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| Dockets Entered
On August 21, 2006
Table of Contents
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| Docket #
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| Title
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| 1999N-1852
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| Status reports/postmarketing studies-human drugs&biological
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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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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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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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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| 2006A-0318
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| Request for Advisory Opinion Concerning Orange Book Listing of Patents
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| 2006M-0321
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| P050051 - ARCHITECT AUSAB Reagent Kit, ARCHITECT AUSAB Calibrators, and ARCHITECT AUSAB Controls, Approved 6/1/06
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| 2006M-0322
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| P050011 - Adept (4% Icodextrin) Adhesion Reduction Solution, Approved 7/28/06
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| 2006M-0323
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| P970043/S020 - LADARVision 4000 Excimer Laser System and the LADAR 6000 Excimer Laser System, Approved 5/1/06
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| 2006M-0324
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| P970043/S022 - LADARVision 4000 Excimer Laser System and the LADAR 6000 Excimer Laser System, Approved 5/2/06
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| 2006M-0325
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| P020050/S004 - WaveLight ALLEGRETTO WAVE Excimer Laser System, Approved 7/26/06
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| 2006N-0292
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| Unique Device Identification
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| 2006N-0320
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| Molecular Methods in Immunohematology; Public Workshop
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0186
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| Withdraw new drug application (NDA 21-179) for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| 2006P-0307
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| To amend 21CFR 201.17 regarding expiration dates
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| 2006P-0316
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| Health Claim: Phyposterols and Reduced Risk of Coronary Heart Disease
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| 2006P-0319
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| Regarding review of policies and practices of DDMAC and OCBQ to ensure compliance with first amendment and statutory mandate
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| 2006V-0337
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| Variance for Laser Product "Life Beam Extreme"
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| EC 3
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| Mr. Dave Lowe
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| Vol #:
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| 76
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| 1999N-1852
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| Status reports/postmarketing studies-human drugs&biological
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 648
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| A. Donahue
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| Vol #:
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| 24
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| 2000P-1322
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| Food Labeling and Allergen Contamination Control
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| EMC 3711
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| V. Richiusa
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| Vol #:
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| 195
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| EMC 3712
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| S. Edelman
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| Vol #:
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| 195
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| EMC 3713
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| L. Conti
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| Vol #:
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| 195
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| EMC 3714
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| D. Madison
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| Vol #:
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| 195
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| EMC 3715
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| Dr. K. Coshow
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| Vol #:
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| 195
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| EMC 3716
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| J. Crockwell
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| Vol #:
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| 195
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| EMC 3717
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| D. Bryant
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| Vol #:
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| 195
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| EMC 3718
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| P. Windham
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| Vol #:
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| 195
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| EMC 3719
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| V. SLentz
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| Vol #:
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| 195
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| EMC 3720
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| L. Augenstein
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| Vol #:
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| 195
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| EMC 3721
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| K. Ferguson
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| Vol #:
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| 195
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| EMC 3722
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| L. Kalarness
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| Vol #:
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| 195
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| EMC 3723
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| L. Karm
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| Vol #:
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| 195
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| EMC 3724
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| B. Dash
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| Vol #:
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| 195
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| EMC 3725
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| G. Ellenby
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| Vol #:
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| 195
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| EMC 3726
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| K. Davidson
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| Vol #:
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| 195
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| EMC 3727
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| Dr. G. Golden
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| Vol #:
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| 195
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| EMC 3728
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| R. Gafford
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| Vol #:
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| 195
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| 2006A-0318
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| Request for Advisory Opinion Concerning Orange Book Listing of Patents
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| EC 12
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| Royal Statistical Society
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| Vol #:
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| 1
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| 2006E-0004
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| Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
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| EC 2
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| Mr. David Lowe
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| Vol #:
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| 2
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| 2006M-0321
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| P050051 - ARCHITECT AUSAB Reagent Kit, ARCHITECT AUSAB Calibrators, and ARCHITECT AUSAB Controls, Approved 6/1/06
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| AAV 1
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2006M-0322
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| P050011 - Adept (4% Icodextrin) Adhesion Reduction Solution, Approved 7/28/06
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| AAV 1
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| Innovate PLC
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| Vol #:
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| 1
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| 2006M-0323
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| P970043/S020 - LADARVision 4000 Excimer Laser System and the LADAR 6000 Excimer Laser System, Approved 5/1/06
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| AAV 1
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| Alcon Laboratories, Inc.
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| Vol #:
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| 1
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| 2006M-0324
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| P970043/S022 - LADARVision 4000 Excimer Laser System and the LADAR 6000 Excimer Laser System, Approved 5/2/06
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| AAV 1
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| Alcon Laboratories, Inc.
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| Vol #:
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| 1
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| 2006M-0325
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| P020050/S004 - WaveLight ALLEGRETTO WAVE Excimer Laser System, Approved 7/26/06
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| AAV 1
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| SurgiVision Regulatory Consultants, Inc.
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| EC 7
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| Mr. Adrian Blakey
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| Vol #:
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| 1
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| EC 8
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| Intellareturn Corporation
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| Vol #:
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| 1
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| 2006N-0320
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| Molecular Methods in Immunohematology; Public Workshop
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| EC 712
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| N/A
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| Vol #:
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| 3
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| 2006P-0186
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| Withdraw new drug application (NDA 21-179) for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| EC 66
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| Mrs. Deborah Mitchell
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| Vol #:
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| 3
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| EC 67
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| Mrs. Maxine Journey
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| Vol #:
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| 3
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| EC 68
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| Mr. Randy Vastbinder
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| Vol #:
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| 3
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| EC 69
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| Mrs. Linda Rinderknecht
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| Vol #:
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| 3
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| EC 70
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| Mr. Jim Petersen
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| Vol #:
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| 3
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| EC 71
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| Dr. Michael John Phillips
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| Vol #:
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| 3
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| EC 72
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| Ms. Annette Wright
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| Vol #:
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| 3
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| EC 73
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| Mrs. Marilyn Ingels
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| Vol #:
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| 3
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| EC 74
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| Miss. Kelly Roy
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| Vol #:
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| 3
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| EC 75
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| Mr. Otis Hester
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| Vol #:
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| 3
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| EC 76
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| Mrs. Laura George
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| Vol #:
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| 3
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| EC 77
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| Mr. Charles Craig
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| Vol #:
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| 3
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| EC 78
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| Ms. Marilyn Brien
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| Vol #:
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| 3
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| EC 79
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| Mrs. Robbie Ausley
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| Vol #:
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| 3
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| EC 80
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| Ms. Christina Pagano
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| Vol #:
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| 3
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| EC 81
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| Mrs. Judith Hartig-Osanka
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| Vol #:
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| 3
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| EC 82
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| Miss. Kathy Robbert
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| Vol #:
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| 3
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| EC 83
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| Mr. Craig Timmerman
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| Vol #:
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| 3
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| EC 84
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| Mrs. Alana Wachtel
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| Vol #:
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| 3
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| EC 85
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| Animal Care Center
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| Vol #:
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| 3
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| EC 86
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| Mr. Rod Hellyer
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| Vol #:
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| 3
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| EC 2
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0307
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| To amend 21CFR 201.17 regarding expiration dates
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| |
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| 2006P-0316
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| Health Claim: Phyposterols and Reduced Risk of Coronary Heart Disease
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| ACK 1
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| FDA/CFSAN to Unilever United States, Inc
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| Vol #:
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| 3
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| CP 1
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| Unilever United States, Inc
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| Vol #:
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| 1
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| LET 1
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| FDA/CFSAN to Unilever United States, Inc
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| Vol #:
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| 3
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| SUP 1
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| Unilever United States, Inc
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| Vol #:
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| 3
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| 2006P-0319
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| Regarding review of policies and practices of DDMAC and OCBQ to ensure compliance with first amendment and statutory mandate
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2006V-0337
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| Variance for Laser Product "Life Beam Extreme"
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| ACK 1
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| FDA/ DDM to Blazer Laser Safety, Inc
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| Vol #:
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| 1
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| VAR 1
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| Blazer Laser Safety, Inc
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| Vol #:
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| 1
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