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| Dockets Entered
On October 6, 2004
Table of Contents
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| Docket #
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| Title
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| 1981N-0033P
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| Antigingivitis & Antiplaque-Related Claims
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| 1990N-0172
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| Revise Medical Device CGMP Regulation
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1996P-0418
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| Reduce the Precense of Salmonella Enteritidis in Shell Eggs
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| 1997P-0197
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| Require that warning labels about risks of salmonella enteri
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1998P-0203
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| Eliminate Forced Molting of Laying Birds
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2003P-0479
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| Allow importation of Canadian versions of drugs that are approved to the United States
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| 2003P-0548
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| Determination whether Dexamethasone Acetate Injection withdrawn for Safety Reasons
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| 2004D-0193
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| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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| 2004D-0414
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| FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004P-0148
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| ANDA Suitability for Oxycodone Hydrochloride 5 mg, 10 mg and 20 mg tablets
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| 2004P-0152
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| ANDA Suitability for Hydromorphone Hydrochloride Tablets 2 mg and 4 mg dosage strengths
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| 2004P-0195
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| ANDA Suitability for Divalproex Sodium Extended-Release Tablets, 750 mg
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| 2004P-0452
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| Regulate the use of coding on food labels
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| 1981N-0033P
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| Antigingivitis & Antiplaque-Related Claims
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| C
25
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| Procter & Gamble
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| Vol #:
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| 88
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| C
26
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| Colgate-Palmolive Company
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| Vol #:
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| 90
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| SUP
4
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| Ciba Specialty Chemicals Corporation (Ciba)
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| Vol #:
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| 89
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| SUP
5
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| Ciba Speciality Chemicals Corporation (Ciba)
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| Vol #:
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| 86
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| 1990N-0172
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| Revise Medical Device CGMP Regulation
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| ANS 6
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| HFW-1 to Honorable Slade Gorton
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| Vol #:
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| 18
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| BKG 5
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| Background material
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| Vol #:
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| 21
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
30
Hospital Info.
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 30
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| SUP
31
Hospital Info.
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 35
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| SUP
32
Hospital Info.
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 36
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
236
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| Fuji Chemical Industry Co., Ltd
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| Vol #:
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| 170
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| RPT
237
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| U S Nutraceuticals, LLC
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| Vol #:
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| 172
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| 1996P-0418
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| Reduce the Precense of Salmonella Enteritidis in Shell Eggs
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| C 828
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| R. Lavosky
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| Vol #:
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| 33
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| C 829
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| K. Hastings
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| Vol #:
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| 33
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| C 830
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| D. Cedar, RD
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| Vol #:
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| 33
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| 1997P-0197
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| Require that warning labels about risks of salmonella enteri
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| C 853
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| R. Lavosky
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| Vol #:
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| 32
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| C 854
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| K. Hastings
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| Vol #:
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| 32
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| C 855
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| D. Cedar, RD
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| Vol #:
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| 32
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7453
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| D. Brown
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| Vol #:
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| 319
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| C 7454
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| R. Capozzelli
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| Vol #:
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| 319
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| C 7455
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| K. Nguyen
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| Vol #:
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| 319
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| C 7456
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| J. Policoff
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| Vol #:
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| 319
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| C 7457
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| S and H Wyck
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| Vol #:
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| 319
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| 1998P-0203
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| Eliminate Forced Molting of Laying Birds
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| C 1963
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| R. Lavosky
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| Vol #:
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| 47
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| C 1964
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| K. Hastings
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| Vol #:
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| 47
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| C 1965
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| D. Cedar, RD
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| Vol #:
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| 47
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| C 69
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| Eligible
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| Vol #:
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| 3
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| 2000N-0504
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| Egg Safety Action Plan
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| C 126
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| R. Lavosky
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| Vol #:
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| 10
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| C 127
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| K. Hastings
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| Vol #:
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| 10
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| C 128
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| D. Cedar, RD
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| Vol #:
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| 10
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 553
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 554
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 555
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 556
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 557
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 558
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 559
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 560
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 561
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 562
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 563
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 564
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 565
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 566
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 567
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 568
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 569
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 570
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 571
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 572
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 573
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 574
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 575
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 576
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 577
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 578
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 579
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 580
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 581
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 582
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 583
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 584
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 585
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 586
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 587
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 588
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 589
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 590
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 591
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 592
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 593
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 594
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 595
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| EXB 596
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| Center for Veterinary Medicine
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| Vol #:
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| 436
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| 2003P-0479
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| Allow importation of Canadian versions of drugs that are approved to the United States
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| C 21
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| M. Piere
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| Vol #:
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| 1
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| C 22
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| A. Proehl
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| Vol #:
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| 1
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| C 23
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| Eligible
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| Vol #:
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| 1
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| C 24
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| A. Zoger
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| Vol #:
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| 1
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| C 25
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| L. Lupa
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| Vol #:
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| 1
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| C 26
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| P. Proehl
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| Vol #:
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| 1
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| 2003P-0548
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| Determination whether Dexamethasone Acetate Injection withdrawn for Safety Reasons
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|
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| ANS
1
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| HFD-7 to Gray Cary
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| Vol #:
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| 1
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| 2004D-0193
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| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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| C
19
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| Alabama Eye Bank
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| Vol #:
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| 1
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| 2004D-0414
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| FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
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|
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| BKG 1
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| Background material
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| Vol #:
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| 2
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| C 40
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| D. Uhlman
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| Vol #:
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| 8
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| C 41
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| J. Aragon
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| Vol #:
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| 8
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| C 42
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| L. Dixon
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| Vol #:
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| 8
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| C 43
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| J. Shakman
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| Vol #:
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| 8
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| C 44
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| M. Prendergast
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| Vol #:
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| 8
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| C 45
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| S. Jarvi
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| Vol #:
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| 8
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| C 46
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| P. Dasgupta
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| Vol #:
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| 8
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| C 47
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| H. Thompson
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| Vol #:
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| 8
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| C
48
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| Farm Sanctuary
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| Vol #:
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| 8
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| C 49
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| S. Edmondson
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| Vol #:
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| 8
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| C 50
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| M. Moll
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| Vol #:
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| 8
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| C 51
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| Ginece Jones
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| Vol #:
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| 8
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| C 52
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| Eligible
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| Vol #:
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| 8
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| C 53
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| B. Frey
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| Vol #:
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| 8
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| C 54
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| K. Kindel
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| Vol #:
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| 8
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| C 55
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| N. Baumgardner
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| Vol #:
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| 8
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| C 56
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| J. Tolpin
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| Vol #:
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| 8
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| C 57
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| C. Clond
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| Vol #:
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| 8
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| C 95
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| A. Kasper
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| Vol #:
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| 12
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| C 96
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| C. Richard
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| Vol #:
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| 12
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| C 97
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| W. Sims
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| Vol #:
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| 12
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| C 98
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| M. Yeary
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| Vol #:
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| 12
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| C
99
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| National Renderers Assn (NRA) and Animal Protein Producers Industry (APPI)
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| Vol #:
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| 12
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| C 100
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| D. Church
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| Vol #:
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| 12
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| 2004P-0148
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| ANDA Suitability for Oxycodone Hydrochloride 5 mg, 10 mg and 20 mg tablets
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| PAV
1
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| HFD-600 to The Weinberg Group Inc.
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| Vol #:
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| 1
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| 2004P-0152
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| ANDA Suitability for Hydromorphone Hydrochloride Tablets 2 mg and 4 mg dosage strengths
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| PAV
1
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| HFD-600 to The Weinberg Group Inc.
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| Vol #:
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| 1
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| 2004P-0195
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| ANDA Suitability for Divalproex Sodium Extended-Release Tablets, 750 mg
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2004P-0452
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| Regulate the use of coding on food labels
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| ACK 1
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| HFA-305 to Bunny Abraham
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| Vol #:
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| 1
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| CP 1
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| Bunny Abraham
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| Vol #:
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| 1
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