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| Dockets Entered
On April 10, 2007
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| Docket #
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| Title
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| 1993P-0049
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| Propranolol effervescent tablets 20mg, 60mg, 80mg, & 90mg
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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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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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| 2007E-0138
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| Patent Extension Application for ArteFill, U.S. Patent No. 5,344,452
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| 2007E-0139
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| Patent Extension Application for Vectibix (panitumumab), U.S. Patent No. 6,235,883
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007P-0110
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| To enforce pediatric exclusivity rights for amlodipine
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| 2007P-0111
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| Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity
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| 2007P-0116
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| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
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| 2007P-0140
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| Stay final approval and/or effective date of final approval of any 0.4. mg Norethindrone and 35 microgram Ethinyl Estradiol oral chewable tablet product ANDAs unless there is pharmaceutical e
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| ACK 5
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| FDA/DDM to Century Pharmaceuticals, Inc
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| Vol #:
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| 13
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| CP 5
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| Century Pharmaceuticals, Inc. (CPI)
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| Vol #:
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| 13
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| 1993P-0049
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| Propranolol effervescent tablets 20mg, 60mg, 80mg, & 90mg
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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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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 19870
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| Bodyhealth.com Corporation
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| Vol #:
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| 175
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| LET 19871
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| Source Naturals
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| Vol #:
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| 175
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| LET 19872
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| Solstice Medicine Company
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| Vol #:
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| 175
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| LET 19873
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| Solstice Medicine Company
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| Vol #:
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| 175
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| LET 19874
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| Planetary Herbals
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| Vol #:
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| 175
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| LET 19875
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| Iovate Health Sciences U.S.A. Inc.
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| Vol #:
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| 175
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| LET 19876
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| Iovate Health Sciences U.S.A. Inc.
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| Vol #:
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| 175
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| LET 19877
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| Bodyhealth.com Corporation
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| Vol #:
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| 175
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| LET 19878
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| Iovate Health Sciences U.S.A. Inc.
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| Vol #:
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| 175
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| LET 19879
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| ITV Marketing Group, Inc. d/b/a/ ITV Ventures
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| Vol #:
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| 175
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| LET 19880
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19881
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| NBTY Inc.
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| Vol #:
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| 175
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| LET 19882
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| Source Naturals
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| Vol #:
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| 175
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| LET 19883
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| Source Naturals
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| Vol #:
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| 175
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| LET 19884
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19885
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19886
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19887
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19888
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19889
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19890
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19891
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19892
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19893
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19894
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19895
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19896
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19897
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19898
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19899
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19900
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19901
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19902
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19903
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19904
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 175
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| LET 19905
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| Indiana Botanic Gardens, Inc.
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| Vol #:
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| 175
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| LET 19906
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| Indiana Botanic Gardens, Inc.
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| Vol #:
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| 175
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| LET 19907
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| Indiana Botanic Gardens, Inc.
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| Vol #:
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| 175
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| LET 19908
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| Indiana Botanic Gardens, Inc.
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| Vol #:
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| 175
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| LET 19909
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| Indiana Botanic Gardens, Inc.
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| Vol #:
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| 175
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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|
| | | | | | | | |
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| EMC 794
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| Calorie Control Council
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| Vol #:
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| 10
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| EMC 795
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| Mission Possible International
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| Vol #:
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| 10
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| |
|
|
| NFR 2
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| FDA
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| Vol #:
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| 1
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| |
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| EMC 179
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| Y. Hansen
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| Vol #:
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| 5
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| EMC 180
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| D. Eisemann
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| Vol #:
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| 5
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| EMC 181
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| J. Dahill
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| Vol #:
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| 5
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| EMC 182
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| T. Smith
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| Vol #:
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| 5
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| EMC 183
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| E. MacInnis
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| Vol #:
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| 5
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| EMC 184
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| P. Grames
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| Vol #:
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| 5
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| EMC 185
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| The Annie Appleseed Project
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| Vol #:
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| 5
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| EMC 186
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| R. Newman
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| Vol #:
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| 5
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| EMC 187
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| S. Smith
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| Vol #:
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| 5
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| EMC 188
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| B. MacLauchlin
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| Vol #:
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| 5
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| EMC 189
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| J. Sexton
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| Vol #:
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| 5
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| EMC 190
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| M. Sanders
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| Vol #:
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| 5
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| EMC 191
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| D. Tsakiridis
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| Vol #:
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| 5
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| EMC 192
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| S. Stone
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| Vol #:
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| 5
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| EMC 193
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| S. Prazenka
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| Vol #:
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| 5
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| EMC 194
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| P. Bullock
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| Vol #:
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| 5
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| EMC 195
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| C. Shetterly
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| Vol #:
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| 5
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| EMC 196
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| M. McGrath
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| Vol #:
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| 5
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| EMC 197
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| M. & D. Lanciano
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| Vol #:
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| 5
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| EMC 198
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| J. Muldoon
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| Vol #:
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| 5
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| EMC 199
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| J. Rebara
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| Vol #:
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| 5
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| EMC 200
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| K. Stoner
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| Vol #:
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| 5
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| EMC 201
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| B. Jennings
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| Vol #:
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| 5
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| EMC 202
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| S. Guy
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| Vol #:
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| 5
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| EMC 203
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| P. Conroy
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| Vol #:
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| 5
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| EMC 204
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| L. Yarrow
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| Vol #:
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| 5
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| EMC 205
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| S. Waks
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| Vol #:
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| 5
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| |
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| EMC 206
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| R. Bjorklund
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| Vol #:
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| 5
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| |
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| EMC 207
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| K. Mclean
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| Vol #:
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| 5
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| |
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| EMC 208
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| R. Pessin
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| Vol #:
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| 5
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| EMC 209
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| D. Lisk
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| Vol #:
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| 5
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| EMC 210
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| L. Coviello
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| Vol #:
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| 5
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| |
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| EMC 211
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| S. Marriott
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| Vol #:
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| 5
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| |
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| EMC 212
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| G. Coffey
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| Vol #:
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| 5
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| |
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| EMC 213
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| C. Winberg
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| Vol #:
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| 5
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| EMC 214
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| L. Augustine
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| Vol #:
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| 5
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| EMC 215
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| J. Blair
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| Vol #:
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| 5
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| EMC 216
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| E. Wolter
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| Vol #:
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| 5
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| EMC 217
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| M. Barnes
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| Vol #:
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| 5
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| |
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| EMC 218
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| M. Hamilton
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| Vol #:
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| 5
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| EMC 219
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| B. Maclauchlin
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| Vol #:
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| 5
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| EMC 220
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| P. Holladay
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| Vol #:
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| 5
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| |
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| EMC 221
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| J. Kitchen
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| Vol #:
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| 5
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| EMC 222
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| K. Hunter
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| Vol #:
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| 5
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| |
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| EMC 223
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| J. Larsen
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| Vol #:
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| 5
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| |
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| EMC 224
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| D. Mullan
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| Vol #:
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| 5
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| |
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| EMC 225
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| J. Mahar
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| Vol #:
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| 5
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| EMC 226
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| R. Carricaburu
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| Vol #:
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| 5
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| |
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| EMC 227
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| S. Dunbar
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| Vol #:
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| 5
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| EMC 228
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| J. Gerstley
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| Vol #:
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| 5
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| EMC 229
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| M. Kruczek
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| Vol #:
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| 5
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| |
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| EMC 230
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| J. Kosovich
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| Vol #:
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| 5
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| EMC 231
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| L. Stubbs
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| Vol #:
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| 5
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| EMC 232
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| L. Smith
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| Vol #:
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| 5
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| |
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| EMC 233
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| M. Lanciano
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| Vol #:
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| 5
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| |
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| EMC 234
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| H. Goulding
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| Vol #:
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| 5
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| |
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| EMC 235
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| L. Kalvin
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| Vol #:
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| 5
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| |
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| EMC 236
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| W. Ballentine
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| Vol #:
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| 5
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| |
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| EMC 237
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| V. Wood
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| Vol #:
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| 5
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| |
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| EMC 238
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| G. Eldridge
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| Vol #:
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| 5
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| |
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| EMC 239
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| P. Zarchin
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| Vol #:
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| 5
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| |
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| EMC 240
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| R. Elbert
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| Vol #:
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| 5
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| |
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| EMC 241
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| T. Ahring
|
| Vol #:
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| 5
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| |
|
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| EMC 242
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| M. Malmgren
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| Vol #:
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| 5
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| |
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| EMC 243
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| J. Hurd
|
| Vol #:
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| 5
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| |
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| EMC 244
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| K. Krivit
|
| Vol #:
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| 5
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| |
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| EMC 245
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| M. Freeman
|
| Vol #:
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| 5
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|
| | | | | | | | |
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| |
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| EMC 246
|
| Lois Freeman
|
| Vol #:
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| 5
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| |
|
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| EMC 247
|
| M. Niedenfuer
|
| Vol #:
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| 5
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| |
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| EMC 248
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| L. Salter
|
| Vol #:
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| 5
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| |
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| EMC 249
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| L. Ploskey
|
| Vol #:
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| 5
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| |
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| EMC 250
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| D. Davis
|
| Vol #:
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| 5
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| |
|
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| EMC 251
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| M. Wolfe
|
| Vol #:
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| 5
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| |
|
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| EMC 252
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| L. Livarchuk
|
| Vol #:
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| 5
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| |
|
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| EMC 253
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| K. Meyer
|
| Vol #:
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| 5
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| |
|
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| EMC 254
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| J. Bullock
|
| Vol #:
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| 5
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| |
|
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| EMC 255
|
| K. Friese
|
| Vol #:
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| 5
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| |
|
|
| EMC 256
|
| M. Benetua
|
| Vol #:
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| 5
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| |
|
|
| EMC 257
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| F. Margalit
|
| Vol #:
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| 5
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| |
|
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| EMC 258
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| J. Schultz
|
| Vol #:
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| 5
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| |
|
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| EMC 259
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| M. Saiz
|
| Vol #:
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| 5
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| |
|
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| EMC 260
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| D. Zaldua-Hilkene
|
| Vol #:
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| 5
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| |
|
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| EMC 261
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| J. Dion
|
| Vol #:
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| 5
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| |
|
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| EMC 262
|
| G. Burke
|
| Vol #:
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| 5
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| |
|
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| EMC 263
|
| M. Richardson
|
| Vol #:
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| 5
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| |
|
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| EMC 264
|
| K. Mathis
|
| Vol #:
|
| 5
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| |
|
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| EMC 265
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| T. Ashley
|
| Vol #:
|
| 5
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| |
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| EMC 266
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| S. Walsh
|
| Vol #:
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| 5
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| |
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| EMC 267
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| C. Bishop
|
| Vol #:
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| 5
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| |
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| EMC 268
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| J. Palmer
|
| Vol #:
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| 5
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| |
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| EMC 269
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| L. Duffy
|
| Vol #:
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| 5
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| |
|
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| EMC 270
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| R. Donnelly
|
| Vol #:
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| 5
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| |
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| EMC 271
|
| T. McDonnell
|
| Vol #:
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| 5
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| |
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| EMC 272
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| C. Launay
|
| Vol #:
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| 5
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| |
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| EMC 273
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| E. Alberts
|
| Vol #:
|
| 5
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| |
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| EMC 274
|
| L. Anderson
|
| Vol #:
|
| 5
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| |
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| EMC 275
|
| M. Kaehn
|
| Vol #:
|
| 5
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| |
|
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| EMC 276
|
| S. Ullstrup
|
| Vol #:
|
| 5
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| |
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| EMC 277
|
| J. Stein
|
| Vol #:
|
| 5
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| |
|
|
| EMC 278
|
| D. Shields
|
| Vol #:
|
| 5
|
| |
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing, and Handling of Food
|
| |
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| EC 1
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| Mrs. Colleen Hodakowski
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| Vol #:
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| 6
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| |
|
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| EC 2
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| Mr. Daryl Daughters
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| Vol #:
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| 6
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| | | | | | | |
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| |
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| EC 3
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| Mr. Gary Willms
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| Vol #:
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| 6
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| |
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| EC 4
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| Mr. William Colburn
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| Vol #:
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| 6
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| |
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| EC 5
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| Mr. William Cross
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| Vol #:
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| 6
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| |
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| EC 6
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| Mrs. Linda Hughley
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| Vol #:
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| 6
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| |
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| EC 7
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| Mr. Elias Mallar
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| Vol #:
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| 6
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| |
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| EC 8
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| Mr. Larry Scofield
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| Vol #:
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| 6
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| |
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| EC 9
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| Ms. Elizabeth Payne
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| Vol #:
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| 6
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| |
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| EC 10
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| Mrs. Diana Sekhon
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| Vol #:
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| 6
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| |
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| EC 11
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| Mr. Jeff Omiecinski
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| Vol #:
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| 6
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| |
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| EC 12
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| Alpha Awareness Centre
|
| Vol #:
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| 6
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| |
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| EC 13
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| Mr. Eric Paquin
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| Vol #:
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| 6
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| |
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| EC 14
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| Mr. Daniel Malooly
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| Vol #:
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| 6
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| |
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| EC 15
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| Mr. Adam Robertson
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| Vol #:
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| 6
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| |
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| EC 16
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| Mrs. Katherine Zerby
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| Vol #:
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| 6
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| |
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| EC 17
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| Ms. Claudia Gutierrez
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| Vol #:
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| 6
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| |
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| EC 18
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| Dr. jenay katkowsky
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| Vol #:
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| 6
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| |
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| EC 19
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| Ms. Zsuzsanna Molnar
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| Vol #:
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| 6
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| |
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| EC 20
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| Mr. Wayne Lill Jr
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| Vol #:
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| 6
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| |
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| EC 21
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| ICERS
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| Vol #:
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| 6
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| |
|
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| EC 22
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| Mr. Brock Parker
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| Vol #:
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| 6
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| |
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| EC 23
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| Ms. Nancy Williams
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| Vol #:
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| 6
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| |
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| EC 24
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| Mrs. DIANA TAPELT
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| Vol #:
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| 6
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| |
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| EC 25
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| Mr. Lee McCard
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| Vol #:
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| 6
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| |
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| EC 26
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| Mr. Joseph Liberatore
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| Vol #:
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| 6
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| |
|
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| EC 27
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| Mr. Daryl Moore
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| Vol #:
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| 6
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| |
|
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| EC 28
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| Ms. KATHLEEN ROSO
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| Vol #:
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| 6
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| |
|
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| EC 29
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| Mr. Joe Harrington
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| Vol #:
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| 6
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| |
|
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| EC 30
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| Mr. Robert Walker
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| Vol #:
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| 6
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| |
|
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| EC 31
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| Mr. richard othuse
|
| Vol #:
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| 6
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| |
|
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| EC 32
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| Mrs. Kimberly Toole
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| Vol #:
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| 6
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| |
|
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| EC 33
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| Ms. Brenda Robertson
|
| Vol #:
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| 6
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| |
|
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| EC 34
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| Ms. k. Corum
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| Vol #:
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| 6
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| |
|
|
| EC 35
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| Mr. Joseph Skurla
|
| Vol #:
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| 6
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| |
|
|
| EC 36
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| Mr. Frank Crawford
|
| Vol #:
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| 6
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| |
|
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| EC 37
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| Mr. Vernon Davis
|
| Vol #:
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| 6
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| |
|
|
| EC 38
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| Mr. Chris Altimari
|
| Vol #:
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| 6
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| |
|
|
| EC 39
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| Mr. Stephen Swain
|
| Vol #:
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| 6
|
|
| | | | | | | |
|
| |
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| EC 40
|
| Mrs. Aubrey Hess
|
| Vol #:
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| 6
|
| |
|
|
| EC 41
|
| Mrs. Rosina Giles
|
| Vol #:
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| 6
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| |
|
|
| EC 42
|
| Mr. Roger Kondrad
|
| Vol #:
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| 6
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| |
|
|
| EC 43
|
| Mrs. susan price
|
| Vol #:
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| 6
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| |
|
|
| EC 44
|
| Ms. judy gehring
|
| Vol #:
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| 6
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| |
|
|
| EMC 7
|
| J. Levinson
|
| Vol #:
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| 5
|
| |
|
|
| EMC 8
|
| M. Marsh
|
| Vol #:
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| 5
|
| |
|
|
| EREG 3
|
| S. Wolf
|
| Vol #:
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| 4
|
| |
|
|
| EREG 4
|
| L. Riley
|
| Vol #:
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| 4
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| |
|
|
| EREG 5
|
| R. Riches
|
| Vol #:
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| 4
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| |
|
|
| EREG 6
|
| L. Norlander
|
| Vol #:
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| 4
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| |
|
|
| EREG 7
|
| E. Carnesi
|
| Vol #:
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| 4
|
| |
|
|
| EREG 8
|
| Food For Life Co-op
|
| Vol #:
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| 4
|
| |
|
|
| EREG 9
|
| Blue Heron Organics & Natural Products
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 10
|
| D. Chase
|
| Vol #:
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| 4
|
| |
|
|
| EREG 11
|
| L. Olsen
|
| Vol #:
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| 4
|
| |
|
|
| EREG 12
|
| G. Kennedy
|
| Vol #:
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| 4
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| |
|
|
| EREG 13
|
| Hygeia
|
| Vol #:
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| 4
|
| |
|
|
| EREG 14
|
| R. Burt
|
| Vol #:
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| 4
|
| |
|
|
| EREG 15
|
| A. Honda
|
| Vol #:
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| 4
|
| |
|
|
| EREG 16
|
| J. Bradley
|
| Vol #:
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| 4
|
| |
|
|
| EREG 17
|
| B. Jacques
|
| Vol #:
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| 4
|
| |
|
|
| EREG 18
|
| No Submitter
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 19
|
| A. Duke
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 20
|
| T. Sochowicz
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 21
|
| J. Thompson
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 22
|
| Discovery Foods Buying Club
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 23
|
| A. Korotki
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 24
|
| E. Fernandez
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 25
|
| E. Wadds
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 26
|
| K. Ranney
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 27
|
| G. Hart
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 28
|
| J. Woodman
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 29
|
| D. Simon-Baker
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 30
|
| J. Paige
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 31
|
| J. Wight
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 32
|
| R. Carey
|
| Vol #:
|
| 4
|
|
| | | | | | | |
|
| |
|
| EREG 33
|
| D. Hall
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 34
|
| C. Smith
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 35
|
| E. Skekinah
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 36
|
| Organic Consumers
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 37
|
| L. Borst
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 38
|
| M. King
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 39
|
| J. Cosman
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 40
|
| S. Novell
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 41
|
| J. Novell
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 42
|
| M. Laplume
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 43
|
| A. & M.
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 44
|
| www.luxefaire.com
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 45
|
| J. & J. Freeman
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 46
|
| R. Rohn
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 47
|
| S. Jones
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 48
|
| L. Osmar
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 49
|
| T. Teague
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 50
|
| J. Cannone
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 51
|
| B. Winkelman
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 52
|
| F. C. I.
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 53
|
| D. Hunt
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 54
|
| No Submitter
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 55
|
| B. Bingham
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 56
|
| Children's Medical Group, P. C.
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 57
|
| Naclo Health Products
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 58
|
| M. Deago
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 59
|
| H. Steele
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 60
|
| E. Landies
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 61
|
| E. Charpenter
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 62
|
| K. Rapsher
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 63
|
| C. Tayler-Houle
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 64
|
| S. Samnick
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 65
|
| A. Carlsson
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 66
|
| T. Hahn
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 67
|
| Brandeis University
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 68
|
| R. Fiddler
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 69
|
| K. Garcia
|
| Vol #:
|
| 4
|
|
| | | | | | | |
|
| |
|
| EREG 70
|
| E. Pope
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 71
|
| Author
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 72
|
| G. Clark
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 73
|
| J. O'Neill
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 74
|
| L. Schlegel
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 75
|
| M. Welke
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 76
|
| R. Cossutta
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 77
|
| University of Montana
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 78
|
| W. Belknap
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 79
|
| Concerned Citizens About Our Welfare
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 80
|
| D. & C. Dierkes
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 81
|
| Illinois State University
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 82
|
| University of California at Davis
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 83
|
| St. Xavier University
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 84
|
| Q. Miralia
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 85
|
| R. Bye
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 86
|
| N. Jardim
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 87
|
| Union of Concerned Scientists
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 88
|
| S. Shouse
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 89
|
| M. Eager
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 90
|
| M. Moore
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 91
|
| J. Parker
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 92
|
| Union of Concerned Scientisis
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 93
|
| A. Guskin
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 94
|
| C. Hsiao
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 95
|
| M. Wagner
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 96
|
| Oasis Montana, Inc.
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 97
|
| J. Robinson
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 98
|
| C. Andelin
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 99
|
| S. Hill
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 100
|
| Seattle Tilth
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 101
|
| J. Schwartzentruber
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 102
|
| D. Erway
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 103
|
| K. Clemmons
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 104
|
| G. Dickel
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 105
|
| N. Moll
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 106
|
| UpFront Organization Development Consulting
|
| Vol #:
|
| 4
|
|
| | | | | | | |
|
| |
|
| EREG 107
|
| Union of Concerned Scientisis
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 108
|
| N. Stack
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 109
|
| Group Health
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 110
|
| H. Ledet
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 111
|
| C. Olsen
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 112
|
| E. Dowdy
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 113
|
| B. Waldman
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 114
|
| J. Skaggs
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 115
|
| R. Berlant
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 116
|
| K. Heikkila
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 117
|
| P. Cass
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 118
|
| C. Anderson
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 119
|
| Union of Concerned Scientisis
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 120
|
| Polarity Center of Salem
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 121
|
| B. Arden
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 122
|
| H. Fuchs
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 123
|
| L. Webb
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 124
|
| American Citizen
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 125
|
| Spindletree, LLC
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 126
|
| D. Narveson
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 127
|
| L. Albee
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 128
|
| W. Ebersberger
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 129
|
| K. Murphy
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 130
|
| D. Romesburg
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 131
|
| E. Stabiner
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 132
|
| S. Small
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 133
|
| S. Franks
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 134
|
| V. Downs
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 135
|
| J. Gomolka
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 136
|
| E. Dymkowski
|
| Vol #:
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| 4
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| |
|
|
| EREG 137
|
| P. Sheridan
|
| Vol #:
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| 4
|
| |
|
|
| EREG 138
|
| B. Jackson
|
| Vol #:
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| 4
|
| |
|
|
| EREG 139
|
| C. Palmer
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 140
|
| University of Florida
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 141
|
| A. Goodner
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 142
|
| W. Lee
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 143
|
| J. Mota
|
| Vol #:
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| 4
|
|
| | | | | | | | |
|
| |
|
| EREG 144
|
| J. Drabek
|
| Vol #:
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| 4
|
| |
|
|
| EREG 145
|
| R. Pelizzari
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 146
|
| Caltech
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 147
|
| D. Artley
|
| Vol #:
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| 4
|
| |
|
|
| EREG 148
|
| W. Coulter
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 149
|
| A. Milliman
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 150
|
| Actor's Equity Association
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 151
|
| Union of Concerned Scientisis
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 152
|
| T. Hansard
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 153
|
| Union of Concerned Scientists
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 154
|
| T. Sargent
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 155
|
| M. Whittle
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 156
|
| Union of Concerned Scientists
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 157
|
| Margqueete Organic Food Cooperative
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 158
|
| E. Zerin
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 159
|
| R. Mathsen
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 160
|
| U. N. H.
|
| Vol #:
|
| 4
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| EC 1887
|
| Mrs. Janet Stoeckel
|
| Vol #:
|
| 31
|
|
| |
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18291
|
| Valley Apothecary
|
| Vol #:
|
| 198
|
| |
|
|
| C 18292
|
| B. Davidson
|
| Vol #:
|
| 198
|
| |
|
|
| C 18293
|
| J. Klemme
|
| Vol #:
|
| 198
|
| |
|
|
| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
| |
|
|
| EMC 10
|
| M. Abruzese
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 11
|
| D. Walko
|
| Vol #:
|
| 7
|
| |
|
|
| 2006D-0480
|
| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
|
| |
|
|
| EMC 1
|
| L. Drey-Nightingale
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| C 79
|
| M. Edwards
|
| Vol #:
|
| 7
|
| |
|
|
| C 80
|
| Animal Welfare Institute
|
| Vol #:
|
| 7
|
| |
|
|
| 2007D-0101
|
| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
|
|
|
|
|
|
|
|
| | | | | | | | |
|
| |
|
| C 1
|
| National Organization for Rare Disorders, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0117
|
| Guidance for Industry on Orally Disintegrating Tablets
|
| |
|
|
| EMC 1
|
| S. P. I. Pharma
|
| Vol #:
|
| 1
|
|
| |
|
| 2007E-0138
|
| Patent Extension Application for ArteFill, U.S. Patent No. 5,344,452
|
| |
|
|
| APP 1
|
| Artes Medical Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0139
|
| Patent Extension Application for Vectibix (panitumumab), U.S. Patent No. 6,235,883
|
| |
|
|
| APP 1
|
| Amgen Fremont Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER
|
| Vol #:
|
| 1
|
| |
|
|
| SUP 1
|
| Amgen Fremont Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| APE 1
|
| P. S. I. International, Inc.
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 1
|
| A. C. S. Federal
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 2
|
| Medical Imaging & Technology Alliance (A Division of NEMA)
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 3
|
| Community MTM Services, Inc.
|
| Vol #:
|
| 7
|
| |
|
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
| |
|
|
| EAPE 28
|
| Hassan, Nasser
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 29
|
| Young, Donna
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 30
|
| Sunshine, Jennifer
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 31
|
| Mayberry, Peter
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 32
|
| Sharav, Vera
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 33
|
| Brueckl, Mark
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 34
|
| Rohe, Paige
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 35
|
| Palmer, Donald
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 36
|
| Gallagher, Rita Munley
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 37
|
| Norden, Janet
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 38
|
| Coster, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 39
|
| Fix, Amy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 40
|
| Lee, Koung
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 41
|
| Copmann, Thomas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 42
|
| Marotta, Robert
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| EAPE 1
|
| Shah, Snehal
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EAPE 2
|
| Winthrop, Sally
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 3
|
| Gross , Mary
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 4
|
| Unger, Monica
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 5
|
| Norden, Janet
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 6
|
| Best, Jeanine
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 7
|
| Karwoski, Claudia
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 8
|
| Hassner Sharav, Vera
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 9
|
| Weaver, Joyce
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 10
|
| Frank, Lesley
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 11
|
| Fix, Amy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 12
|
| Hoerner, Paul
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 13
|
| Piazza-Hepp, Toni
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 14
|
| Copmann, Thomas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 15
|
| Lee, Koung
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 16
|
| Chung, Jean
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 17
|
| Richman, Howard
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 18
|
| Rickman, William
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 19
|
| Aponte, Boris
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 20
|
| Grewal, Renmeet
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 21
|
| Moore, James
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 22
|
| Hetrick, Lauren
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 23
|
| Wolf , Michael
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 24
|
| Van Syckel, Lisa
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0110
|
| To enforce pediatric exclusivity rights for amlodipine
|
| |
|
|
| C 1
|
| Apotex Inc. (formerly TorPharm)
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0111
|
| Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity
|
| |
|
|
| C 1
|
| Apotex Inc. (formerly TorPharm)
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0116
|
| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
|
|
|
|
|
|
| | |
|
|
| C 2
|
| Apotex Inc. (formerly TorPharm)
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0140
|
| Stay final approval and/or effective date of final approval of any 0.4. mg Norethindrone and 35 microgram Ethinyl Estradiol oral chewable tablet product ANDAs unless there is pharmaceutical e
|
|
|
|
|
|
| | |
|
|
| ACK 1
|
| FDA/DDM to Warner Chilcott Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Warner Chilcott Inc.
|
| Vol #:
|
| 1
|
|
|
