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| Dockets Entered
On August 22, 2006
Table of Contents
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| Docket #
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| Title
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| 1998D-0315
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| Instructions for Submitting Electronic Lot Release Protocols
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002F-0316
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| Safe Use of Mix of Bacteriofages/Antimicrobial Agent
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2004E-0425
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| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
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| 2004E-0427
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| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
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| 2004P-0434
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| ANDA for Additional Dosage of Fluconazole Injetcion, 100mg/50 mL
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| 2005P-0166
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| to prevent the unlawful misbranding of prescription distance glasses and contact lenses
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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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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| 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-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| 2006E-0031
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| Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
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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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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| 2006N-0081
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; 21 CFR Part 203
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| 2006N-0292
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| Unique Device Identification
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| 2006P-0086
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| To declare that the drug product, Butalbital, 50 mg and acetaminophen, 300 mg Tablets, is suitable for consideration in an abbreviated new drug application (ANDA).
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| 2006P-0135
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| Issue Guidance to Industry outlining procedures and standards for initiating an 'expanded access program' for unapproved drugs
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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-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-0273
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| ANDA for Water for Injection, USP, in 3-, 5-, 15-, and 30-mL volumes
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| 2006V-0227
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| Variance for Laser Light Show Projector
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| 1998D-0315
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| Instructions for Submitting Electronic Lot Release Protocols
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| BKG 1
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| Background
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| 1
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7536
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| S. Campbell
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| Vol #:
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| 319
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1390
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| G. Mailley
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| Vol #:
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| 259
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| C 1391
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| R. Dollinger
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| Vol #:
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| 259
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| C 1392
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| D. Menzel
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| Vol #:
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| 259
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| 2002F-0316
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| Safe Use of Mix of Bacteriofages/Antimicrobial Agent
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| NFR 1
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| FDA
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| Vol #:
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| 1
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| EC 30
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| Mr. Dave Lowe
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| Vol #:
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| 5
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| 2004E-0425
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| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
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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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| 2004E-0427
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| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
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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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| 2004P-0434
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| ANDA for Additional Dosage of Fluconazole Injetcion, 100mg/50 mL
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| PAV 1
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| FDA/CDER to Ben Venue Laboratories, Inc.
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| Vol #:
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| 1
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| 2005P-0166
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| to prevent the unlawful misbranding of prescription distance glasses and contact lenses
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| PDN 1
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| FDA/CDRH to International Myopia Prevention Association
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| Vol #:
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| 1
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| SUP 13
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| Department of the Planet Earth
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| Vol #:
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| 5
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| SUP 14
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| Department of the Planet Earth
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| Vol #:
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| 5
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| SUP 15
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| Department of the Planet Earth
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| Vol #:
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| 5
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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 18055
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| B. Larsen
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| Vol #:
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| 194
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| C 18056
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| J. Roberts
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| Vol #:
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| 194
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| C 18057
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| N. VanDeDette
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| Vol #:
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| 194
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| C 18058
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| M. Vincent
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| Vol #:
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| 194
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| C 18059
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| M. Hall
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| Vol #:
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| 194
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| C 18060
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| B. LaScola
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| Vol #:
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| 194
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| C 18061
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| D. Brasmer
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| Vol #:
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| 194
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| C 18062
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| V. Slentz
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| Vol #:
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| 194
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| C 18063
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| B. Earnhardt
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| Vol #:
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| 194
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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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| C 8
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| Precept Food, LLC
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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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| C 3
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| Abbott Laboratories
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| Vol #:
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| 1
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| C 4
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| sanofi-aventis Group
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| Vol #:
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| 1
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| EC 13
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| Blue Cross and Blue Shield Association
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| Vol #:
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| 1
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| EC 14
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| Alquest, Inc.
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| Vol #:
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| 1
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| EC 15
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| University of Minnesota
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| Vol #:
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| 1
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| EC 16
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| CTRAPS
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| Vol #:
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| 1
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| M 1
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| FDA/CBER to DDMB
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| Vol #:
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| 1
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| APP 2
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| Hidenori OHKI et al
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| Vol #:
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| 2
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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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| 2
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| LET 4
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| FDA/CDER to U.S. Patent and Trademark Office
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| Vol #:
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| 2
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| LET 5
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| Patent and Trademark Office
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| Vol #:
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| 2
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| 2006E-0031
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| Patent Extension Application for CLOLAR (clofarabine), U.S. Patent No. 5,661,136
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| LET 4
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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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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| 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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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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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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| 2006N-0081
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; 21 CFR Part 203
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| SS 1
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| Supporting Statement
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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 9
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| Long Beach Memorial Medical Center
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| Vol #:
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| 1
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| EC 10
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| Children's Hospital & Research Center Oakland
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| Vol #:
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| 1
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| EC 11
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| Mr. Brian Vargo
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| Vol #:
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| 1
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| 2006P-0086
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| To declare that the drug product, Butalbital, 50 mg and acetaminophen, 300 mg Tablets, is suitable for consideration in an abbreviated new drug application (ANDA).
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| PAV 1
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| FDA/CDER to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2006P-0135
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| Issue Guidance to Industry outlining procedures and standards for initiating an 'expanded access program' for unapproved drugs
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| C 2
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| Alliance for Childhood Cancer
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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 713
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| none
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| Vol #:
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| 3
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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 5
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| F. Smith, MD
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| Vol #:
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| 4
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| C 6
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| T. Schrempp
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| Vol #:
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| 4
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| EC 109
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| Mr. Jordan Waterhouse
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| Vol #:
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| 3
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| EC 110
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| Mrs. Joan Cole
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| Vol #:
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| 3
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| EC 111
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| self
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| Vol #:
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| 3
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| EC 112
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| Republican Majority for Choice
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| Vol #:
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| 3
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| EC 113
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| Mrs. Janet Aleo
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| Vol #:
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| 3
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| EC 114
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| Mrs. sharon Kangas
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| Vol #:
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| 3
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| EC 115
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| Mrs. carrie paraiso
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| Vol #:
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| 3
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| EC 116
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| Mr. Jules Dubuisson
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| Vol #:
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| 3
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| EC 117
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| Mr. Robert Graves
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| Vol #:
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| 3
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| EC 118
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| Mrs. c whelan
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| Vol #:
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| 3
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| EC 119
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| Family Man
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| Vol #:
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| 3
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| EC 120
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| Mrs. Judith Imes
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| Vol #:
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| 3
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| EC 121
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| Mrs. Linda Webster
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| Vol #:
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| 3
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| EC 122
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| Mrs. Zelma Gragg
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| Vol #:
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| 3
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| EC 123
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| Oklahoma Religious Coalition for Rproductive Choic
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| Vol #:
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| 3
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| 2006P-0273
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| ANDA for Water for Injection, USP, in 3-, 5-, 15-, and 30-mL volumes
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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-0227
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| Variance for Laser Light Show Projector
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| VRA 1
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| FDA/CDRH to Kiamesha Lanes
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| Vol #:
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| 1
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