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| Dockets Entered
On May 31, 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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| 1994G-0237
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| Safe Use In Food Triglyceride Containing Caprylic & Capric
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| |
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| 1997N-0484S
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| Human Cellular and Tissue-Based Products
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| 1997N-0484T
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| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
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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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| 2000N-0504
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| Egg Safety Action Plan
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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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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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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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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2005N-0178
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
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| 2005P-0139
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| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| 2005P-0212
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| ANDA suitability petition for Lamotrigine 50 milligram and 250 milligram oral tablets
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| 2005P-0213
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| To change the classification of EEG electrodes currently classified as class II and requiring 510K approvals\
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| SUP
55
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| Innovative Science Solutions, LLC
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| Vol #:
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| 257
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| 1994G-0237
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| Safe Use In Food Triglyceride Containing Caprylic & Capric
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| SUP
2
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| Stepan Company
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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
499
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| The Institute for Transfusion Medicine
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| Vol #:
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| 44
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| 1997N-0484T
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| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
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| EMC 1
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| A. Carrillo, PhD
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| Vol #:
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| 1
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| EMC 2
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| A. Carrillo
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| Vol #:
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| 1
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| | | | | | | | |
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| C 7484
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| E. Sturhan
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| Vol #:
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| 319
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| C 7485
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| M. Roberts
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| Vol #:
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| 319
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| C 7486
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| J. Williams
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| Vol #:
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| 319
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18230
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| E. Skalwold
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| Vol #:
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| 516
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| 2000N-0504
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| Egg Safety Action Plan
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| EMC
1908
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| United Egg Producers (UEP)
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| Vol #:
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| 31
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 14447
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| J. Welan
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| Vol #:
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| 342
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| EMC 14448
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| V. Barrett
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| Vol #:
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| 342
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| EMC 14449
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| R. Lipshutz
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| Vol #:
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| 342
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| EMC 14450
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| E. Skaff
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| Vol #:
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| 342
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| EMC 14451
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| H. McDermott
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| Vol #:
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| 342
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| EMC 14452
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| C. Thaxton
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| Vol #:
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| 342
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| EMC 14453
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| M. McComsey
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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 3170
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| J. Annecone
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| Vol #:
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| 261
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1265
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| B. Rex
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| Vol #:
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| 5
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 216
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| E. Inghram
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| Vol #:
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| 4
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 465
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| Mission Possible International
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| Vol #:
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| 7
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| EMC 466
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| Mission Possible International
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| Vol #:
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| 7
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| EMC 467
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| Mission Possible International
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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 795
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| C. Chang
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| Vol #:
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| 11
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| EMC 796
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| L. Wright
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| Vol #:
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| 11
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| EMC 797
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| L. Bird
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| Vol #:
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| 11
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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|
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| N
3
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| FDA
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| Vol #:
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| C 34
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| J. Ackman
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| Vol #:
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| 1
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| C
35
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| Texas Department of State Health Services
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| Vol #:
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| 1
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| EMC 286
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| L. Rusen
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| Vol #:
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| 3
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| 2004P-0113
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| immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney/failure damage occur
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|
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| M
1
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| Review of AERS Reports
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| Vol #:
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| 1
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|
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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|
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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|
|
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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|
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| GDL
1
|
| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| EMC 1
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| D. Palmisano
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| Vol #:
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| 1
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| 2005N-0178
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005P-0139
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| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| EMC 487
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| B. Fitzpatrick
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| Vol #:
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| 3
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| EMC 488
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| C. Neil
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| Vol #:
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| 3
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| EMC 489
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| H. Emerson
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| Vol #:
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| 3
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| EMC 490
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| G. Hoare, SL
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| Vol #:
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| 3
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| EMC 491
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| M. Koko
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| Vol #:
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| 3
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| EMC 492
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| F. Pappas
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| Vol #:
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| 3
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| EMC 493
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| D. Kloempken
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| Vol #:
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| 3
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| EMC 494
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| S. Barker
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| Vol #:
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| 3
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| EMC 495
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| J. Hopey
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| Vol #:
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| 3
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| EMC 496
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| J. Darrar
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| Vol #:
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| 3
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| EMC 497
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| H. Miller, M.D.
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| Vol #:
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| 3
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| EMC 498
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| C. Duda
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| Vol #:
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| 3
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| EMC 499
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| H. Ruderman
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| Vol #:
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| 3
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| EMC 500
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| C. Cass
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| Vol #:
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| 3
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| EMC 501
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| A. Hellgren
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| Vol #:
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| 3
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| EMC 502
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| R. Yanai
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| Vol #:
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| 3
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| EMC 503
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| J. Moore
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| Vol #:
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| 3
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