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| Dockets Entered
July 17, 2006
Table of Contents
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| Docket #
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| Title
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| 1997V-0470
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| Lazer Light Show
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2002V-0119
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| Laser light show
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| 2002V-0183
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| Laser Light Show
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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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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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004V-0218
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| Laser Light Show
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| 2005P-0146
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| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such 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-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| 2006N-0181
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| Product Stability Data: Notice of Pilot Project
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| 2006N-0266
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| Denial of Request for Change in Classification of Breathing Frequenty Monitor and Electroencephalograph
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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-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| 2006P-0285
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| Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NADA 21-544 for Seasonale
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| 2006V-0164
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| Laser Light Show
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| 1997V-0470
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| Lazer Light Show
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| VRA 4
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| FDA/CDRH to Lazer Onyx
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 673
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| Mission Possible International
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| 10
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| 2002V-0119
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| Laser light show
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| VRA 2
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| FDA/CDRH to George W. Long, Inc./SeaBreeze Amusement
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| Vol #:
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| 1
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| 2002V-0183
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| Laser Light Show
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| VRA 2
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| FDA/CDRH to Funzalosound
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| Vol #:
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| 1
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| OR 16
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| DHHS/ Departmetnal Appeals Board to Korangy Radilogy Associates
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| Vol #:
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| 8
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1323
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| S. Vetter
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| Vol #:
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| 12
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EC 514
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| Mrs. Ira Derrick
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| Vol #:
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| 17
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| 2004V-0218
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| Laser Light Show
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| EXP 1
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| Dreamlight Laser Productions
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| Vol #:
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| 1
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| EC 10
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2005N-0413
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| Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments
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| EMC 7
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| D. Hall
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| Vol #:
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| 2
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| C 42
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| All AMerican Welding Supply, Inc.
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| Vol #:
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| 3
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| 2005P-0146
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| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
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| SUP 1
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| Salix Pharmaceuticals, Inc.
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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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| EC 33250
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| Mrs. Terri Meinhardt
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| Vol #:
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| 142
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| EC 33251
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| Dr. Alfred Mateczun
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| Vol #:
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| 142
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| C 2
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| National Association of Chain Drug Stores (NACDS)
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| Vol #:
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| 1
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| EC 2
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| Talecris Biotherapeutics, Inc.
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| Vol #:
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| 1
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| EC 3
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| Aegate Inc
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| Vol #:
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| 1
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| EC 4
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| PD-Rx Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| EC 5
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| National Association of Chain Drug Stores
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| Vol #:
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| 1
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| EC 6
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| Healthcare Distribution Management Association
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| Vol #:
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| 1
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| EC 7
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| Abbott
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| Vol #:
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| 1
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| EC 8
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| American Pharmacists Association
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| Vol #:
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| 1
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| EC 9
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| McKesson Corporation
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| Vol #:
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| 1
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| 2006N-0181
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| Product Stability Data: Notice of Pilot Project
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| EC 7
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| Monsanto Company
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| Vol #:
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| 1
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| EC 8
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| Apotex Inc
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| Vol #:
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| 1
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| 2006N-0266
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| Denial of Request for Change in Classification of Breathing Frequenty Monitor and Electroencephalograph
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| BKG 1
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| Background Material
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| Vol #:
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| 2
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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 624
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| Ms. Jennifer Yuson
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| Vol #:
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| 3
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| EC 625
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| Ms. Linda Tosti-Lane
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| Vol #:
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| 3
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| EC 626
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| Ms. Mailie La Zarr
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| Vol #:
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| 3
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| EMC 7
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| Form Letter
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| Vol #:
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| 2
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| EC 9
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 10
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 11
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0285
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| Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NADA 21-544 for Seasonale
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| ACK 1
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| FDA/DDM to Duramed Research, Inc.
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| Vol #:
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| 1
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| CP 1
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| Duramed Research, Inc.
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| Vol #:
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| 1
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| 2006V-0164
|
| Laser Light Show
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| VRA 1
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| FDA/CDRH to MGM Productions, Inc.
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| Vol #:
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| 1
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