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| Dockets Entered
On September 8, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| |
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| |
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| |
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| |
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| 2001P-0549
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| Determination of Nitroglycerin Aerosol (sublingual)
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| |
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| |
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| 2004E-0019
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| Patent Extension, FUZEON (enfuvirtide), U.S. Patent No. 6,133,418
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| 2004E-0021
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| Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
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| 2004E-0040
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| Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
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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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| 2004E-0389
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| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
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| 2004E-0402
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| Patent Extension for AVASTIN (bevacizumab), U.S. Patent No. 6,054,297
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| 2004E-0445
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| Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
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| 2004V-0218
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| Laser Light Show
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| 2005E-0233
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| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
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| 2005E-0234
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| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
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| 2005E-0247
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| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
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| |
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| 2005E-0249
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| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
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| |
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| 2005E-0254
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| Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
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| 2005E-0258
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| Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
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| |
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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-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| |
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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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| |
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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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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| |
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006E-0033
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| Patent Extension Application for APTIVUS (tipranavir), U.S. Patent No. 5,852,195
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| |
|
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| 2006M-0367
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| P050023 - Tupos LV/ATx CRT-D, Kronos LV-T CRT-D, 505.U Programmer Software for the ICS 3000, A-K00.7.U Programmer Software for the EPR/TMS 1000PLUS and Corox OTW Steroid Lead
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| |
|
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| 2006N-0239
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
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| |
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| 2006N-0349
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| Risk Communication on Medical Devices: Sharing Perspectives
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| |
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006P-0102
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| Take appropriate remedial action relating to an apparent safety issue regarding Bellatal ER
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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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-0263
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| ANADA suitability for Neomycin
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| 2006P-0313
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| Removal of labeling for MediSense Precision Advanced Diabetes Management System
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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| 1978N-0065
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| Skin Bleaching Drug Products
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| C 25
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| J Robinson
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| Vol #:
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| 4
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| LET 17
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| FDA/Federal State Relations to Colleague
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| Vol #:
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| 4
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| |
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| C 138
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| STAT Pharmaceuticals
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| Vol #:
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| 6
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| |
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| C 139
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| American Veterinary Distributors Association AVDA
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| Vol #:
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| 6
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| C 131
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| STAT Pharmaceuticals
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| Vol #:
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| 10
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| C 132
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| American Veterinary Distributors Association AVDA
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| Vol #:
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| 10
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| |
|
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| C 7537
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| M Edwards
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| Vol #:
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| 339
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EC 3
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| Mr. Daniel Hoover
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| Vol #:
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| 3
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| 2001P-0549
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| Determination of Nitroglycerin Aerosol (sublingual)
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| WDL 1
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| Lachman Consultant Services Inc
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| Vol #:
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| 1
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 63
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| A Woolsey
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| Vol #:
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| 5
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| 2004E-0019
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| Patent Extension, FUZEON (enfuvirtide), U.S. Patent No. 6,133,418
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0021
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| Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0040
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| Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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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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| |
|
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0389
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| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
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| |
|
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0402
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| Patent Extension for AVASTIN (bevacizumab), U.S. Patent No. 6,054,297
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| |
|
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0445
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| Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
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| |
|
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004V-0218
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| Laser Light Show
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| |
|
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| VRA 2
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| FDA/CDRH to Dreamlight Laswer Productions
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| Vol #:
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| 1
|
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| 2005E-0233
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| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
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| |
|
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2005E-0234
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| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
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| |
|
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2005E-0247
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| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
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| |
|
|
| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2005E-0249
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| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
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| |
|
|
| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2005E-0254
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| Patent Extension Application for ERBITUX, U.S. Patent No. 6,217,866
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| |
|
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005E-0258
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| Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
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| |
|
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| LET 3
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| |
|
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| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
| |
|
|
| C 666
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| J Donnelly
|
| Vol #:
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| 23
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| |
|
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| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
|
|
|
|
| REF 1
Part 2
Part 3 |
| OMB Review
|
| Vol #:
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| 5
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18093
|
| N. Ballonoff
|
| Vol #:
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| 196
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| C 18094
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| K. Broughton
|
| Vol #:
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| 196
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| |
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| C 18095
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| M. Fritz
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| Vol #:
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| 196
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| |
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| C 18096
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| J. James
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| Vol #:
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| 196
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| C 18097
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| S. Aldrich
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| Vol #:
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| 196
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| C 18098
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| S. Thrower
|
| Vol #:
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| 196
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| |
|
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| C 18099
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| L. Traweek
|
| Vol #:
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| 196
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| |
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| C 18100
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| D. Green
|
| Vol #:
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| 196
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| |
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| C 18101
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| C. Mills
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| Vol #:
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| 196
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| |
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| C 18102
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| J. Brennick
|
| Vol #:
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| 196
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| |
|
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| C 18103
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| D. Fairbanks
|
| Vol #:
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| 196
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| |
|
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| C 18104
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| P. Elliott
|
| Vol #:
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| 196
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| |
|
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| C 18105
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| J. Caruso
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| Vol #:
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| 196
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| |
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| C 18106
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| N. Born
|
| Vol #:
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| 196
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| |
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| C 18107
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| V. Smith
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| Vol #:
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| 196
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| |
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| C 18108
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| M. Scarfone
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| Vol #:
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| 196
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| |
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| C 18109
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| R. Lee
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| Vol #:
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| 196
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| |
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| C 18110
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| M. Dudai
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| Vol #:
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| 196
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| C 18111
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| J. Dover
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| Vol #:
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| 196
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| |
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| C 18112
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| L. Childs
|
| Vol #:
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| 196
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| |
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| EC 33272
|
| Ms. Karin Minshull
|
| Vol #:
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| 197
|
| |
|
|
| 2006D-0226
|
| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
|
| |
|
|
| C 5
|
| STAT Pharmaceuticals
|
| Vol #:
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| 1
|
| |
|
|
| C 6
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| American Veterinary Distributors Association AVDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006D-0336
|
| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0033
|
| Patent Extension Application for APTIVUS (tipranavir), U.S. Patent No. 5,852,195
|
| |
|
|
| LET 4
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
|
| 2
|
| |
|
|
| 2006M-0367
|
| P050023 - Tupos LV/ATx CRT-D, Kronos LV-T CRT-D, 505.U Programmer Software for the ICS 3000, A-K00.7.U Programmer Software for the EPR/TMS 1000PLUS and Corox OTW Steroid Lead
|
|
|
|
|
|
|
|
|
| AAV 1
|
| Biotronik, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0067
|
| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
|
| |
|
|
| EC 1
|
| American Veterinary Medical Association
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EC 2
|
| National Aquaculture Association
|
| Vol #:
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| 1
|
| |
|
|
| 2006N-0239
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
|
| |
|
|
| NM 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2006N-0349
|
| Risk Communication on Medical Devices: Sharing Perspectives
|
| |
|
|
| NM 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
| |
|
|
| C 1
|
| B Martini
|
| Vol #:
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| 1
|
| |
|
|
| EC 61
|
| Life Sciences Research Office
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 96
|
| L. Houle
|
| Vol #:
|
| 2
|
| |
|
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| EMC 97
|
| D. Cook
|
| Vol #:
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| 2
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| |
|
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| EMC 98
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| J. Gleiter
|
| Vol #:
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| 2
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| |
|
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| EMC 99
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| A. Chang
|
| Vol #:
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| 2
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| |
|
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| EMC 100
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| T. Gastaldo
|
| Vol #:
|
| 2
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| |
|
|
| EMC 101
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| A. Welber
|
| Vol #:
|
| 2
|
| |
|
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| EMC 102
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| A. Welber
|
| Vol #:
|
| 2
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| |
|
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| EMC 103
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| M. Elloian
|
| Vol #:
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| 2
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| |
|
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| EMC 104
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| C. Vincent
|
| Vol #:
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| 2
|
| |
|
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| EMC 105
|
| Arizona State University-School of Materials
|
| Vol #:
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| 2
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| |
|
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| EMC 106
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| C. Gochenour
|
| Vol #:
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| 2
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| |
|
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| EMC 107
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| S. Richardson
|
| Vol #:
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| 2
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| |
|
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| EMC 108
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| K. Smith
|
| Vol #:
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| 2
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| |
|
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| EMC 109
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| B. Bills
|
| Vol #:
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| 2
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| |
|
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| EMC 110
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| B. Yeary
|
| Vol #:
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| 2
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| |
|
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| EMC 111
|
| S. Richardson
|
| Vol #:
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| 2
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| |
|
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| EMC 112
|
| I. Lawrence
|
| Vol #:
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| 2
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| |
|
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| EMC 113
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| M. Vanwyhe
|
| Vol #:
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| 2
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| |
|
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| EMC 114
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| M. Skeels
|
| Vol #:
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| 2
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| |
|
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| EMC 115
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| D. Barbier
|
| Vol #:
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| 2
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| |
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| EMC 116
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| S. Carol
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| Vol #:
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| 2
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| |
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| EMC 117
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| J. Lewis
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| Vol #:
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| 2
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| |
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| EMC 118
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| M. Block
|
| Vol #:
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| 2
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| |
|
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| EMC 119
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| Pure Water Committee of Western Maryland, Inc.
|
| Vol #:
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| 2
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| |
|
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| EMC 120
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| M. Brake
|
| Vol #:
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| 2
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| |
|
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| EMC 121
|
| University of Georgia-Department of Microbiology
|
| Vol #:
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| 2
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| |
|
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| EMC 122
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| V. Brandt
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| Vol #:
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| 2
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|
| | | | | | | |
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| |
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| EMC 123
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| S. Taylor
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| Vol #:
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| 2
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| |
|
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| EMC 124
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| A. Gruber
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| Vol #:
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| 2
|
| |
|
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| EMC 125
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| R. Foreman
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| Vol #:
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| 2
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| |
|
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| EMC 126
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| K. Buck
|
| Vol #:
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| 2
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| |
|
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| EMC 127
|
| S. Michetti
|
| Vol #:
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| 2
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| |
|
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| EMC 128
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| R. Petro
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| Vol #:
|
| 2
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| |
|
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| EMC 129
|
| R. Foreman
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| Vol #:
|
| 2
|
| |
|
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| EMC 130
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| R. Fischer
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| Vol #:
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| 2
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| |
|
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| EMC 131
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| L. Shein
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| Vol #:
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| 2
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| |
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| EMC 132
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| R. Foreman
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| Vol #:
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| 2
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| EMC 133
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| R. Harrison
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| Vol #:
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| 2
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| |
|
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| EMC 134
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| C. Darling
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| Vol #:
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| 2
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| EMC 135
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| C. Peeples
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| Vol #:
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| 2
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| |
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| EMC 136
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| D. Veilleux
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| Vol #:
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| 2
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| |
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| EMC 137
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| C. Oss
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| Vol #:
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| 2
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| |
|
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| EMC 138
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| R. Burrows
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| Vol #:
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| 2
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| |
|
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| EMC 139
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| D. Watkins
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| Vol #:
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| 2
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| |
|
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| EMC 140
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| H. Garlinger
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| Vol #:
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| 2
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| |
|
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| EMC 141
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| J. Zwaal
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| Vol #:
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| 5
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| |
|
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| EMC 142
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| L. Deutsch
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| Vol #:
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| 5
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| |
|
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| EMC 143
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| J. Wasko
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| Vol #:
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| 5
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| |
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|
| EMC 144
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| T. Ormanski
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| Vol #:
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| 5
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| |
|
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| EMC 145
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| R. Montoya
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| Vol #:
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| 5
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| |
|
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| EMC 146
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| T. Moore
|
| Vol #:
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| 5
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| |
|
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| EMC 147
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| C. Rees
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| Vol #:
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| 5
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| |
|
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| EMC 148
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| L. Griffin
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| Vol #:
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| 5
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| |
|
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| EMC 149
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| K. Rose
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| Vol #:
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| 5
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| |
|
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| EMC 150
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| G. Bedding
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| Vol #:
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| 5
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| |
|
|
| EMC 151
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| R. Gunnigle
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| Vol #:
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| 5
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| |
|
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| EMC 152
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| J. Canady
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| Vol #:
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| 5
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| |
|
|
| EMC 153
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| J. Canady
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| Vol #:
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| 5
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| |
|
|
| EMC 154
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| C. Brown
|
| Vol #:
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| 5
|
| |
|
|
| EMC 155
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| S. Stefanec
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| Vol #:
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| 5
|
| |
|
|
| EMC 156
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| Y. Gulezian
|
| Vol #:
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| 5
|
| |
|
|
| EMC 157
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| T. Paolucci'
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| Vol #:
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| 5
|
| |
|
|
| EMC 158
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| J. Brown
|
| Vol #:
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| 5
|
| |
|
|
| EMC 159
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| J. Brown
|
| Vol #:
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| 5
|
|
| | | | | | | |
|
| |
|
| EMC 160
|
| Santa Monicans for Safe Drinking Water Coalition
|
| Vol #:
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| 5
|
| |
|
|
| EMC 161
|
| F. Hohn
|
| Vol #:
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| 5
|
| |
|
|
| EMC 162
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| V. Cain
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| Vol #:
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| 5
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| |
|
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| EMC 163
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| O'Connor Health Center
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| Vol #:
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| 5
|
| |
|
|
| EMC 164
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| Protect All Children's Environment
|
| Vol #:
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| 5
|
| |
|
|
| EMC 165
|
| M. Jones
|
| Vol #:
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| 5
|
| |
|
|
| EMC 166
|
| R. Fecteau
|
| Vol #:
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| 5
|
| |
|
|
| EMC 167
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| B. Dziuban
|
| Vol #:
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| 5
|
| |
|
|
| EMC 168
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| R. Schmidt
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| Vol #:
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| 5
|
| |
|
|
| EMC 169
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| J. Grapek
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| Vol #:
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| 5
|
| |
|
|
| EMC 170
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| H. Spagna
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| Vol #:
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| 5
|
| |
|
|
| EMC 171
|
| M. Brandt
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| Vol #:
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| 5
|
| |
|
|
| EMC 172
|
| S. Bucha
|
| Vol #:
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| 5
|
| |
|
|
| EMC 173
|
| D. Rhoades
|
| Vol #:
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| 5
|
| |
|
|
| EMC 174
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| V. Nolan
|
| Vol #:
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| 5
|
| |
|
|
| EMC 175
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| K. Calabrese
|
| Vol #:
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| 5
|
| |
|
|
| EMC 176
|
| M. Schultz-Holcomb
|
| Vol #:
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| 5
|
| |
|
|
| EMC 177
|
| R. McFerran
|
| Vol #:
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| 5
|
| |
|
|
| EMC 178
|
| S. Simmons
|
| Vol #:
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| 5
|
| |
|
|
| EMC 179
|
| B. Wilkie
|
| Vol #:
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| 5
|
| |
|
|
| EMC 180
|
| P. Gilbert
|
| Vol #:
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| 5
|
| |
|
|
| EMC 181
|
| V. Barber
|
| Vol #:
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| 5
|
| |
|
|
| EMC 182
|
| T. Patton
|
| Vol #:
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| 5
|
| |
|
|
| EMC 183
|
| E. Williams
|
| Vol #:
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| 5
|
| |
|
|
| EMC 184
|
| S. Jones
|
| Vol #:
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| 5
|
| |
|
|
| EMC 185
|
| L. Foster
|
| Vol #:
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| 5
|
| |
|
|
| EMC 186
|
| P. Wheeldon
|
| Vol #:
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| 5
|
| |
|
|
| EMC 187
|
| L. Mowbray
|
| Vol #:
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| 5
|
| |
|
|
| EMC 188
|
| K. Dudek
|
| Vol #:
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| 5
|
| |
|
|
| EMC 189
|
| E. Bubar
|
| Vol #:
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| 5
|
| |
|
|
| EMC 190
|
| B. Osmunson
|
| Vol #:
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| 5
|
| |
|
|
| EMC 191
|
| C. Arroyo-Otero
|
| Vol #:
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| 5
|
| |
|
|
| EMC 192
|
| M. Woo
|
| Vol #:
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| 5
|
| |
|
|
| EMC 193
|
| L. Adams
|
| Vol #:
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| 5
|
| |
|
|
| EMC 194
|
| T. Bolen
|
| Vol #:
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| 5
|
| |
|
|
| EMC 195
|
| T. Bolen
|
| Vol #:
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| 5
|
| |
|
|
| EMC 196
|
| L. Adams
|
| Vol #:
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| 5
|
|
| | | | | | | |
|
|
|
| EMC 197
|
| W. Snodgrass
|
| Vol #:
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| 5
|
| |
|
|
| EMC 198
|
| I. Lawrence
|
| Vol #:
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| 5
|
| |
|
|
| EMC 199
|
| P. Wheeldon
|
| Vol #:
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| 5
|
| |
|
|
| EMC 200
|
| A. Kilmartin
|
| Vol #:
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| 5
|
| |
|
|
| EMC 201
|
| R. Waltman
|
| Vol #:
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| 5
|
| |
|
|
| EMC 202
|
| C. Spencer
|
| Vol #:
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| 5
|
| |
|
|
| EMC 203
|
| C. Ward
|
| Vol #:
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| 5
|
| |
|
|
| EMC 204
|
| G. Marshall
|
| Vol #:
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| 5
|
| |
|
|
| EMC 205
|
| D. Schmidt
|
| Vol #:
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| 5
|
| |
|
|
| EMC 206
|
| E. McDonagh
|
| Vol #:
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| 5
|
| |
|
|
| EMC 207
|
| F. Pane
|
| Vol #:
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| 5
|
| |
|
|
| EMC 208
|
| R. Montoya
|
| Vol #:
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| 5
|
| |
|
|
| EMC 209
|
| J. Megalo
|
| Vol #:
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| 5
|
| |
|
|
| EMC 210
|
| T. Plumb
|
| Vol #:
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| 5
|
| |
|
|
| EMC 211
|
| R. Olson
|
| Vol #:
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| 5
|
| |
|
|
| EMC 212
|
| R. Olson
|
| Vol #:
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| 5
|
| |
|
|
| EMC 213
|
| M. Haines
|
| Vol #:
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| 5
|
| |
|
|
| EMC 214
|
| P. Owen
|
| Vol #:
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| 5
|
| |
|
|
| EMC 215
|
| Uppsala Universitet-Department of Earth Sciences, Air & Water Science
|
| Vol #:
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| 5
|
| |
|
|
| EMC 216
|
| S. Rossi
|
| Vol #:
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| 5
|
| |
|
|
| EMC 217
|
| K. Nelson
|
| Vol #:
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| 5
|
| |
|
|
| EMC 218
|
| S. Rossi
|
| Vol #:
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| 5
|
| |
|
|
| EMC 219
|
| J. Riggs
|
| Vol #:
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| 5
|
| |
|
|
| EMC 220
|
| P. Lalk
|
| Vol #:
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| 5
|
| |
|
|
| EMC 221
|
| J. Tarling
|
| Vol #:
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| 5
|
| |
|
|
| EMC 222
|
| E. Gioumousis
|
| Vol #:
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| 5
|
| |
|
|
| EMC 223
|
| L. Cifelli
|
| Vol #:
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| 5
|
| |
|
|
| EMC 224
|
| L. Cifelli
|
| Vol #:
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| 5
|
| |
|
|
| EMC 225
|
| J. Gianoli
|
| Vol #:
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| 5
|
| |
|
|
| EMC 226
|
| J. Trustone
|
| Vol #:
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| 5
|
| |
|
|
| EMC 227
|
| Australian Fluoridation Information Network
|
| Vol #:
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| 5
|
| |
|
|
| EMC 228
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 229
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 230
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 231
|
| P. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 232
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 233
|
| B. Windham
|
| Vol #:
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| 5
|
|
| | | | | | | |
|
| |
|
| EMC 234
|
| P. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 235
|
| P. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 236
|
| P. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 237
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 238
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 239
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 240
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 241
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 242
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 243
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 244
|
| B. Windham
|
| Vol #:
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| 5
|
| |
|
|
| EMC 245
|
| D. Dondot
|
| Vol #:
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| 5
|
| |
|
|
| EMC 246
|
| K. Fontaine
|
| Vol #:
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| 5
|
| |
|
|
| EMC 247
|
| K. Martin
|
| Vol #:
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| 5
|
| |
|
|
| EMC 248
|
| S. Murray
|
| Vol #:
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| 5
|
| |
|
|
| EMC 249
|
| C. Hallet
|
| Vol #:
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| 5
|
| |
|
|
| EMC 250
|
| M. McIlwain
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 251
|
| S. Moore-Hines
|
| Vol #:
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| 5
|
| |
|
|
| EMC 252
|
| B. Osmunson
|
| Vol #:
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| 5
|
| |
|
|
| EMC 253
|
| S. M.
|
| Vol #:
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| 5
|
| |
|
|
| EMC 254
|
| S. O'Neail
|
| Vol #:
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| 5
|
| |
|
|
| EMC 255
|
| Number Not Used
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 256
|
| P. Anderson
|
| Vol #:
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| 5
|
| |
|
|
| EMC 257
|
| M. Hauck
|
| Vol #:
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| 5
|
| |
|
|
| EMC 258
|
| D. Frigo
|
| Vol #:
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| 5
|
| |
|
|
| EMC 259
|
| C. Neurath
|
| Vol #:
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| 5
|
| |
|
|
| EMC 260
|
| C. Tomashofski
|
| Vol #:
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| 5
|
| |
|
|
| EMC 261
|
| L. Thomas
|
| Vol #:
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| 5
|
| |
|
|
| EMC 262
|
| R. Talmadge
|
| Vol #:
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| 5
|
| |
|
|
| EMC 263
|
| K. Moore
|
| Vol #:
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| 5
|
| |
|
|
| EMC 264
|
| J. Abdu
|
| Vol #:
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| 5
|
| |
|
|
| EMC 265
|
| T. Johnson
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 266
|
| Delta Dental Plans Association
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 267
|
| D. LaBrie
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 268
|
| J. Wehrie
|
| Vol #:
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| 5
|
| |
|
|
| EMC 269
|
| A. Siess
|
| Vol #:
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| 5
|
| |
|
|
| EMC 270
|
| L. Cone
|
| Vol #:
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| 5
|
|
| | | | | | | |
|
| |
|
| EMC 271
|
| T. McIlvaine
|
| Vol #:
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| 5
|
| |
|
|
| EMC 272
|
| J. M.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 273
|
| A. Matthei
|
| Vol #:
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| 5
|
| |
|
|
| EMC 274
|
| B. Zander
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 275
|
| M. & J. Impellizzeri
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 276
|
| C.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 277
|
| S. Farrell
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 278
|
| C. Impellizzeri
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 279
|
| C. Leavitt
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 280
|
| M. Koerner
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 281
|
| M. Koerner
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 282
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 283
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 284
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 285
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 286
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 287
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 288
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 289
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 290
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 291
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 292
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 293
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 294
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 295
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 296
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 297
|
| B. Windham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 298
|
| P. Windham
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 299
|
| P. Windham
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 300
|
| B. Windham
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 301
|
| B. Windham
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 302
|
| R. Dudley
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 303
|
| K. Williams
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 304
|
| V. High
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 305
|
| J. Hausmann
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 306
|
| J. Dunn
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 307
|
| J. Dunn
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
| |
|
| EMC 308
|
| W. Whitworth
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 309
|
| V. High
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 310
|
| J. Duncan
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 311
|
| E. Birlem
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 312
|
| National Association of Dental Plans
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 313
|
| National Health Freedom Action
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 314
|
| L. Ramos
|
| Vol #:
|
| 6
|
| |
|
|
| 2006P-0102
|
| Take appropriate remedial action relating to an apparent safety issue regarding Bellatal ER
|
| |
|
|
| LET 1
|
| FDA/CDER to Lord, bissell & Brook LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
|
|
|
|
|
|
|
|
|
| EC 587
|
| Mrs. Brad Tate
|
| Vol #:
|
| 5
|
| |
|
|
| EC 588
|
| Mr. Daniel Hoover
|
| Vol #:
|
| 5
|
| |
|
|
| EC 589
|
| Mr. Eric Wold
|
| Vol #:
|
| 5
|
| |
|
|
| EC 590
|
| Mr. Jeremy Baker
|
| Vol #:
|
| 5
|
| |
|
|
| 2006P-0251
|
| Label change or removal from the market of the psychotropic drug Depakote
|
| |
|
|
| EC 4
|
| Mr. Daniel Hoover
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0263
|
| ANADA suitability for Neomycin
|
| |
|
|
| WDL 1
|
| FDA/CVM to Sparhawk Laboratories, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0299
|
| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
|
| |
|
|
| C 2
|
| D Love
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0313
|
| Removal of labeling for MediSense Precision Advanced Diabetes Management System
|
| |
|
|
| WDL 1
|
| Bayer HealthCare LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0371
|
| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
|
|
|
|
|
|
|
|
|
| ACK 1
|
| FDA/DDM to Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
|
|
