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| Dockets Entered
August 23, 2006
Table of Contents
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| Docket #
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| Title
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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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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| 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-0345
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
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| 2006M-0340
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| P030016 - Visian ICL (Implantable Collamer Lens)
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| 2006M-0341
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| P050006 - GORE HELEX Septal Occluder
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| 2006M-0342
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| P060004 - MEL 80 Excimer Laser System
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| 2006M-0343
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| P050010 - PRODISC-L Total Disc Replacement
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| 2006N-0292
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| Unique Device Identification
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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-0346
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| Ban Marketing of Estratest, Estratest H.S. and Syntest D.S. and Syntest H.S. associated with Menopause
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| SUP 1
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| Hill Dermaceuticals, Inc.
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| Vol #:
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| 2
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| NPR 1
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| FDA
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| Vol #:
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| 1
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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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| C 18064
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| R. Battle
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| Vol #:
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| 194
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| C 18065
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| A. Waldeck
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| Vol #:
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| 194
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| C 18066
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| A. Esparza
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| Vol #:
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| 194
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| C 18067
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| D. Holmes
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| Vol #:
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| 194
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| EC 33263
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| Mrs. Ellen Cruz
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| Vol #:
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| 142
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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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| C 5
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| Alquest, Inc.
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| Vol #:
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| 1
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| 2006E-0345
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
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| APP 1
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| Astellas Pharma Inc.
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| Vol #:
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| 1
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| APP 2
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| Astellas Pharma 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
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| Vol #:
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| 1
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| LET 2
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| FDA/CDER to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| LET 3
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006M-0340
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| P030016 - Visian ICL (Implantable Collamer Lens)
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| AAV 1
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| STARR Surgical Company
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| Vol #:
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| 1
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| 2006M-0341
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| P050006 - GORE HELEX Septal Occluder
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| AAV 1
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| W. L. Gore & Associates, Inc.
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| Vol #:
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| 1
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| 2006M-0342
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| P060004 - MEL 80 Excimer Laser System
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| AAV 1
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| Carl Zeiss Meditec, Inc.
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| Vol #:
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| 1
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| 2006M-0343
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| P050010 - PRODISC-L Total Disc Replacement
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| AAV 1
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| Synthes Spine Co., L.P.
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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 12
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| Kaweah Delta Health Care District
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| Vol #:
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| 1
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| EC 13
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| St Jude Medical
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| Vol #:
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| 1
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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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| C 7
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| W. Depner
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| Vol #:
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| 4
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| EC 124
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| Mrs. Bonnie Kuhnemann
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| Vol #:
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| 3
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| EC 125
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| Mrs. Jean Gerstner
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| Vol #:
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| 3
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| EC 126
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| Mr. Gary Repair
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| Vol #:
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| 3
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| EC 127
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| Mr. Eric Farr
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| Vol #:
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| 3
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| EC 128
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| Mrs. Rosemary Luther
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| Vol #:
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| 3
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| EC 129
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| Mrs. Marilyn LeFeber
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| Vol #:
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| 3
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| EC 130
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| Mr. Jim Reece
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| Vol #:
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| 3
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| EC 131
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| Mrs. Beth LeGere
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| Vol #:
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| 3
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| EC 132
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| Mrs. Carol Bollig
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| Vol #:
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| 3
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| EC 133
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| Mr. Anthony Felicissimo
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| Vol #:
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| 3
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| 2006P-0346
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| Ban Marketing of Estratest, Estratest H.S. and Syntest D.S. and Syntest H.S. associated with Menopause
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| ACK 1
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| FDA/DDMB to National Women's Health Network
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| Vol #:
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| 1
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| CP 1
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| National Women's Health Network
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| Vol #:
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| 1
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