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| Dockets Entered
On December 27, 2004
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 2000N-0504
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| Egg Safety Action Plan
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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| 2004P-0560
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| ANDA Suitability for Acetaminophen, Butalbital, Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg
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| 2004P-0561
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| ANDA Suitability for Acetaminophen, Butalbital and Caffeine Capsules USP, 300 mg/50 mg/40 mg
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| 2004P-0562
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| Request immediate recall of all unapproved methacholine chiloride products
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| 2004P-0563
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| re-evaluate FDA's policy concening the marketing of "authorized generic" versions of brand name prescription drugs.
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| RPT
1
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| Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
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| Vol #:
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| 127
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| |
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| 2000N-0504
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| Egg Safety Action Plan
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| |
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| EMC 671
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| R. Reichert
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| Vol #:
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| 23
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| EMC 672
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| W. Murphy
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| Vol #:
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| 23
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| EMC 673
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| S. Mahon
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| Vol #:
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| 23
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| EMC 674
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| K. Tassin
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| Vol #:
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| 23
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| EMC 675
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| G. Beatty
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| Vol #:
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| 23
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| EMC 676
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| L. Nealon
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| Vol #:
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| 23
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| |
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| EMC 677
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| M. Hoffman
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| Vol #:
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| 23
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| EMC 678
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| E. Dorfman et al.
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| Vol #:
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| 23
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| |
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| EMC 679
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| B and C Pettit
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| Vol #:
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| 23
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| |
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| EMC 680
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| M. Miller
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| Vol #:
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| 23
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| EMC 681
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| J. Stack
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| Vol #:
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| 23
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| EMC 682
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| S. Ramsey, Esq
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| Vol #:
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| 23
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| EMC 683
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| T. Campbell
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| Vol #:
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| 23
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| EMC 684
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| K. Gillette
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| Vol #:
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| 23
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| EMC 685
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| C. Meyer
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| Vol #:
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| 23
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| EMC 686
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| J. Miller
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| Vol #:
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| 23
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| EMC 687
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| R. Benedict
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| Vol #:
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| 23
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| EMC 688
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| H. Basing
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| Vol #:
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| 23
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| EMC 689
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| J. Wehner
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| Vol #:
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| 23
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| EMC 690
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| T. Martinez
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| Vol #:
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| 23
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| EMC 691
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| J. Riger
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| Vol #:
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| 23
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| EMC 692
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| C. Branson
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| Vol #:
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| 23
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| |
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| EMC 693
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| T. Triplett
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| Vol #:
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| 23
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| |
|
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| EMC 694
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| M. Fata
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| Vol #:
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| 23
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| |
|
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| EMC 695
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| M. Powers
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| Vol #:
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| 23
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| |
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| EMC 696
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| S. Polon
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| Vol #:
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| 23
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| EMC 697
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| B. Silberg
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| Vol #:
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| 23
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| |
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| EMC 698
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| C. Kim
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| Vol #:
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| 23
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| |
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| EMC 699
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| R. Stillman
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| Vol #:
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| 23
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| |
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| EMC 700
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| D. Bell
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| Vol #:
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| 23
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| |
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| EMC 701
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| A. Sandy
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| Vol #:
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| 23
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| |
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| EMC 702
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| M. Jasper
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| Vol #:
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| 23
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| |
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| EMC 703
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| J. Stiener
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| Vol #:
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| 23
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| |
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| EMC 704
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| S. Athanasiou
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| Vol #:
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| 23
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| |
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| EMC 705
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| L. Harvey
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| Vol #:
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| 23
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| |
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| EMC 706
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| T. Grant
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| Vol #:
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| 23
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| |
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| EMC 707
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| D. Durham, ARNP, FNP
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| Vol #:
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| 23
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| |
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| EMC 708
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| Ms. Richards
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| Vol #:
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| 23
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| |
|
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| EMC 709
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| D. Beech
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| Vol #:
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| 23
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| |
|
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| EMC 710
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| D. Beech
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| Vol #:
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| 23
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| |
|
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| EMC 711
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| A. Fassio
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| Vol #:
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| 23
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| |
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| EMC 712
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| K. Walsh
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| Vol #:
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| 23
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| |
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| EMC 713
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| L. Sartori
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| Vol #:
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| 23
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| EMC 714
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| T. Snyder
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| Vol #:
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| 23
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| EMC 715
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| M. Schwartz
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| Vol #:
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| 23
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| EMC 716
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| D. Olsen
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| Vol #:
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| 23
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| |
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| EMC 717
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| N. Hartwig
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| Vol #:
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| 23
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| |
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| EMC 718
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| N. Beavers
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| Vol #:
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| 23
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| |
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| EMC 719
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| L. Joyce
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| Vol #:
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| 23
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| |
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| EMC 720
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| P. Bauer
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| Vol #:
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| 23
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| EMC 721
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| D. Barshay
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| Vol #:
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| 23
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| |
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| EMC 722
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| J. Wilson
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| Vol #:
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| 29
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| |
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| EMC 723
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| L. Fisher
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| Vol #:
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| 23
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| |
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| EMC 724
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| P. Gibson
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| Vol #:
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| 23
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| |
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| EMC 725
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| D. Mazza
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| Vol #:
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| 23
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| |
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| EMC 726
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| Dr A. Rauch
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| Vol #:
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| 23
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| |
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| EMC 727
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| J. Ellis
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| Vol #:
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| 23
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| |
|
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| EMC 728
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| J. Quinn
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| Vol #:
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| 23
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| |
|
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| EMC
729
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| Featherland Egg Farm
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| Vol #:
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| 23
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| |
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| EMC 730
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| C. Insel
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| Vol #:
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| 23
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| |
|
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| EMC 731
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| No signature
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| Vol #:
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| 23
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| |
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| EMC 732
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| No signature
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| Vol #:
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| 23
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|
| | | | | | | |
| |
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| EMC 733
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| L. Weiss
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| Vol #:
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| 23
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| |
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| EMC 734
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| A. Franceschini
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| Vol #:
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| 23
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| |
|
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| EMC 735
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| E. Lewin
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| Vol #:
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| 23
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| |
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| EMC 736
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| W. Helms
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| Vol #:
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| 23
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| |
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| EMC 737
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| No signature
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| Vol #:
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| 23
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| |
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| EMC 738
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| G. Veiby
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| Vol #:
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| 23
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| |
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| EMC 739
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| K. Clark
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| Vol #:
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| 23
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| EMC 740
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| J. Miller
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| Vol #:
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| 23
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| EMC 741
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| R. Peppin, PE
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| Vol #:
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| 23
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| EMC 742
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| A. Hill
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| Vol #:
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| 23
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| |
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| EMC 743
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| E. Archibald, PhD
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| Vol #:
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| 23
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| |
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| EMC 744
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| J. Sugg
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| Vol #:
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| 23
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| |
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| EMC 745
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| A. Black
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| Vol #:
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| 23
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| |
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| EMC 746
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| A. Bruno
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| Vol #:
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| 23
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| |
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| EMC 747
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| L. McRee
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| Vol #:
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| 23
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| |
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| EMC 748
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| M. Raeder
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| Vol #:
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| 23
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| |
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| EMC 749
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| L. Friedberg
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| Vol #:
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| 23
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| |
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| EMC 750
|
| Dan
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| Vol #:
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| 23
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| |
|
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| EMC 751
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| K. Kahn
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| Vol #:
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| 23
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| |
|
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| EMC 752
|
| J. Armer, RN
|
| Vol #:
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| 23
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| |
|
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| EMC 753
|
| M. Woolworth
|
| Vol #:
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| 23
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| |
|
|
| EMC 754
|
| A and B Powers
|
| Vol #:
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| 23
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| |
|
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| EMC 755
|
| J. Denman et al
|
| Vol #:
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| 23
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| |
|
|
| EMC 756
|
| T. Volpe
|
| Vol #:
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| 23
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| |
|
|
| EMC 757
|
| K. Goggio
|
| Vol #:
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| 23
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| |
|
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| EMC 758
|
| D. Holbert
|
| Vol #:
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| 23
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| |
|
|
| EMC 759
|
| G. Farr
|
| Vol #:
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| 23
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| |
|
|
| EMC 760
|
| J. Vias
|
| Vol #:
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| 23
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| |
|
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| EMC 761
|
| C. Borra
|
| Vol #:
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| 23
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| |
|
|
| EMC 762
|
| C. Oschmann
|
| Vol #:
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| 23
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| |
|
|
| EMC 763
|
| E. Jackson
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 764
|
| M. Kang
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 765
|
| N. Dix
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 766
|
| A. Nessel
|
| Vol #:
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| 23
|
| |
|
|
| EMC 767
|
| J. Silliphant
|
| Vol #:
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| 23
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| |
|
|
| EMC 768
|
| C. Smith
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 769
|
| M. Cohen
|
| Vol #:
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| 23
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|
| | | | | | | |
| |
|
|
| EMC 770
|
| B. Schmitz
|
| Vol #:
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| 23
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| |
|
|
| EMC 771
|
| M. Niles
|
| Vol #:
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| 23
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| |
|
|
| EMC 772
|
| L. Rollins
|
| Vol #:
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| 23
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| |
|
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| EMC 773
|
| L. Robinson
|
| Vol #:
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| 23
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| |
|
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| EMC 774
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| E. Angio
|
| Vol #:
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| 23
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| |
|
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| EMC 775
|
| D. Bolbol
|
| Vol #:
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| 23
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| |
|
|
| EMC 776
|
| R. Siegel
|
| Vol #:
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| 23
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| |
|
|
| EMC 777
|
| R. Siegel
|
| Vol #:
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| 23
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| |
|
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| EMC 778
|
| M. Ivy
|
| Vol #:
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| 23
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| |
|
|
| EMC 779
|
| M. Hass
|
| Vol #:
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| 23
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| |
|
|
| EMC 780
|
| P. Larson, DVM, MS, JD
|
| Vol #:
|
| 23
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| |
|
|
| EMC 781
|
| J. Soule, RN
|
| Vol #:
|
| 23
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| |
|
|
| EMC 782
|
| S. Valley
|
| Vol #:
|
| 23
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| |
|
|
| EMC 783
|
| M. Carter et al.
|
| Vol #:
|
| 23
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| |
|
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| EMC 784
|
| E. Andrade
|
| Vol #:
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| 23
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| |
|
|
| EMC 785
|
| B. Short
|
| Vol #:
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| 23
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| |
|
|
| EMC 786
|
| B. Herner
|
| Vol #:
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| 23
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| |
|
|
| EMC 787
|
| E. Dillinger
|
| Vol #:
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| 23
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| |
|
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| EMC 788
|
| J. Wilson
|
| Vol #:
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| 23
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| |
|
|
| EMC 789
|
| D and U Ruben
|
| Vol #:
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| 23
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| |
|
|
| EMC 790
|
| G. Wang
|
| Vol #:
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| 23
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| |
|
|
| EMC 791
|
| K. VanDerzee
|
| Vol #:
|
| 23
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| |
|
|
| EMC 792
|
| Mark
|
| Vol #:
|
| 23
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| |
|
|
| EMC 793
|
| M. Genser
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 794
|
| P. Goodwin
|
| Vol #:
|
| 23
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| |
|
|
| EMC 795
|
| D. Kichler
|
| Vol #:
|
| 23
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| |
|
|
| EMC 796
|
| V. Confectioner
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 797
|
| S. Tullsen
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 798
|
| J. Timmermann
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 799
|
| No signature
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 800
|
| J. Kaszas
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 801
|
| M. Olsen
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 802
|
| L. Bower
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 803
|
| M. Lok
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 804
|
| L. Bower
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 805
|
| G. Wu
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 806
|
| A. DePoalo
|
| Vol #:
|
| 23
|
|
| | | | | | | |
| |
|
|
| EMC 807
|
| S. Dyer
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 808
|
| D. Shapiro, DVM
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 809
|
| Dr. A. Nichols, D.D.
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 810
|
| F. Henry
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 811
|
| C. Shumate
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 812
|
| R. Zeplin
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 813
|
| W. McMullin
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 814
|
| J. Kovich
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 815
|
| K. Cruise
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 816
|
| P. Koteen
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 817
|
| P. Patek
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 818
|
| H. Twining
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 819
|
| S. Schultz
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 820
|
| R. Howard
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 821
|
| L. Slitt
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 822
|
| J. Alexander
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 823
|
| Gwen R.
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 824
|
| P. Marley
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 825
|
| L. Madeleine
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 826
|
| No signature
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 827
|
| J. Norris
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 828
|
| S. Mackenzie
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 829
|
| S. Mackenzie
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 830
|
| J. Shakman
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 831
|
| No signature
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 832
|
| C. Fiacco
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 833
|
| M. Twait
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 834
|
| R.A. Mills
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 835
|
| R. Kalechofsky, PhD
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 836
|
| C. Mizerany
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 837
|
| Dr. J Kohl
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 838
|
| E. Pepich
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 839
|
| J. Buckley
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 840
|
| K. Lok
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 841
|
| R. Freedman
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 842
|
| G. Gardiner
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 843
|
| M. Flower
|
| Vol #:
|
| 23
|
|
| | | | | | | |
| |
|
|
| EMC 844
|
| C. Emerson
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 845
|
| J. Iglesias
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 846
|
| D. Cheng
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 847
|
| N. Orr
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 848
|
| T. Silverman
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 849
|
| M. Rumpsa
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 850
|
| K. Power
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 851
|
| K. Diane
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 852
|
| B and P Gagne
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 853
|
| D. Schweickart
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 854
|
| J. Boehm
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 855
|
| J. Bauman
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 856
|
| L. Terzich
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 857
|
| V. Vrsek
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 858
|
| M. Heinemann
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 859
|
| L. Holing
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 860
|
| C. Babst
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 861
|
| J. Boehm
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 862
|
| T. Wheeler
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 863
|
| A. Sobczyk, Esq
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 864
|
| T. King
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 865
|
| K. Boland
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 866
|
| K. Boland
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 867
|
| B. Domingo, FNP, MS
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 868
|
| B. Nemeroff
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 869
|
| A. Cozza
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 870
|
| N. Myers
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 871
|
| E. Cline
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 872
|
| A. Genis
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 873
|
| K. Zacharias
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 874
|
| L. Riser
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 875
|
| T. Burrell
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 876
|
| B. Wilson
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 877
|
| M. Lyman
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 878
|
| L. Riser
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 879
|
| B. Grimm
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 880
|
| Dr. T. Zausner
|
| Vol #:
|
| 23
|
|
| | | | | | | |
| |
|
|
| EMC 881
|
| M. Scianna
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 882
|
| J. Frey
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 883
|
| J. Taylor
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 884
|
| No signature
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 885
|
| J. Waller
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 886
|
| P. Lritner
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 887
|
| J. Ambur
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 888
|
| C. Kodama
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 889
|
| K. Vayda
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 890
|
| A. Morasca
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 891
|
| R. Walkley
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 892
|
| No signature
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 893
|
| M. Brown
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 894
|
| R. Polvado
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 895
|
| S. Olson
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 896
|
| D. Hancock
|
| Vol #:
|
| 296
|
| |
|
|
| EMC 897
|
| V. Hoppe
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 898
|
| J. Tzucker
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 899
|
| D. Vallero
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 900
|
| N. Gregory
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 901
|
| K. Broussard
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 902
|
| J. Rodriguez
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 903
|
| E. Collins
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 904
|
| T. Rieser
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 905
|
| J. Swann
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 906
|
| No signature
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 907
|
| T. Rieser
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 908
|
| L. Kates
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 909
|
| S. Holcombe
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 910
|
| B. Burke
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 911
|
| J. Johnson
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 912
|
| Dr. J. Thomas
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 913
|
| A. Schweitzer
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 914
|
| L. Fahel
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 915
|
| Dr. J. Thomas
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 916
|
| J. Worl
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 917
|
| L. Nicely
|
| Vol #:
|
| 23
|
|
| | | | | | | | |
| |
|
|
| EMC 918
|
| M. Cascio
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 919
|
| B. Peter
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 920
|
| L. Graber
|
| Vol #:
|
| 23
|
| |
|
|
| EMC 921
|
| K. Piechowki
|
| Vol #:
|
| 23
|
| |
|
|
| 2004D-0524
|
| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
|
| |
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0560
|
| ANDA Suitability for Acetaminophen, Butalbital, Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg
|
| |
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0561
|
| ANDA Suitability for Acetaminophen, Butalbital and Caffeine Capsules USP, 300 mg/50 mg/40 mg
|
| |
|
|
| ACK
1
|
| HFA-350 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0562
|
| Request immediate recall of all unapproved methacholine chiloride products
|
| |
|
|
| ACK
1
|
| HFA-305 to Methapharm Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Tab
1, Tab
2
|
| Methapharm Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0563
|
| re-evaluate FDA's policy concening the marketing of "authorized generic" versions of brand name prescription drugs.
|
| |
|
|
| CP
1
|
| Andrx Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
