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| Dockets Entered
On April 26, 2007
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1983V-0151
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| LASER LIGHT SHOW
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 2000P-1602
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| Remove Unapproved Children's Fluoride Supplements from Mkt
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| 2003D-0044
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| Reporting Results for Studies Evaluating Diagnostic Tests
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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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-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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| 2006P-0428
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| Combivent (ipratropium bromide and albuterol sulfate)
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| 2006P-0442
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
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| 2006P-0445
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| Determine if Mivacron (mivacurium chloride injection) was withdrawn for safety or efficacy reasons
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| 2006P-0446
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| ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
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| 2006P-0450
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| Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
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| 2007A-0164
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| Request for Advisory Opinion for an Mobilecare Monitor System 2100
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| 2007N-0051
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| Safety of Fresh Produce; Public Hearings
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| 1978N-0038
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| Sunscreen Drug Products
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| C 613
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| Premiere Center for Cosmetic Surgery
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| Vol #:
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| 150
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| C 614
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| Hillsborough County Florida
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| Vol #:
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| 150
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| C 615
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| State of New York, Albany
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| Vol #:
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| 150
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| 1983V-0151
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| LASER LIGHT SHOW
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| VRA 11
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| FDA/CDRH to Precision Projection Systems, Inc
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| Vol #:
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| 1
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP 51
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| Immediate Trial, INC 70376, Milwaukee, Wisconsin
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| Vol #:
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| 56
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 376
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| Louis Montgomery Enterprises
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| Vol #:
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| 297
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| 2000P-1602
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| Remove Unapproved Children's Fluoride Supplements from Mkt
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| LET 3
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| FDA/CDER to J Kelly
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| Vol #:
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| 1
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| LET 4
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| FDA/CDER to J Kelly
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| Vol #:
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| 1
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| 2003D-0044
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| Reporting Results for Studies Evaluating Diagnostic Tests
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| EC 5
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| DHL
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| Vol #:
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| 1
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| C 15
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| J. Resnick
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| Vol #:
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| 1
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| C 16
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| M. & G. Krieger
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| C 721
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| Food Marketing Institute
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| Vol #:
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| 35
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| C 722
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| U. S. A. Rice Federation
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| Vol #:
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| 35
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| C 723
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| Food Products Association
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| Vol #:
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| 35
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| C 724
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| L. Block
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| Vol #:
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| 35
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| C 725
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| Glutino U. S. A.
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| Vol #:
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| 35
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| C 726
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| International Wheat Gluten Association
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| Vol #:
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| 35
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| C 727
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| International Wheat Gluten Association
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| Vol #:
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| 35
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| C 728
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| Coastal Counseling Clinic
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| Vol #:
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| 35
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| C 729
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| The Vinegar Institute
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| Vol #:
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| 35
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| C 730
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| Association des Amldenniers et Foculiers
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| Vol #:
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| 35
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| C 731
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| Celiac Sprue Association U. S. A., Inc.
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| Vol #:
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| 35
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| C 732
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| T. Sullivan
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| Vol #:
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| 35
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| C 733
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| S. Tolley
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| Vol #:
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| 35
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| C 734
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| China SPS Enquiry Point, AQSIQ
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| Vol #:
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| 35
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| C 735
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| F. Tibbits
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| Vol #:
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| 35
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| C 736
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| C. Adams
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| Vol #:
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| 35
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| C 737
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| International Wheat Gluten Association
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| Vol #:
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| 35
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| EC 1962
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| Mrs. Nadine Marx
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| Vol #:
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| 31
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| EC 1963
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| Mrs. Laurie Anderson
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| Vol #:
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| 31
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| EC 1964
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| Ms. Amber Brenzikofer
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| Vol #:
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| 31
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| EC 1965
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| Ms. Huberta Yaron
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| Vol #:
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| 31
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| EC 1966
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| Ms. Jerilyn Ingram
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| Vol #:
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| 31
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| EC 1967
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| Mrs. PATRICIA KACZMAREK
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| Vol #:
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| 31
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| EC 1968
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| Dr. Joan Chase
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| Vol #:
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| 31
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| EC 1969
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| Healthy Villi-CSA/USA
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| Vol #:
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| 31
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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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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| C 87
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| G. Schumacher
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| Vol #:
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| 7
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| C 88
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| Little Art Theatre
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| Vol #:
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| 7
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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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| C 2
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| Minnesota House of Representatives
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| Vol #:
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| 2
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| 2006P-0428
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| Combivent (ipratropium bromide and albuterol sulfate)
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| LET 1
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| FDA/CDER to Boehringer Ingelheim Pharmaceuticalws Inc
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| Vol #:
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| 2
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| 2006P-0442
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
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| LET 1
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| FDA/CDER to Orchid Healthcare
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| Vol #:
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| 1
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| 2006P-0445
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| Determine if Mivacron (mivacurium chloride injection) was withdrawn for safety or efficacy reasons
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| LET 1
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| FDA/CDER to Regulus Pharmaceutical Consulting Inc
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| Vol #:
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| 1
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| 2006P-0446
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| ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
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| LET 1
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| FDA/Taro Pharmaceuticals USA Inc
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| Vol #:
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| 1
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| 2006P-0450
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| Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
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| LET 1
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| FDA/CDER to Pfizer Inc
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| Vol #:
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| 2
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| 2007A-0164
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| Request for Advisory Opinion for an Mobilecare Monitor System 2100
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| ACK 1
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| FDA/DDM to AFrame Digital, Inc
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| Vol #:
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| 1
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| AP 1
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| AFrame Digital, Inc
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| Vol #:
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| 1
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| 2007N-0051
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| Safety of Fresh Produce; Public Hearings
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| C 7
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| L-3 Pulse Sciences
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| Vol #:
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| 1
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| C 8
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| Path Trace
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| Vol #:
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| 1
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| TS 1
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| Centers for Disease Control and Prevention
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| Vol #:
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| 1
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| TS 2
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| Cemter for Food Safety and Applied Nutrition
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| Vol #:
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| 1
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| TS 3
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| University of California, Davis
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| Vol #:
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| 1
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| TS 4
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| FDA/ Center for Food Sfaety and Applied Nutrition
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| Vol #:
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| 1
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| TS 5
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| FDA/ Office of Regulatory Affairs
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| Vol #:
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| 1
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 109
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| Evelyn, Brenda
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| Vol #:
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| 1
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| C 1
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| C. Weber
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| Vol #:
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| 1
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