 13240
|
| V. Trudez
|
| Vol #:
|
| 154
|
| |
|
|
| C 13241
|
| H. Whitney
|
| Vol #:
|
| 154
|
| |
|
|
| C 13242
|
| W. Devernney
|
| Vol #:
|
| 154
|
| |
|
|
| C 13243
|
| J. Dries
|
| Vol #:
|
| 154
|
| |
|
|
| C 13244
|
| N. Kaplan
|
| Vol #:
|
| 154
|
| |
|
|
| C 13245
|
| B. Kalmbach
|
| Vol #:
|
| 154
|
| |
|
|
| C 13246
|
| G. O'Hara
|
| Vol #:
|
| 154
|
| |
|
|
| C 13247
|
| G. O'Hara
|
| Vol #:
|
| 154
|
| |
|
|
| C 13248
|
| L. Fischer
|
| Vol #:
|
| 154
|
| |
|
|
| C 13249
|
| G. O'Hara
|
| Vol #:
|
| 154
|
| |
|
|
| C 13250
|
| G. O'Hara
|
| Vol #:
|
| 154
|
| |
|
|
| C 13251
|
| F. Disque
|
| Vol #:
|
| 154
|
| |
|
|
| C 13252
|
| J. Miller
|
| Vol #:
|
| 154
|
| |
|
|
| C 13253
|
| J. Herman
|
| Vol #:
|
| 154
|
|
| | | | | | | | |
| |
|
|
| C 13254
|
| Eligible
|
| Vol #:
|
| 154
|
| |
|
|
| C 13255
|
| C. Ashbacher
|
| Vol #:
|
| 154
|
| |
|
|
| C 13256
|
| L. Baldwin
|
| Vol #:
|
| 154
|
| |
|
|
| C 13257
|
| P. Harroun
|
| Vol #:
|
| 154
|
| |
|
|
| C 13258
|
| T. Streight
|
| Vol #:
|
| 154
|
| |
|
|
| C 13259
|
| D. Mark
|
| Vol #:
|
| 154
|
| |
|
|
| C 13260
|
| C. Strickman
|
| Vol #:
|
| 154
|
| |
|
|
| 2006D-0226
|
| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0034
|
| Patent Extension Application for PREVICOX (firocoxib), U. S. Patent No. 5,981,576
|
| |
|
|
| LET 2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0046
|
| Patent Extension Application for Onyx Liquid Embolic System (LES), U.S. Patent No. 5,667,767
|
| |
|
|
| LET 2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0206
|
| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
|
| |
|
|
| LET 3
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0236
|
| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
|
| |
|
|
| LET 2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0240
|
| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
|
| |
|
|
| LET 2
|
| HFD-005 to U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0252
|
| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
|
| |
|
|
| APP 1
|
| Novo Nordisk A/S
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006M-0235
|
| P050047 - Juvederm 24HV, Juvederm 30, and Juvederm 30HV Gel Implants
|
| |
|
|
| AAV 1
|
| Inamed Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0229
|
| Carbinoxamine Products; Enforcement Action Dates
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0243
|
| Qualified Health Claim: (QHC) : Corn oil and corn oil containing foods and heart disease
|
| |
|
|
| ACK 1
|
| FDA/CFSAN to ACH Food Companies, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| ACH Food Companies, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0251
|
| Label change or removal from the market of the psychotropic drug Depakote
|
|
| | | | | | | | |
| |
|
|
| ACK 1
|
| FDA-DDM to Maya F. Perrott
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Maya F. Perrott
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0253
|
| ANDA Suitability for Loperamind Hydrochloride
|
| |
|
|
| ACK 1
|
| FDA/ DDM to AAC Consulting Group
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| AAC Consulting Group
|
| Vol #:
|
| 1
|
|
|
