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| Dockets Entered
On April 19, 2007
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| Docket #
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| Title
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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-0107
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| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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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-0387
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| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
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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-0428
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| Combivent (ipratropium bromide and albuterol sulfate)
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| 2007D-0040
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| Guidance for Industry on Developing Products for Weight Management
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| 2007M-0151
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| P05048 - MONOLISA Anti-HBs EIA and MONOLISA Anti-HBs Calibrator Kit
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| 2007M-0152
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| P060007 - ARCHITECT HBsAg Reagent Kit, ARCHITECT HBsAg Calibrators, ARCHITECT HBsAg Controls, ARCHITECT HBsAg Confirmatory Reagent Kit,
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| 2007N-0077
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| Withdrawal of Approval of New Animal Drug Applications; Pyrantel; Tylosin; Tylosin and Sulfamethazine
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| 2007N-0078
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| Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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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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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| C 14
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| C. Feder
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| Vol #:
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| 1
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| EC 47
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| Mrs. MaryAnnl Langford
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| Vol #:
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| 6
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| EC 48
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| Mr. Michael Schwaba
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| Vol #:
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| 6
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| EC 49
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| Mr. jeffrey karcz
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| Vol #:
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| 6
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| EC 50
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| Mrs. Laura Fine
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| Vol #:
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| 6
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| EC 51
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| Mrs. Jo Alice Stultz
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| Vol #:
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| 6
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| EC 52
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| Ms. Laurie Hoppe
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| Vol #:
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| 6
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| EC 53
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| Humans
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| Vol #:
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| 6
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| EC 54
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| Mrs. Carole Laurencelle
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| Vol #:
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| 6
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| EC 55
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| Mrs. Jocelyne Taylot
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| Vol #:
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| 6
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| EC 56
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| Ms. Marge Bonaker
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| Vol #:
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| 6
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| EC 57
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| Mr. Scott Dubois
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| Vol #:
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| 6
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| EC 58
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| Mrs. Julianne Stevenson
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| Vol #:
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| 6
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| EC 59
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| Ms. Cheryl Jones
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| Vol #:
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| 6
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| EC 60
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| Mr. Stephen Wright
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| Vol #:
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| 6
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| EC 61
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| Mr. Brian Venable
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| Vol #:
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| 6
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| EC 62
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| Mrs. Renee Irvin-Tracy
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| Vol #:
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| 6
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| EC 63
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| Ms. Mary Jane levell
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| Vol #:
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| 6
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| EC 64
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| Levell Argentine Exterior Desigh and Landscape
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| Vol #:
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| 6
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| EC 65
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| Miss. Stacia Gondusky
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| Vol #:
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| 6
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| EC 66
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| Mrs. mary fowler
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| Vol #:
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| 6
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| EC 67
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| Mrs. Ann Bullock
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| Vol #:
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| 6
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| EC 68
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| Ms. Debra Cook
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| Vol #:
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| 6
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| EC 69
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| Ms. Sue Laycock
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| Vol #:
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| 6
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| EC 70
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| Ms. Diane Schrum
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| Vol #:
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| 6
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| EC 71
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| Mr. Maurice Mandel
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| Vol #:
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| 6
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| EC 72
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| Ms. Janice Castle
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| Vol #:
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| 6
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| EC 73
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| Ms. Kathy Van Dame
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| Vol #:
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| 6
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| EC 74
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| Mr. David Anderson
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| Vol #:
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| 6
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| EC 75
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| Mr. Daniel Rivers
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| Vol #:
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| 6
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| EC 76
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| Ms. Karen Steward
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| Vol #:
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| 6
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| EC 77
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| Mr. James Wembley
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| Vol #:
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| 6
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| EC 78
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| Mr. Stanley Naftaly
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| Vol #:
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| 6
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| EC 79
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| Ms. Diane Macaluso
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| Vol #:
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| 6
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| EC 80
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| Mr. Tim Jeffries
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| Vol #:
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| 6
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| EC 81
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| Mr. Paul Weber
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| Vol #:
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| 6
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| EC 82
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| Ms. Heather Urwiller
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| Vol #:
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| 6
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| EC 83
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| Dr. Charles Morris
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| Vol #:
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| 6
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| EC 84
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| n/a
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| Vol #:
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| 6
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| EC 85
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| Mr. Andrew Garfunkel
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| Vol #:
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| 6
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| EC 86
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| Mrs. Hazel Zamperini
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| Vol #:
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| 6
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| EC 87
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| Ms. Mary Stein
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| Vol #:
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| 6
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| EC 88
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| Ms. amy pickering
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| Vol #:
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| 6
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| EC 89
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| Miss. cordelia elias
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| Vol #:
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| 6
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| EC 90
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| Mrs. Erin Kopacz
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| Vol #:
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| 6
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| EC 91
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| Ms. lavonne ford
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| Vol #:
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| 6
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| EC 92
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| Mrs. Jackie Hall
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| Vol #:
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| 6
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| EC 93
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| Mr. David Lewis
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| Vol #:
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| 6
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| EC 94
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| Dr. Denette King
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| Vol #:
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| 6
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| EC 95
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| Ms. Linda Neiswender
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| Vol #:
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| 6
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| EC 96
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| Ms. Stephanie Neumann
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| Vol #:
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| 6
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| EC 97
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| Mr. Gregory Gershkovich
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| Vol #:
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| 6
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| EC 98
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| Mark Doyle Farm Services
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| Vol #:
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| 6
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| EC 99
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| Grandmother
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| Vol #:
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| 6
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| EC 100
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| Mrs. Amanda Lawless
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| Vol #:
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| 6
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| EC 101
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| Miss. Ann Keisler
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| Vol #:
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| 6
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| EC 102
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| Mr. Neil Levin
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| Vol #:
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| 6
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| EC 103
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| Ms. Debrah Roemisch
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| Vol #:
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| 6
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| EC 104
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| FoodConsumer.org
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| Vol #:
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| 6
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| EC 105
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| Ms. Stacey Kerr
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| Vol #:
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| 6
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| EC 106
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| Ms. Candace Shade
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| Vol #:
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| 6
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| EC 107
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| Center for Self Awareness & Empowerment
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| Vol #:
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| 6
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| EC 108
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| Ms. Thrisa Walters
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| Vol #:
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| 6
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| EC 109
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| Ms. Susan Haberern
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| Vol #:
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| 6
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| EC 110
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| DS Gaus Corporation
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| Vol #:
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| 6
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| EC 111
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| Ms. Bonnie Walden
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| Vol #:
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| 6
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| EC 112
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| Mrs. Debbie Ullman
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| Vol #:
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| 6
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| EC 113
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| Ms. Lavina Wetterberg
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| Vol #:
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| 6
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| EC 114
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| Ms. Heather Kile
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| Vol #:
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| 6
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| EC 115
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| Mr. Philip Ratcliff
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| Vol #:
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| 6
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| EC 116
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| Mr. Larry Burg
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| Vol #:
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| 6
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| EC 117
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| Mrs. Shelli Black
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| Vol #:
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| 6
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| EC 118
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| Ms. K. O'Brien
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| Vol #:
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| 6
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| EC 119
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| Mrs. Linda Greene
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| Vol #:
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| 6
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| EC 120
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| Mr. Eugene Spinadel
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| Vol #:
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| 6
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| EC 121
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| Ms. Carol Robinson
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| Vol #:
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| 6
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| EC 122
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| Mrs. Cheryl Bauer
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| Vol #:
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| 6
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| EC 123
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| Ms. Sara Robinson
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| Vol #:
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| 6
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| EC 124
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| Mr. Russel Robinson
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| Vol #:
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| 6
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| EC 125
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| Miss. Kiersten Robinson
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| Vol #:
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| 6
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| EC 126
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| Mr. paul callicoat
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| Vol #:
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| 6
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| EC 127
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| Mr. James Simmons
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| Vol #:
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| 6
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| EC 128
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| Mr. Mark Bryant
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| Vol #:
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| 6
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| EC 129
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| Mr. PATRICK AVENDT
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| Vol #:
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| 6
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| EC 130
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| Alberts Organics
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| Vol #:
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| 6
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| EC 131
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| Mrs. cindy krueger
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| Vol #:
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| 6
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| EC 132
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| Mr. FRANK JAEGER
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| Vol #:
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| 6
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| EC 133
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| Ms. C Balint
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| Vol #:
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| 6
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| EC 134
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| Mrs. Heidi Harrigan
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| Vol #:
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| 6
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| C 720
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| C. Huskisson
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| Vol #:
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| 32
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| |
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| EC 1888
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| Mr. Stan McCullars
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| Vol #:
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| 31
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| EC 1889
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| Ms. Tania Larson
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| Vol #:
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| 31
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| EC 1890
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| Ms. Barbara Korman
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| Vol #:
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| 31
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| EC 1891
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| Mrs. Diane Eblin
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| Vol #:
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| 31
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| EC 1892
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| Mrs. Lori Norman
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| Vol #:
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| 31
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| EC 1893
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| Mr. Robert Fireovid
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| Vol #:
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| 31
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| EC 1894
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| Mr. Robert Fireovid
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| Vol #:
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| 31
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| EC 1895
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| Ms. Cecilia Fabrizio
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| Vol #:
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| 31
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| EC 1896
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| Cold Spring Harbor Laboratory
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| Vol #:
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| 31
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| EC 1897
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| Mrs. Diane Blankenship
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| Vol #:
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| 31
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| EC 1898
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| Mr. Michael Tetlow
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| Vol #:
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| 31
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| EC 1899
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| Ms. Donna Batten
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| Vol #:
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| 31
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| EC 1900
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| Canadian Celiac Association
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| Vol #:
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| 31
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| |
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| EC 1901
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| Healthy Fusion, LLC
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| Vol #:
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| 31
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| EC 1902
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| Bob's Red Mill Natural Foods, Inc.
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| Vol #:
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| 31
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| EC 1903
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| Ms. Caroline Miles
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| Vol #:
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| 31
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| EC 1904
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| Mrs. Maria Elena Martinez
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| Vol #:
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| 31
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| EC 1905
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| Universidad Central del Caribe SOM
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| Vol #:
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| 31
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| EC 1906
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| Nurse Practitioner
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| Vol #:
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| 31
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| EC 1907
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| Ms. Moira Harding
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| Vol #:
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| 31
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| EC 1908
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| SMAP Celiacs de Catalunya
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| Vol #:
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| 31
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| EC 1909
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| Mr. David Givers
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| Vol #:
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| 31
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| |
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| 2005P-0107
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| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
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| |
|
|
| C 2
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| Duke University Medical Center-Duke Clinical Research Institute
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| Vol #:
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| 1
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| |
|
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| |
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| C 18
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| Smith & Nephew
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| Vol #:
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| 7
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| |
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| C 19
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| Bone Growth Stimulator (BGS)
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| Vol #:
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| 7
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| |
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| 2006D-0480
|
| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| |
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| C 32
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| Form Letter Count 2
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| Vol #:
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| 3
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| C 33
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| Form Letter Count 3
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| Vol #:
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| 4
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| C 34
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| Form Letter Count 5
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| Vol #:
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| 5
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| |
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| C 35
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| Anti-Aging Clinic Association, Inc.
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| Vol #:
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| 2
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| C 36
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| Anti-Aging Clinic Association, Inc.
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| Vol #:
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| 2
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| C 37
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| G. Bedding
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| Vol #:
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| 2
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| C 38
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| C. Longacre
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| Vol #:
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| 2
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| C 39
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| N. Perigo
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| Vol #:
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| 2
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| |
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| C 40
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| D. Ferguson
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| Vol #:
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| 2
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| |
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| C 41
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| F. Padilla
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| Vol #:
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| 2
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| |
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| C 42
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| R. Kostreba
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| Vol #:
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| 2
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| |
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| C 43
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| R. Huff
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| Vol #:
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| 2
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| |
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| C 44
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| R. Leal
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| Vol #:
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| 2
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| |
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| C 45
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| C. Leal
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| Vol #:
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| 2
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| |
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| C 46
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| J. Occhiogrosso
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| Vol #:
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| 2
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| |
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| C 47
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| G. Darrigon
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| Vol #:
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| 2
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| |
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| C 48
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| R. Smith
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| Vol #:
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| 2
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| |
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| C 49
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| T. Randall
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| Vol #:
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| 2
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| |
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| C 50
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| S. Worthen
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| Vol #:
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| 2
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| |
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| C 51
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| J. Randall
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| Vol #:
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| 2
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| |
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| C 52
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| S. Hotchkiss
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| Vol #:
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| 2
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| |
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| C 53
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| K. Conrad
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| Vol #:
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| 2
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| |
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| C 54
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| E. Buenaventura
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| Vol #:
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| 2
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| |
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| C 55
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| T. & J. Martin
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| Vol #:
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| 2
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| |
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|
| LET 1
|
| American Herbal Products Association
|
| Vol #:
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| 2
|
| |
|
|
| 2006P-0387
|
| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
|
| |
|
|
| C 1
|
| Stiefel Laboratories, Inc.
|
| Vol #:
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| 1
|
|
| |
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
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| |
|
|
| C 84
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| K. Montiel
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| Vol #:
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| 7
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| |
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| C 85
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| E. Smith
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| Vol #:
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| 7
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| |
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| C 86
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| A. Villalobos
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| Vol #:
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| 7
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| |
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| EC 1143
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| Mrs. Pauline Rosa-Martir Schepper
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| Vol #:
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| 9
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| |
|
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| EC 1144
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| None
|
| Vol #:
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| 9
|
| |
|
|
| 2006P-0428
|
| Combivent (ipratropium bromide and albuterol sulfate)
|
| |
|
|
| C 3
|
| The National Emphysema Foundation
|
| Vol #:
|
| 2
|
| |
|
|
| 2007D-0040
|
| Guidance for Industry on Developing Products for Weight Management
|
| |
|
|
| C 5
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
| |
|
|
| C 6
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
|
| |
|
| 2007M-0151
|
| P05048 - MONOLISA Anti-HBs EIA and MONOLISA Anti-HBs Calibrator Kit
|
| |
|
|
| AAV 1
|
| Bio-Rad Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0152
|
| P060007 - ARCHITECT HBsAg Reagent Kit, ARCHITECT HBsAg Calibrators, ARCHITECT HBsAg Controls, ARCHITECT HBsAg Confirmatory Reagent Kit,
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| | | | | | | | |
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| |
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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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| |
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| 2007N-0077
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| Withdrawal of Approval of New Animal Drug Applications; Pyrantel; Tylosin; Tylosin and Sulfamethazine
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| |
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 2007N-0078
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| Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate
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| |
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| |
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| EAPE 72
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| Gelsinger, Timothy
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| Vol #:
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| 1
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| |
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| EAPE 73
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| Fahey, Mike
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| Vol #:
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| 1
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| |
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| EAPE 74
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| Vermette, Mark
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| Vol #:
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| 1
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| |
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| EAPE 75
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| Thayne, Anne
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| Vol #:
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| 1
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| |
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| EAPE 76
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| Bland, James
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| Vol #:
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| 1
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| |
|
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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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| |
|
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| EAPE 87
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| Thurber, Steven
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| Vol #:
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| 1
|
| |
|
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| EAPE 88
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| Vadiei, Kiumars
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| Vol #:
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| 1
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| |
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| EAPE 89
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| Ehrlich, Diane
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| Vol #:
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| 1
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| |
|
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| EAPE 90
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| Carter, Linda
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| Vol #:
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| 1
|
| |
|
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| EAPE 91
|
| Jett, Sara
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| Vol #:
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| 1
|
| |
|
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| EAPE 92
|
| Melville, Scott
|
| Vol #:
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| 1
|
| |
|
|
| EAPE 93
|
| Freitas, Kristen
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| Vol #:
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| 1
|
| |
|
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| EAPE 94
|
| Fri, Perry
|
| Vol #:
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| 1
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| |
|
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| EAPE 95
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| Cherico, Brian
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| Vol #:
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| 1
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| |
|
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| EAPE 96
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| DePuy, Marjorie
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| Vol #:
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| 1
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