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| Dockets Entered
On January 25, 2005
Table of Contents
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| Docket #
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| Title
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| 1978N-0301
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| OTC External Analgesic Drug Products
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| 1993F-0357
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| Safe use of Source of Fast (high energy) Neutrons
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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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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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001V-0157
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| Slick Productions laser light show with Lasergraphix Lgx-1000 Ar Projector
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| 2001V-0328
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| Laser Light Show
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| 2003N-0324B
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| Bacitracin methylene disalicylate single-ingredient Type A Medicated articles
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| 2003N-0324O
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| Oxytetracycline and neomycin fixed-combination Type A medicated articles
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0459
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| Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
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| 2004D-0462
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| Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes
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| 2004D-0468
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| Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| 2004N-0480
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| The Minor Use & Minor Species (MUMS) Animal Health Act
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| 2004P-0340
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| action on regulation of generic transdermal fentanyl delivery system, and new product approvals for transdermal fentanyl products
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| 2004P-0472
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| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
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| 2004P-0485
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| require the source of the dietary ingredient lycopene to be identified as from tomato,fungus, or synthetic
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| 2004P-0506
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| fentanyl transdermal products reduce the potential for abuse of certain types of these products
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| 2004P-0540
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| Don't approve any new or pending ANDA for generic fentanyl transdermal product
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| 2005P-0034
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| Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market
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| 2005P-0035
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| authorizing Phelon Parts, Inc., to purchase and use nitrous oxide gas as part of the manufacturing process of the Phelon Group
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| 2005P-0037
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| regarding product of estradiol vaginal cream
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| 1978N-0301
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| OTC External Analgesic Drug Products
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| LET
90
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| Hobart Laboratories, Inc.
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| Vol #:
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| 105
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| 1993F-0357
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| Safe use of Source of Fast (high energy) Neutrons
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| C 1
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| Number not used
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| 1
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| C
68
Attachment
A
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| Association for Dressing and Sauces (ADS)
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| Vol #:
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| 7
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| C
69
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| Schwan Food Company
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| Vol #:
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| 7
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| C
70
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| American Bakers Association (ABA)
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| Vol #:
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| 7
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| C
71
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| National Food Processors Association (NFPA)
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| Vol #:
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| 7
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| C
85
Attachment
A
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| Association for Dressings and Sauces (ADS)
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| Vol #:
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| 9
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| C
86
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| Schwan Food Company
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| Vol #:
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| 9
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| C
87
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| American Bakers Association (ABA)
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| Vol #:
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| 9
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| C
88
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| National Food Processors Association (NFPA)
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| Vol #:
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| 9
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
15382
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15383
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15384
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15385
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15386
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15387
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15388
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15389
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15390
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15391
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15392
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15393
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15394
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| NBTY Inc.
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| Vol #:
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| 135
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| LET
15395
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| Enzymatic Therapy
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| Vol #:
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| 135
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| LET
15396
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| Enzymatic Therapy
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| Vol #:
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| 135
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| LET
15397
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| Enzymatic Therapy
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| Vol #:
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| 135
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| LET
15398
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| GAIA Herbs
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| Vol #:
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| 135
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| LET
15399
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| Advocare International, L.P.
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| Vol #:
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| 135
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| LET
15400
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| Enzymatic Therapy
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| Vol #:
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| 135
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| LET
15401
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| Enzymatic Therapy
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| Vol #:
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| 135
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| LET
15402
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| Enzymatic Therapy
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| Vol #:
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| 135
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7469
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| T. Langsam
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| Vol #:
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| 320
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| C 7470
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| V. Kahn
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| Vol #:
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| 319
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| C 2050
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| C. Abraham
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| Vol #:
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| 300
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| C 2051
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| M. Weddletan
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| Vol #:
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| 300
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| 2001V-0157
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| Slick Productions laser light show with Lasergraphix Lgx-1000 Ar Projector
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| EXP
1
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| Slick Productions
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| Vol #:
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| 1
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| 2001V-0328
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| Laser Light Show
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| EXP
1
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| Stimulights Lasers
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| Vol #:
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| 1
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| C 1
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| Public Citizen
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| Vol #:
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| 1
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| 2003N-0324B
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| Bacitracin methylene disalicylate single-ingredient Type A Medicated articles
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| LET
5
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| HF-1
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| Vol #:
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| 1
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| 2003N-0324O
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| Oxytetracycline and neomycin fixed-combination Type A medicated articles
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| LET
5
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| HF-1
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| Vol #:
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| 1
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| C
38
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| Order of Malta Federal Association, USA
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| Vol #:
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| 6
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| C
41
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| American Hospital Assn (AHA), American Society for Healthcare Engineering (ASHE), and ASHRM
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| Vol #:
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| 3
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| |
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| 2004D-0459
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| Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
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| C
5
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
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| C
6
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| Pfizer, Inc.
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| Vol #:
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| 1
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| 2004D-0462
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| Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes
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| C
1
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| Sangart, Inc and the University of California, San Diego
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| Vol #:
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| 1
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| 2004D-0468
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| Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
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| C
1
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| Animal Health Institute (AHI)
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| Vol #:
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| 1
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C
5
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| Herbalife International, Inc. (Herbalife)
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| Vol #:
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| 5
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| C 6
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| D. Croix
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| Vol #:
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| 5
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| 2004N-0479
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| Draft Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals; Availability
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| C 1
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| G. Scott, DVM
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| Vol #:
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| 1
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| 2004N-0480
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| The Minor Use & Minor Species (MUMS) Animal Health Act
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| C 2
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| M. Favre
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| Vol #:
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| 1
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| C 3
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| H. Warrick
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| Vol #:
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| 1
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| |
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| 2004P-0340
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| action on regulation of generic transdermal fentanyl delivery system, and new product approvals for transdermal fentanyl products
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| C
3
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| Lavipharm Laboratories (Lavipharm)
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| Vol #:
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| 1
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| 2004P-0472
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| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
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| C
5
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| Lavipharm Laboratories (Lavipharm)
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| Vol #:
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| 2
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| C
6
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| Noven Pharmaceuticals, Inc. (Noven)
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| Vol #:
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| 2
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| 2004P-0485
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| require the source of the dietary ingredient lycopene to be identified as from tomato,fungus, or synthetic
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| C
1
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| Hyman, Phelps & McNamara, PC
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| Vol #:
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| 1
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| 2004P-0506
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| fentanyl transdermal products reduce the potential for abuse of certain types of these products
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| C
3
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| Lavipharm Laboratories (Lavipharm
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| Vol #:
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| 2
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| 2004P-0540
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| Don't approve any new or pending ANDA for generic fentanyl transdermal product
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| C
3
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| Lavipharm Laboratories (Lavipharm
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| Vol #:
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| 1
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| 2005P-0034
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| Remove the COX-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) from the Market
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| ACK
1
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| HFA-305 to Public Citizen Health Research Group
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| Vol #:
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| 1
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| CP
1
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| Public Citizen Health Research Group
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| Vol #:
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| 1
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| 2005P-0035
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| authorizing Phelon Parts, Inc., to purchase and use nitrous oxide gas as part of the manufacturing process of the Phelon Group
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| CP
1
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| Phelon Parts, Inc.
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| Vol #:
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| 1
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| 2005P-0037
|
| regarding product of estradiol vaginal cream
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| CP
1
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| Warner Chilcott Inc.
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| Vol #:
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| 1
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