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| Dockets Entered
On March 14, 2007
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| Docket #
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| Title
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| 1994D-0025
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| Interim GDL/Labeling Milk & Milk Products from Cows w/rbST
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| 1997E-0013
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| Reteplase; Patent Term Extension Application No. 5,223,256
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004P-0464
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| Vitamin D & Calcium & Reduced Risk of Osteoporosis
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006E-0240
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| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
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| 2006E-0354
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| Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver
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| 2006N-0238
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| Debarment of Maria Anne Kirkman Campbell
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| 2007M-0084
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| P050053 - InFuse Bone Graft
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| 2007M-0086
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| P050013 - Histoacryl and Histoacryl Blue Topical Skin Adhesive
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| 2007N-0026
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| Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
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| 2007P-0094
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| Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the- counter
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| 2007V-0095
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| Laser Light Show
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| 1994D-0025
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| Interim GDL/Labeling Milk & Milk Products from Cows w/rbST
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| C 8585
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| Form Letter Count 421
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| Vol #:
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| 118
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| C 8586
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| D. Brandt
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| Vol #:
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| 116
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| C 8587
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| T. Krall
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| Vol #:
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| 116
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| C 8588
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| Monsanto imagine
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| Vol #:
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| 116
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| 1997E-0013
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| Reteplase; Patent Term Extension Application No. 5,223,256
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 19427
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19428
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19429
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| JOL Management
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| Vol #:
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| 173
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| LET 19430
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| Pharmanex, LLC
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| Vol #:
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| 173
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| LET 19431
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| Metagenics, Inc.
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| Vol #:
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| 173
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| LET 19432
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| Window Rock Enterprises, Inc.
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| Vol #:
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| 173
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| LET 19433
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| FoodScience Corporation
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| Vol #:
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| 173
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| LET 19434
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19435
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19436
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19437
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19438
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19439
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19440
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19441
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19442
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19443
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19444
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19445
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19446
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19447
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19448
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19449
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19450
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 173
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| LET 19451
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| FoodScience Corporation
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| Vol #:
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| 173
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| LET 19452
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| Tabak's Health Products
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| Vol #:
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| 173
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| LET 19453
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19454
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19455
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19456
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19457
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19458
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19459
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19460
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| NewMark: A Division of New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19461
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19462
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19463
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19464
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19465
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19466
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19467
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| New Chapter, Inc.
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| Vol #:
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| 173
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| LET 19468
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| InterHealth Neutraceuticals, Inc.
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| Vol #:
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| 173
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 42
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| Ms. Denise Glass
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| Vol #:
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| 8
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| EC 43
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| Mr. Roger Huckfeldt
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| Vol #:
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| 8
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| TR 4
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| Transciprt of the September 12, 2006 Meeting
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| Vol #:
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| 8
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| TS 18
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| FDA - Challenges in Developing a Risk Ranking Model for Feed Contaminants
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| Vol #:
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| 8
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| TS 19
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| FDA - Welcome
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| Vol #:
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| 8
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| TS 20
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| FDA - Risk, Risk Ranking and the AFSS: Where are we going?
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| Vol #:
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| 8
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| TS 21
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| FDA - List of Potentially Hazardous Contaminants in Animal Fee and Feed Ingredients
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| Vol #:
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| 8
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| TS 22
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| FDA - Health Consequence Scoring for Biological Contaminants in Animal Feed
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| Vol #:
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| 8
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| TS 23
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| FDA - Health Consequence Scoring for Chemical Contaminants in Animal Feed
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| Vol #:
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| 8
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| 2004P-0464
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| Vitamin D & Calcium & Reduced Risk of Osteoporosis
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| C 1
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| Juice Products Association
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| Vol #:
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| 9
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| C 2
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| Shaklee Corporation
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| Vol #:
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| 9
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| EC 13
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| Physicians Committee for Responsible
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| Vol #:
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| 9
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| EC 14
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| Society for Nutrition Education
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| Vol #:
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| 9
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| C 549
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| Form Letter Count 2
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| Vol #:
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| 40
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| C 550
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| Form Letter Count 3
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| Vol #:
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| 41
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| C 551
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| B. Adams
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| Vol #:
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| 42
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| C 552
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| A. Bullyan
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| Vol #:
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| 42
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| C 553
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| number not used
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| Vol #:
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| 42
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| C 13
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| American Association for Clinical Chemistry (AACC)
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| Vol #:
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| 1
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| C 14
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| Save Babies Through Screening
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| Vol #:
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| 1
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| 2006E-0240
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| Patent Extension Application for REVLIMID (lenalidomide), U.S. Patent No. 5,635,517
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| |
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0354
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| Patent Extension Application for VAPRISOL (conivaptan hydrochloride), U.S. Patent No. 5,723,606
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2006N-0238
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| Debarment of Maria Anne Kirkman Campbell
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| LET 1
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| FDA/CDER to Maria Anne Krkman Campbell
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| Vol #:
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| 1
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| 2006N-0525
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| Supplements and Other Changes to an Approved Application
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| C 3
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| Consumer Healthcare Products Association (CHPA)
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| Vol #:
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| 1
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| C 4
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| Schering-Plough
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| Vol #:
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| 1
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| EC 6
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| Genentech, Inc.
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| Vol #:
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| 1
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| EC 7
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| Combination Products Coalition
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| Vol #:
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| 1
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| EC 8
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| Novo Nordisk Inc.
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| Vol #:
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| 1
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| EC 9
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| AstraZeneca LP
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| Vol #:
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| 1
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| EC 10
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| Amgen
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| Vol #:
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| 1
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| EC 11
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| Novartis Pharmaceuticals Corporation
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| Vol #:
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| 1
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| EC 12
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| Pfizer Inc
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| Vol #:
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| 1
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| 2007M-0084
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| P050053 - InFuse Bone Graft
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| AAV 1
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| Medtronic Sofamor Danek USA, Inc.
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| Vol #:
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| 1
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| 2007M-0086
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| P050013 - Histoacryl and Histoacryl Blue Topical Skin Adhesive
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| AAV 1
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| Kamm and Associates
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| Vol #:
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| 1
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| 2007N-0026
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| Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
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| BKG 1
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| Background Information
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| Vol #:
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| 1
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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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| 2007P-0094
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| Switch Allegra (Fexofendaine Hydrochloride), and Zyrtec (Cetirzine Hydrochloride) and Zyrtec D (Cetirizine Hydrochloride; Pseudophedrine Hydrochloride) from prescription drugs to over-the-counter
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| ACK 1
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| FDA/DDM to Greenberg Traurig LLP
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| Vol #:
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| 1
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| CP 1
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| Greenberg Traurig LLP
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| Vol #:
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| 1
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| 2007V-0095
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| Laser Light Show
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| ACK 1
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| FDA /DDM to Lasersmith Light Show Systems, LLC
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| Vol #:
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| 1
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| VAR 1
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| Lasersmith Light Show Systems, LLC
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| Vol #:
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| 1
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