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| Dockets Entered
On June 23, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| |
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| |
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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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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| |
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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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| 2004E-0413
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| Patent Term Extension for CIALIS (tadalafil), U.S. Patent No. 5,859, 006
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| 2004E-0444
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| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
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| |
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| |
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| 2005N-0343
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| Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| |
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| 2005N-0457
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized as Safe Exemption Based on a Generally Recognized as Safe Determination
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| 2005P-0295
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| Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup
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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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| |
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| 2006M-0009
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| P020001 - STAN S31 Fetal Heart Monitor, Approved 11/1/05
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| 2006M-0014
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| St. Francis Medical Technologies, Inc, Premarket Approval for X STOP Interspinous Process Decompression System, P040001
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| 2006M-0015
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| Biomet Manufacturing Corporation, Premarket Approval of C2a-Taper Acetabular System, P050009
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| 2006M-0075
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| P020024 - AMPLATZER Duct Occluder and 180 Degree Delivery System, Approved 5/14/03
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| 2006M-0163
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| H040005 - Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set, Karl Storz Rigid TTTS Fetoscopy Instrument Set with 0 or 12 degree scope, and Karl Storz Rigid TTTS Fetoscopy Instrument Set with 30 degr
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| 2006N-0237
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
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| 2006N-0239
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
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| 2006O-0232
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
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| 2006P-0265
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| to permit an ANDA Suitability for Cefdinir
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| |
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| 2006V-0257
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| Laser Light Show
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| |
|
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
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| LET 17949
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| Sunrider International
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| Vol #:
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| 165
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| LET 17950
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| Sunrider International
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| Vol #:
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| 165
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| LET 17951
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| Sunrider International
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| Vol #:
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| 165
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| |
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| LET 17952
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| Sunrider International
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| Vol #:
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| 165
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| |
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| LET 17953
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| Sunrider International
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| Vol #:
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| 165
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| |
|
|
| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| EMC 29
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| K. Turner
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| Vol #:
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| 3
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| EMC 30
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| A. Gallagher
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| Vol #:
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| 3
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| EMC 31
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| S. Johnson
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| Vol #:
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| 3
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| EMC 32
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| K. Murray
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| Vol #:
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| 3
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| EMC 33
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| K. Martinez
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| Vol #:
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| 3
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| EMC 34
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| C. Hume
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| Vol #:
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| 3
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| EMC 35
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| K. Burroughs
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| Vol #:
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| 3
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| EMC 36
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| C. Opfer
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| Vol #:
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| 3
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| EMC 37
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| P. Pages
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| Vol #:
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| 3
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| EMC 38
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| D. Erenberg
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| Vol #:
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| 3
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| EMC 39
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| T. Eannarino
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| Vol #:
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| 3
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| EMC 40
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| D. Hall
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| Vol #:
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| 3
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| EMC 41
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| P. Gronbeck
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| Vol #:
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| 3
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| EMC 42
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| M. Szymanskyj
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| Vol #:
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| 3
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| EMC 43
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| M. Armstrong
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| Vol #:
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| 3
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| EMC 44
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| J. Pappas, III
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| Vol #:
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| 3
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| EMC 45
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| J. McKain
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| Vol #:
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| 3
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| EMC 46
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| C. Hensel
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| Vol #:
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| 3
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| EMC 47
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| P. Morello
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| Vol #:
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| 3
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| EMC 48
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| D. Toth
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| Vol #:
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| 3
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| EMC 49
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| C. Caccia
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| Vol #:
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| 3
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| EMC 50
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| D. Dougherty, RD, LD
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| Vol #:
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| 3
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| EMC 51
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| R. Mangels, PhD,RD,LD,FADA
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| Vol #:
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| 3
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| EMC 52
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| C. Guier
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| Vol #:
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| 3
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| EMC 53
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| D. Birkholz
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| Vol #:
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| 3
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| EMC 54
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| J. DiFranza
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| Vol #:
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| 3
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| EMC 55
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| J. Westland
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| Vol #:
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| 3
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| EMC 56
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| G. Eldridge
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| Vol #:
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| 3
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| EMC 57
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| S. Kepner
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| Vol #:
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| 3
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| EMC 58
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| M. Bennett
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| Vol #:
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| 3
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| EMC 59
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| R. Herman
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| Vol #:
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| 3
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| EMC 60
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| C. Sandy
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| Vol #:
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| 3
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| EMC 61
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| M. O'Connell
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| Vol #:
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| 3
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| EMC 62
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| S. Polk
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| Vol #:
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| 3
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| EMC 63
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| J. Sergent
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| Vol #:
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| 3
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| EMC 64
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| K. McCarthy
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| Vol #:
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| 3
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| EMC 65
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| L. Toma
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| Vol #:
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| 3
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| EMC 66
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| P. GArdner
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| Vol #:
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| 3
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| EMC 67
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| E. Hillen
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| Vol #:
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| 3
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| EMC 68
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| M. Aponte
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| Vol #:
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| 3
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| EMC 69
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| M. McNamara
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| Vol #:
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| 3
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| EMC 70
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| N. Lawler
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| Vol #:
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| 3
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| EMC 71
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| J. Rebar
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| Vol #:
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| 3
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| EMC 72
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| T. Aldridge
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| Vol #:
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| 3
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| EMC 73
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| V. McGowan
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| Vol #:
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| 3
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| EMC 74
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| L. Young
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| Vol #:
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| 3
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| EMC 75
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| R. Winter
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| Vol #:
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| 3
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| EMC 76
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| C. Young
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| Vol #:
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| 3
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| EMC 77
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| C. LaVigne
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| Vol #:
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| 3
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| EMC 78
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| B. Burmeister
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| Vol #:
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| 3
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| EMC 79
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| M. Carroll
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| Vol #:
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| 3
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| EMC 80
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| A. Boutcher
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| Vol #:
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| 3
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| EMC 81
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| K. Corbin
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| Vol #:
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| 3
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| EMC 82
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| K. McAnnally
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| Vol #:
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| 3
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| EMC 83
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| R> Imuta
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| Vol #:
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| 3
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| EMC 84
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| M. Porter, RD
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| Vol #:
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| 3
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| EMC 85
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| V. Davis
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| Vol #:
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| 3
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| EMC 86
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| H. Gershon
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| Vol #:
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| 3
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| EMC 87
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| J. Dickerson
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| Vol #:
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| 3
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| EMC 88
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| E. Lowell
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| Vol #:
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| 3
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| EMC 89
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| C. Worthy
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| Vol #:
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| 3
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| EMC 90
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| G and J Arnold
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| Vol #:
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| 3
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| EMC 91
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| E. Bennett
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| Vol #:
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| 3
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| EMC 92
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| D. Compain
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| Vol #:
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| 3
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| EMC 93
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| P. Bromley
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| Vol #:
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| 3
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| |
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| EMC 94
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| V. Cardinale
|
| Vol #:
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| 3
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| |
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| EMC 95
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| M. King
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| Vol #:
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| 3
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| EMC 96
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| B. Flowers
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| Vol #:
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| 3
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| EMC 97
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| L. CHambers
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| Vol #:
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| 3
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| EMC 98
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| D. Vice
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| Vol #:
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| 3
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| EMC 99
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| G. Holden
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| Vol #:
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| 3
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| EMC 100
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| E. Kwolek
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| Vol #:
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| 3
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| EMC 101
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| J. Thevegan
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| Vol #:
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| 3
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| EMC 102
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| B. Searles
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| Vol #:
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| 3
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| |
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| EMC 103
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| T. Grande
|
| Vol #:
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| 3
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| EMC 104
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| C. Lamke
|
| Vol #:
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| 3
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| |
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| EMC 105
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| K. Thomas
|
| Vol #:
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| 3
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| | | | | | | | |
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| |
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| EMC 106
|
| P. Young
|
| Vol #:
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| 3
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| |
|
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| EMC 107
|
| J. Cecil
|
| Vol #:
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| 3
|
|
| |
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 645
|
| R> Colquitt
|
| Vol #:
|
| 24
|
| |
|
|
| EMC 646
|
| C. Sloan
|
| Vol #:
|
| 24
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| EMC 1325
|
| Eligible
|
| Vol #:
|
| 6
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 662
|
| Mission Possible International
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 663
|
| Mission Possible International
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 664
|
| Mission Possible International
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 665
|
| Mission Possible International
|
| Vol #:
|
| 9
|
| |
|
|
| EMC 666
|
| R. Murray
|
| Vol #:
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| 9
|
|
| |
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 1304
|
| J. Moore
|
| Vol #:
|
| 12
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| |
|
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| EMC 1305
|
| K. Simi
|
| Vol #:
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| 12
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| |
|
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| EMC 1306
|
| No signature
|
| Vol #:
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| 12
|
| |
|
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| EMC 1307
|
| No signature
|
| Vol #:
|
| 12
|
| |
|
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| EMC 1308
|
| A. Garfall
|
| Vol #:
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| 12
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| |
|
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| EMC 1309
|
| E and K Lupien
|
| Vol #:
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| 12
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| |
|
|
| EMC 1310
|
| W. Cecil
|
| Vol #:
|
| 12
|
| |
|
|
| 2004E-0413
|
| Patent Term Extension for CIALIS (tadalafil), U.S. Patent No. 5,859, 006
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0444
|
| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
| |
|
|
| CS 12
|
| FDA/DDM
|
| Vol #:
|
| 4
|
| |
|
|
| OR 12
|
| Administrative Law Judge
|
| Vol #:
|
| 4
|
| |
|
|
| 2005N-0343
|
| Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
|
| |
|
|
| NAL 2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS 2
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
| 2005N-0374
|
| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
|
| |
|
|
| EMC 12
|
| C. Pelham
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0457
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of a Claim for Generally Recognized as Safe Exemption Based on a Generally Recognized as Safe Determination
|
|
|
|
|
|
|
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS 1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0295
|
| Standard Identity for Pure Birch Syrup and Birch Breakfast Style Syrup
|
| |
|
|
| LET 2
|
| Alaska Birch Syrupmakers Association
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| EMC 2717
|
| C. Lefkowicz
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2718
|
| K. Flores
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2719
|
| K. Marohn
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2720
|
| S. Leatherwood
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2721
|
| E. Lefkowicz
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2722
|
| A. Merz
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2723
|
| K. Hurdle, C.P.T.
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2724
|
| G. Shall
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2725
|
| S. Joseph
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2726
|
| O. Holmes
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2727
|
| B. Royce
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2728
|
| L. Rigg
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2729
|
| K. Cain
|
| Vol #:
|
| 157
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| |
|
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| EMC 2730
|
| K. Reupert
|
| Vol #:
|
| 157
|
| |
|
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| EMC 2731
|
| P. Kays
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2732
|
| K. McCarthy
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2733
|
| M. Berberich
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2734
|
| C. Laspisa
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2735
|
| N. Zodda
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2736
|
| A. Wilmes
|
| Vol #:
|
| 157
|
| |
|
|
| EMC 2737
|
| J. Sweeten
|
| Vol #:
|
| 157
|
| |
|
|
| 2006M-0009
|
| P020001 - STAN S31 Fetal Heart Monitor, Approved 11/1/05
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006M-0014
|
| St. Francis Medical Technologies, Inc, Premarket Approval for X STOP Interspinous Process Decompression System, P040001
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
| 2006M-0015
|
| Biomet Manufacturing Corporation, Premarket Approval of C2a-Taper Acetabular System, P050009
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| |
|
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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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| |
|
|
| 2006M-0075
|
| P020024 - AMPLATZER Duct Occluder and 180 Degree Delivery System, Approved 5/14/03
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| |
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| NAL 1
|
| FDA
|
| Vol #:
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| 1
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|
| |
|
| 2006M-0163
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| H040005 - Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set, Karl Storz Rigid TTTS Fetoscopy Instrument Set with 0 or 12 degree scope, and Karl Storz Rigid TTTS Fetoscopy Instrument Set with 30 degr
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|
|
|
|
|
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| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006N-0237
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
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| |
|
|
| N 1
|
| FDA
|
| Vol #:
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| 1
|
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| |
|
| 2006N-0239
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
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| |
|
|
| N 1
|
| FDA
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| Vol #:
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| 1
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| |
|
|
| 2006O-0232
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
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| |
|
|
| NRD 1
|
| FDA
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| Vol #:
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| 1
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| |
|
|
| 2006P-0265
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| to permit an ANDA Suitability for Cefdinir
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| |
|
|
| ACK 1
|
| FDA/ DDM to Lupin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| |
|
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| CP 1
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| Lupin Pharmaceuticals, Inc.
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| Vol #:
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| 1
|
| |
|
|
| 2006V-0257
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| Laser Light Show
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| |
|
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| CR 1
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| FDA/DDM
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| Vol #:
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| 1
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|
