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| Dockets Entered
On January 25, 2006
Table of Contents
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| Docket #
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| Title
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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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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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0395
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| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
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| 2005N-0396
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| Agency Information Collection Activities: Proposed Collection; Guidance on Formal Dispute Resolution; Appeals Above the Division Level
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2006E-0050
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| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
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| 2006P-0052
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| Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| BKG
1
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| Background Information Refs 1 - 15
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| Vol #:
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| 97
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| NPR
2
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| FDA
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| Vol #:
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| 97
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 624
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| D. Taylor, M.D.
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| Vol #:
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| 24
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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 1303
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| J. Pearce
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| Vol #:
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| 6
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| EMC 1304
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| A. McBain
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| Vol #:
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| 6
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| EMC 237
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| J. Caldwell
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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
591
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| Calorie Control Council
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| Vol #:
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| 9
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| EMC 592
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 593
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| Mission Possible International
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| Vol #:
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| 6
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| EMC 594
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 595
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| Mission Possible International
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| Vol #:
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| 6
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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 1204
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| R. Jeter
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| Vol #:
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| 12
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| EMC 1205
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| C. Greene
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| Vol #:
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| 12
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| EMC 1206
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| M. O'Neal
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| Vol #:
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| 12
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| EMC 1207
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| C. Hall
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| Vol #:
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| 12
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| EMC 1208
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| R. Perez
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| Vol #:
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| 12
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS 21
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| HFA-305
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| Vol #:
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| 10
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| OR 18
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| HF-3
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| Vol #:
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| 10
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| EMC 78
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| A. Isaak
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| Vol #:
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| 4
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| EMC 79
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| E. Craig
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| Vol #:
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| 4
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| EMC 80
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| J. Bailey
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| Vol #:
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| 4
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| EMC 81
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| D. Swanson
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| Vol #:
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| 4
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| EMC 82
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| J. Harcketts
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| Vol #:
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| 4
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| EMC 83
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| R. Arcuri
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| Vol #:
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| 4
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| EMC 84
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| I. Ackerman
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| Vol #:
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| 4
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| EMC 85
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| J. Moniz
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| Vol #:
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| 4
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| EMC 86
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| C and G O'Leary
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| Vol #:
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| 4
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| EMC 87
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| C and G O'Leary
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| Vol #:
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| 4
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| EMC 88
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| J. Graham
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| Vol #:
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| 4
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| EMC 89
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| K. Britton
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| Vol #:
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| 4
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| EMC 90
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| K. Orchard
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| Vol #:
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| 4
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| EMC 91
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| H. Mortenson, MSPH
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| Vol #:
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| 4
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| EMC 92
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| W. Bailey
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| Vol #:
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| 4
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| EMC 93
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| D. Sherman
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| Vol #:
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| 4
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| 2005N-0395
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| Agency Information Collection: Guidance on Formal Meetings with Sponsors and Applicants for PDUFA
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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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| 2005N-0396
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| Agency Information Collection Activities: Proposed Collection; Guidance on Formal Dispute Resolution; Appeals Above the Division Level
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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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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma- Hydroxybutyric Acid; Ketamine;
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| LET
1
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| Hyman, Phelps & McNamara, P.C.
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| Vol #:
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| 2
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| LET
2
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| International Harm Reduction Association et al
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| Vol #:
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| 2
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| EC
161
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| P Glaze
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| Vol #:
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| 4
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| EC
162
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| Mrs. Deborah Schafer
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| Vol #:
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| 4
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| EC
163
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| Mrs. Rae Monsere
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| Vol #:
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| 4
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| EC
164
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| Ms. Susan Antonides
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| Vol #:
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| 4
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| EC
165
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| Mrs. Twila Wilt
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| Vol #:
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| 4
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| EC
166
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| Mrs. Linda Cordon
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| Vol #:
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| 4
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| EC
167
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| Mrs. Karen Fenwick
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| Vol #:
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| 4
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| EC
168
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| Ms. adrienne elman
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| Vol #:
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| 4
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| EC
169
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| Mrs. Denise Bankston
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| Vol #:
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| 4
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| EC
170
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| Ms. Julie Sohnly,RN,HNC-BC
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| Vol #:
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| 4
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| EC
171
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| Mrs. debra neal
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| Vol #:
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| 4
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| EC
172
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| Dr. Rexann Wagner
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| Vol #:
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| 4
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| EC
173
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| none
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| Vol #:
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| 4
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| EC
174
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| Mrs. Kristine Mitchell
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| Vol #:
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| 4
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| EC
175
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| Mrs. Diana Wright
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| Vol #:
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| 4
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| EC 176
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| Consumer
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| Vol #:
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| 4
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| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
|
|
|
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| C
2
Attachments
|
| Precept Foods, LLC (Precept Foods)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2006E-0050
|
| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
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|
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| APP
1
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| Amylin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent and Trademark Office
|
| Vol #:
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| 1
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| 2006P-0052
|
| Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
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|
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| ACK
1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
|
| 1
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| CP
1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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