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| Dockets Entered
On May 17, 2005
Table of Contents
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| Docket #
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| Title
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| 1982P-0316
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| Reclassify electroconvulsive therapy (ECT) SECTION 513(E)
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| 1994P-0187
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| Modify Ingred Label for In-Store Prepared Take-Out Food
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| 1997N-0484S
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| Human Cellular and Tissue-Based Products
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000V-1221
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| Laser Light Show (Long Island Laser Work)
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2001V-0328
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| Laser Light Show
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0315
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| Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug
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| 2003P-0372
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| Refuse to approve any ANDA for doxycycline hyclate capsules 20mg
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| 2003V-0131
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| Laser Light Show
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| 2004D-0453
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| Compliance Policy Guide Sec. 560.400 - 'Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)'
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| 2004P-0348
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| ANDA for Fluticasone Propionate Nasal Spray, 50 mcg
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| 2004P-0517
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| Stay approval of any ANDAs submitted by Ivax Pharmaceuticals, Inc., CorePharma LLC, or any other party for which CollaGenex's Periostat (doxycycline hyclate 20 mg)
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| 2005M-0191
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| P040034 - DuraSeal Sealant System
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| 2005M-0192
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| P040016 - Boston Scientific Corporation Liberte Monorail and Over-the-Wire Coronary Stent Systems
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| 2005M-0193
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| P030037 - Rithron-XR Coronary Stent System
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2005P-0076
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| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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| 2005P-0127
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| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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| 2005V-0145
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| Laser Light Show
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| 2005V-0165
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| Projector for a Laser Light Show
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| 2005V-0194
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| Laser Light Show
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| LET
148
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| HFD-110 to Innovative Science Solutions, LLC
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| Vol #:
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| 257
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| 1982P-0316
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| Reclassify electroconvulsive therapy (ECT) SECTION 513(E)
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| | | | | | | | |
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| C 822
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| J. Rose
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| Vol #:
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| 35
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| 1994P-0187
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| Modify Ingred Label for In-Store Prepared Take-Out Food
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| LET
2
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| Food Marketing Institute (FMI) and National Grocers Assn
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| Vol #:
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| 1
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| 1997N-0484S
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| Human Cellular and Tissue-Based Products
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| C 498
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| S. Timberlake
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| Vol #:
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| 44
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4331
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| J. Spence
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| Vol #:
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| 320
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| EMC 4332
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| T. Jordan
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| Vol #:
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| 320
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18228
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| J. Corazon
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| Vol #:
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| 516
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 602
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| No signature
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| Vol #:
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| 24
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| 2000V-1221
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| Laser Light Show (Long Island Laser Work)
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| VRA
3
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| HFZ-300 to Long Island Laser Works, Inc.
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| Vol #:
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| 1
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| EMC 13
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| B. Lyle
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| Vol #:
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| 3
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 14429
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| D. Taylor
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| Vol #:
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| 342
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| EMC 14430
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| K. Ratynski
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| Vol #:
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| 342
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| EMC 14431
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| J. Tyson, Jr.
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| Vol #:
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| 342
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| EMC 14432
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| T. Tedesco
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| Vol #:
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| 342
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| EMC 14433
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| A. Davey
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| Vol #:
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| 342
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| EMC 14434
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| G. Estrada
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| Vol #:
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| 342
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| EMC 14435
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| A. Brister
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| Vol #:
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| 342
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| EMC 14436
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| M. Hamm
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| Vol #:
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| 342
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| EMC 14437
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| L. Steeves
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| Vol #:
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| 342
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| EMC 14438
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| J. Fulton
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| Vol #:
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| 342
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| EMC 14439
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| S. McDavid
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| Vol #:
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| 342
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| EMC 14440
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| M. Robinson
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| Vol #:
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| 342
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| EMC 14441
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| J. Pitt
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| Vol #:
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| 342
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| EMC 14442
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| P. McCarthy
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| Vol #:
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| 342
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| EMC 14443
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| M. Morris
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| Vol #:
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| 342
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| EMC 3169
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| A. DeLong
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| Vol #:
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| 261
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| 2001V-0328
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| Laser Light Show
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| VRA
2
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| HFZ-200 to Stim-U-Lights
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| Vol #:
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| 1
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 458
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| Calorie Control Council
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| Vol #:
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| 7
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| EMC 459
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| Calorie Control Council
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| Vol #:
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| 7
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 786
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| D. Hirchak
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| Vol #:
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| 11
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| C 155
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| D. Donnell
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| Vol #:
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| 9
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| C 156
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| Dr and Mrs. M. Sinclair
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| Vol #:
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| 9
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| C 157
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| B. Preiss
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| Vol #:
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| 9
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| C 158
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| C. McClintock
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| Vol #:
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| 9
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| C 159
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| R and C Daniels
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| Vol #:
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| 9
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| C 160
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| E. Jonas
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| Vol #:
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| 9
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| C 161
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| M. Hass
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| Vol #:
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| 9
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| C 162
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| C. Link
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| Vol #:
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| 9
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| C 163
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| W. Gilmore
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| Vol #:
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| 9
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| C 164
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| R. Perna
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| Vol #:
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| 9
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| C 165
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| K. McCaskey
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| Vol #:
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| 9
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| C 166
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| S. Prolman, Esq
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| Vol #:
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| 9
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| C 167
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| N. Collins
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| Vol #:
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| 9
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| 2003P-0315
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| Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug
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|
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| PDN
1
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| HF-22 to CollaGenex Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2003P-0372
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| Refuse to approve any ANDA for doxycycline hyclate capsules 20mg
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| PDN
1
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| HF-22 to CollaGenex Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2003V-0131
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| Laser Light Show
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| EXP 1
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| Laser Design Productions
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| Vol #:
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| 1
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| 2004D-0453
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| Compliance Policy Guide Sec. 560.400 - 'Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)'
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| C
7
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| Australian Government
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| Vol #:
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| 1
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| C
2
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| American Academy of Orthopaedic Surgeons (AAOS)
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| Vol #:
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| 1
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| C
3
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| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 1
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| C
4
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| National Electrical Manufacturers Assn (NEMA)
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| Vol #:
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| 1
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| |
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| 2004P-0348
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| ANDA for Fluticasone Propionate Nasal Spray, 50 mcg
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| SUP
1
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| Frommer Lawrence & Haug LLP
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| Vol #:
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| 1
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| 2004P-0517
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| Stay approval of any ANDAs submitted by Ivax Pharmaceuticals, Inc., CorePharma LLC, or any other party for which CollaGenex's Periostat (doxycycline hyclate 20 mg)
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| PDN
1
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| HF-22 to CollaGenex Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| C
4
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| Memorial Blood Centers
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| Vol #:
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| 1
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| 2005M-0191
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| P040034 - DuraSeal Sealant System
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| AAV
1
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| Confluent Surgical, Inc.
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| Vol #:
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| 1
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| 2005M-0192
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| P040016 - Boston Scientific Corporation Liberte Monorail and Over-the-Wire Coronary Stent Systems
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| AAV
1
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| Boston Scientific Corporation
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| Vol #:
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| 1
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| 2005M-0193
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| P030037 - Rithron-XR Coronary Stent System
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| AAV
1
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| BIOTRONIK, Inc.
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| Vol #:
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| 1
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| |
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| C 2
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| H. Gharib, M.D., M.A.C.E.
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| Vol #:
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| 1
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| C 3
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| H. Lando, MD
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| Vol #:
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| 1
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| 2005P-0076
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| OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
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| CR
1
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| Purdue Pharma L.P. (Purdue)
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| Vol #:
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| 1
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| 2005P-0127
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| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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| C
1
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| Kali Laboratories, Inc. (Kali)
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| Vol #:
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| 2
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| 2005V-0145
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| Laser Light Show
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| VRA
1
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| HFZ-200 to Disneyland Resort
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| Vol #:
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| 1
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| 2005V-0165
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| Projector for a Laser Light Show
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| VRA
1
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| HFZ-200 to EMC Inc., DBA The Boiler Room
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| Vol #:
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| 1
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| 2005V-0194
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| Laser Light Show
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| ACK
1
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| HFA-305 to Ogden Dinosaur Park and Museum
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| Vol #:
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| 1
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| VAR
1
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| Ogden Dinosaur Park and Museum
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| Vol #:
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| 1
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