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| Dockets Entered
On March 8, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 1998D-1146
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| Microbial effects of antimicrobial new animal drugs/human sa
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| |
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| |
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| 1998P-1121
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| Grated Parmesan Cheese Deviating from Identity standard
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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| 2002N-0275
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| Bioterrorism Preparedness; Administrative Detention
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| |
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| 2003D-0111
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| Potassium Iodide Tablets Shelf Life Extension
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| 2003D-0204
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| Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations; Availability
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| |
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| 2003D-0493
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| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
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| 2003N-0338
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| Obesity
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| |
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003P-0266
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| Lovenos(enoxaparin sodlium),NDA 20-164(90mg/0.6ml(product number 006),was not withdrawn from sale for reasons of safety or effectiveness sponsored by Aventis Pharmaceuticalls inc.
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003Q-0559
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| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
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| |
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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|
|
| RPT
17
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| Northfield Laboratories, Inc.
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| Vol #:
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| 24
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|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13010
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| LET
13011
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| LET
13012
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| LET
13013
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| LET
13014
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| |
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| LET
13015
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| Natures Benefit, Inc,.
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| Vol #:
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| 106
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| LET
13016
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| |
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| LET
13017
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| LET
13018
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| |
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| LET
13019
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| Natures Benefit, Inc.
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| Vol #:
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| 106
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| LET
13020
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| NBTY Inc.
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| Vol #:
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| 106
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| LET
13021
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| NBTY Inc.
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| Vol #:
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| 106
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| LET
13022
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| NBTY Inc.
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| Vol #:
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| 106
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| |
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| LET
13023
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| NBTY Inc.
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| Vol #:
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| 106
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| |
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| LET
13024
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| NBTY Inc.
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| Vol #:
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| 106
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| |
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| LET
13062
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| NBTY Inc.
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| Vol #:
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| 106
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| |
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| LET
13063
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| NBTY Inc.
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| Vol #:
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| 106
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| LET
13064
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| NBTY Inc.
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| Vol #:
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| 106
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| LET
13065
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| NBTY Inc.
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| Vol #:
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| 106
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| |
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| LET
13066
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| NBTY Inc.
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| Vol #:
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| 106
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| LET
13067
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| NBTY Inc.
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| Vol #:
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| 106
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| |
|
|
| 1998D-1146
|
| Microbial effects of antimicrobial new animal drugs/human sa
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| C 105
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| D. McCubbin
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| Vol #:
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| 62
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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|
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| C 7391
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| S. Wasserman
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| Vol #:
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| 307
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| |
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| 1998P-1121
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| Grated Parmesan Cheese Deviating from Identity standard
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|
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| ANS
7
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| HFS-200 to The Kroger Company
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| Vol #:
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| 1
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| |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 363
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| P. Horvath, MD
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| Vol #:
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| 162
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| C 364
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| R. Heimburger,MD,FACS
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| Vol #:
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| 162
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| C 365
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| L. Ruggles
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| Vol #:
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| 233
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| C 366
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| D. Shively
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| Vol #:
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| 233
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| EMC 3538
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| C. Robinson
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| Vol #:
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| 166
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| |
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| EMC 3539
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| H.Tuttle
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| Vol #:
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| 166
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| EMC 3540
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| G. Crouse
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| Vol #:
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| 166
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| EMC 3541
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| S.G. Thomas
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| Vol #:
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| 166
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| EMC 3542
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| D. Wheelin
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| Vol #:
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| 166
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| EMC 3543
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| P. Siri
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| Vol #:
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| 166
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| EMC 3544
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| S. Tognoli
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| Vol #:
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| 166
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| EMC 3545
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| M. Priest
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| Vol #:
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| 166
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| EMC 3546
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| G. Wiegand
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| Vol #:
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| 166
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| EMC 3547
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| S. Shand
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| Vol #:
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| 166
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| EMC 3548
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| R. Dean
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| Vol #:
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| 166
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| EMC 3549
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| R. Sundin
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| Vol #:
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| 166
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| EMC 3550
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| E. Zhurbinskaya
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| Vol #:
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| 166
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| EMC 3551
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| H. Olson
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| Vol #:
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| 166
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| EMC 3552
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| S. Musser
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| Vol #:
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| 166
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| EMC 3553
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| C. S. Perricelli
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| Vol #:
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| 166
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| EMC 3554
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| J. Hanks
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| Vol #:
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| 166
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| EMC 3555
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| D. Chadbourne
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| Vol #:
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| 166
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| EMC 3556
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| B. Kerr
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| Vol #:
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| 166
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| EMC 3557
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| R. Fields
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| Vol #:
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| 166
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| |
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| EMC 3558
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| L. Goodman
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| Vol #:
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| 166
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| EMC 3559
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| A. H. Warren
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| Vol #:
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| 166
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| EMC 3560
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| L. A. Kozak
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| Vol #:
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| 166
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| EMC 3561
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| G. Imre
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| Vol #:
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| 166
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| EMC 3562
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| M.Holtzman
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| Vol #:
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| 166
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| EMC 3563
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| S. & A. Strassman
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| Vol #:
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| 166
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| EMC 3564
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| D.Hoker
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| Vol #:
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| 166
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| EMC 3565
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| C. Cook
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| Vol #:
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| 166
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| EMC 3566
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| A. Thompson
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| Vol #:
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| 166
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| EMC 3567
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| J. Edwards
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| Vol #:
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| 166
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| EMC 3568
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| C. Herder
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| Vol #:
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| 166
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| EMC 3569
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| C. Hanks
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| Vol #:
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| 166
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| EMC 3570
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| S. A. Thompson
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| Vol #:
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| 166
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| EMC 3571
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| L. Boynton
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| Vol #:
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| 166
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| EMC 3572
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| B. Donoho
|
| Vol #:
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| 166
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| EMC 3573
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| D. Franzen
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| Vol #:
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| 166
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| EMC 3574
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| S. Archbald
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| Vol #:
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| 166
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| EMC 3575
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| C. Zagorski
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| Vol #:
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| 166
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| EMC 3576
|
| S. Brown
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| Vol #:
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| 166
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| |
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| EMC 3577
|
| N. Sangiovese
|
| Vol #:
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| 166
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| EMC 3578
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| S. W. Aaron
|
| Vol #:
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| 166
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| EMC 3579
|
| G. Obkirchner
|
| Vol #:
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| 166
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| |
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|
| EMC 3580
|
| R. Olsen
|
| Vol #:
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| 166
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| |
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|
| EMC 3581
|
| L. Galcher
|
| Vol #:
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| 166
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| |
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|
| EMC 3582
|
| A. Carpenter
|
| Vol #:
|
| 166
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| |
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| EMC 3583
|
| D. Gould
|
| Vol #:
|
| 166
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| |
|
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| EMC 3584
|
| L. Breit
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3585
|
| C. O' brien
|
| Vol #:
|
| 166
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| |
|
|
| EMC 3586
|
| P. browder
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3587
|
| B. Fox
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3588
|
| K. E. May
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3589
|
| M. Bush
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3590
|
| D. Kat
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3591
|
| R. Hunt
|
| Vol #:
|
| 166
|
|
| | | | | | | |
| |
|
|
| EMC 3592
|
| M. A. King
|
| Vol #:
|
| 166
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| |
|
|
| EMC 3593
|
| E. Sandberg
|
| Vol #:
|
| 166
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| |
|
|
| EMC 3594
|
| S. Ellis
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3595
|
| A. D. Austin
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3596
|
| K. Hart
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3597
|
| V. Cusick
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3598
|
| L. Myrick
|
| Vol #:
|
| 166
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| |
|
|
| EMC 3599
|
| M. Berkman
|
| Vol #:
|
| 166
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| |
|
|
| EMC 3600
|
| G. & C. Waltershausen
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3601
|
| C. Sawyer
|
| Vol #:
|
| 166
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| |
|
|
| EMC 3602
|
| R. Seltzer
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3603
|
| B. Armstrong
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3604
|
| E. Markatos
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3605
|
| C. Dickason
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3606
|
| C. M. Loupe
|
| Vol #:
|
| 166
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| |
|
|
| EMC 3607
|
| S. Smith
|
| Vol #:
|
| 166
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| |
|
|
| EMC 3608
|
| G. E. Taylor
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3609
|
| L. Jones
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3610
|
| KC Curry
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3611
|
| W. Veith
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3612
|
| J. K. McConahey
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3613
|
| C. Iverson
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3614
|
| A. D. Snyder
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3615
|
| R. Witzky
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3616
|
| M. Hagerty
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3617
|
| J. Wittenberg
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3618
|
| J. Isler
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3619
|
| J. Isler
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3620
|
| K. Johnson
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3621
|
| J. Barley
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3622
|
| M. Henry
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3623
|
| A. Margosian
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3624
|
| J. A. Bazata
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3625
|
| H. Harmon
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3626
|
| D. Roth
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3627
|
| J. Lahman
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3628
|
| J. Lahman
|
| Vol #:
|
| 166
|
|
| | | | | | | |
| |
|
|
| EMC 3629
|
| J. Mitchell
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3630
|
| J. Gatliff
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3631
|
| J. Stange
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3632
|
| W. Ray
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3633
|
| A. Brown
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3634
|
| L. Spinale
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3635
|
| L. Rivin
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3636
|
| M. Swenson
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3637
|
| J. Goldberg
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3638
|
| J. Van Osdell
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3639
|
| J. Van Osdell
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3640
|
| F. Kern
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3641
|
| F. Kern
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3642
|
| F. G. Sonne
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3643
|
| F. G. Sonne
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3644
|
| B. Bushnell
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3645
|
| M. Dollar
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3646
|
| S. Willaims
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3647
|
| W. Watson
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3648
|
| P. Meyer
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3649
|
| M. Alex
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3650
|
| A. Graham
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3651
|
| L. Peckner
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3652
|
| H. Thurston
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3653
|
| H. Velez
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3654
|
| P. Notermann
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3655
|
| J. Holderness
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3656
|
| S. Harper
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3657
|
| M. Highers
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3658
|
| J. Fortaine
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3659
|
| A. Scott
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3660
|
| R.Rodeback
|
| Vol #:
|
| 166
|
| |
|
|
| EMC 3661
|
| P. Schulte
|
| Vol #:
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| 166
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| |
|
|
| EMC 3662
|
| E. Davisson
|
| Vol #:
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| 166
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| |
|
|
| EMC 3663
|
| L. Khan
|
| Vol #:
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| 166
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| |
|
|
| EMC 3664
|
| D. Morrison
|
| Vol #:
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| 166
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| |
|
|
| EMC 3665
|
| J. Compton
|
| Vol #:
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| 166
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| | | | | | | |
| |
|
|
| EMC 3666
|
| J. Mossman
|
| Vol #:
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| 166
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| |
|
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| EMC 3667
|
| M. McCullough
|
| Vol #:
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| 166
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| |
|
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| EMC 3668
|
| D. Cloud
|
| Vol #:
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| 166
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| |
|
|
| EMC 3669
|
| K. Fox
|
| Vol #:
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| 166
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| |
|
|
| EMC 3670
|
| J. Roldan
|
| Vol #:
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| 166
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| |
|
|
| EMC 3671
|
| R. Shelton
|
| Vol #:
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| 166
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| |
|
|
| EMC 3672
|
| G. Spitze
|
| Vol #:
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| 166
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| |
|
|
| EMC 3673
|
| S. Swayze
|
| Vol #:
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| 166
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| |
|
|
| EMC 3674
|
| T. Lindsey
|
| Vol #:
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| 166
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| |
|
|
| EMC 3675
|
| D. Reed
|
| Vol #:
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| 166
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| |
|
|
| EMC 3676
|
| M. B. Gierlach
|
| Vol #:
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| 166
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| |
|
|
| EMC 3677
|
| M. Rosser
|
| Vol #:
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| 166
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| |
|
|
| EMC 3678
|
| M. Nightsage
|
| Vol #:
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| 166
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| |
|
|
| EMC 3679
|
| A. Bork
|
| Vol #:
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| 166
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| |
|
|
| EMC 3680
|
| L. Korn
|
| Vol #:
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| 166
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| |
|
|
| EMC 3681
|
| M. Ham
|
| Vol #:
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| 166
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| |
|
|
| EMC 3682
|
| N. G. Berman
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3683
|
| M. Jones
|
| Vol #:
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| 166
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| |
|
|
| EMC 3684
|
| M. Hitchcock
|
| Vol #:
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| 166
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| |
|
|
| EMC 3685
|
| A. Raab
|
| Vol #:
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| 166
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| |
|
|
| EMC 3686
|
| J. D. Burch
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3687
|
| M. Shapiro
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3688
|
| B. Roe
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3689
|
| J. Orr
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3690
|
| N. & M. Schulz
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3691
|
| J. K. Erskine
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3692
|
| S. Handy
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3693
|
| P. Idol
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3694
|
| D. Kass
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3695
|
| R. Riley
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3696
|
| A. Patton
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3697
|
| E. White
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3698
|
| A. Krukovsky
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3699
|
| H. Cole
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3700
|
| L. Jackson
|
| Vol #:
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| 166
|
| |
|
|
| EMC 3701
|
| S. E. Heredia
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3702
|
| S. Carlough
|
| Vol #:
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| 167
|
|
| | | | | | | |
| |
|
|
| EMC 3703
|
| A. Fehlau
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3704
|
| S. Robinson
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3705
|
| S. Chamberlin
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3706
|
| K. Suchmann
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3707
|
| D. Blakelock
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3708
|
| E. Weinheimer
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3709
|
| R. Bosch
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3710
|
| L. Pruitt
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3711
|
| A. Siegel
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3712
|
| M. Greenberg
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3713
|
| P. A Diehl
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3714
|
| A. lima
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3715
|
| M. Suazo
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3716
|
| C. Lelli
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3717
|
| H. Beverly
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3718
|
| D. P. Schultz
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3719
|
| J. Schonebaum
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3720
|
| W. Trinh
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3721
|
| M. Fredericks
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3722
|
| M. Cockett
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3723
|
| J. W. Hoose
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3724
|
| J. C. Moore
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3725
|
| V. Stram
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3726
|
| R. Kosek
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3727
|
| S. Clark
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3728
|
| K .Huttler
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3729
|
| M. Perez
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3730
|
| R. Peerboom
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3731
|
| J. Kern
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3732
|
| M.Guerriero
|
| Vol #:
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| 162
|
| |
|
|
| EMC 3733
|
| K. Parfitt
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3734
|
| Dr. S. D. Frasier
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3735
|
| J. Bohren
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3736
|
| P. Williard
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3737
|
| K. Eaton
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3738
|
| E. & E. Hazard
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3739
|
| J. Stone
|
| Vol #:
|
| 167
|
|
| | | | | | | | |
| |
|
|
| EMC 3740
|
| J. Servais
|
| Vol #:
|
| 167
|
| |
|
|
| EMC 3741
|
| Wm. C. Smith
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3742
|
| R. F. Barrett
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3743
|
| L. McHenry
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3744
|
| M. Bernache
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3745
|
| C. Jacobs
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3746
|
| W. Oleksy
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3747
|
| M. Lahey
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3748
|
| M. Trombley
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3749
|
| V. Hemingway
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3750
|
| S. Merscher
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3751
|
| JP Maurandy
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3752
|
| S. Manning
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3753
|
| J. Galbreath
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3754
|
| C. Livesay
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3755
|
| R. Blackman-Bailey
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3756
|
| D. N. REynolds
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3757
|
| B. E. Suddarth
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3758
|
| N. Parker
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3759
|
| J. Chenoweth
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3760
|
| M. Pritchard
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3761
|
| L. Greenalagh
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3762
|
| S. Lalitananda
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3763
|
| T. Devine
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3764
|
| I Alexander
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3765
|
| P. Close
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3766
|
| Renee W.
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3767
|
| T. J. Davies Jr.
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3768
|
| J. P. Maher
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3769
|
| S. Horwitz
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3770
|
| H. Simpkins
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3771
|
| J. Rogers
|
| Vol #:
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| 167
|
| |
|
|
| EMC 3772
|
| L. Edwalds
|
| Vol #:
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| 167
|
| |
|
|
| 2002N-0275
|
| Bioterrorism Preparedness; Administrative Detention
|
| |
|
|
| REF
1
|
| OMB Review for 5/9/2003
|
| Vol #:
|
| 9
|
|
| |
|
| 2003D-0111
|
| Potassium Iodide Tablets Shelf Life Extension
|
|
| | | | | | | | |
| |
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2003D-0204
|
| Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations; Availability
|
| |
|
|
| C
1
|
| Aventis Pharmaceuticals, Inc. (Aventis)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
| |
|
|
| C
5
|
| Amgen
|
| Vol #:
|
| 1
|
| |
|
|
| C
6
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| C
7
|
| International Assn for Pharmaceutical Science and Technology (PDA)
|
| Vol #:
|
| 1
|
| |
|
|
| C
8
|
| Aventis Behring (Aventis)
|
| Vol #:
|
| 1
|
| |
|
|
| C
9
|
| Aventis Pharmaceuticals, Inc. (Aventis)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0493
|
| Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
|
| |
|
|
| C
2
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0338
|
| Obesity
|
| |
|
|
| C
18
|
| Honorable Rosa L. DeLauro
|
| Vol #:
|
| 10
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| C 85
|
| J. Korsmo
|
| Vol #:
|
| 9
|
| |
|
|
| 2003P-0266
|
| Lovenos(enoxaparin sodlium),NDA 20-164(90mg/0.6ml(product number 006),was not withdrawn from sale for reasons of safety or effectiveness sponsored by Aventis Pharmaceuticalls inc.
|
|
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
| |
|
|
| C 55
|
| J. Leatherbee
|
| Vol #:
|
| 6
|
| |
|
|
| C 56
|
| K. Crupi
|
| Vol #:
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| 6
|
| |
|
|
| C 57
|
| C. Ostopoff
|
| Vol #:
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| 6
|
| |
|
|
| C 58
|
| N. Reyes
|
| Vol #:
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| 6
|
| |
|
|
| C 59
|
| K. Dalenberg
|
| Vol #:
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| 6
|
| |
|
|
| C 60
|
| D. Garlit
|
| Vol #:
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| 6
|
| |
|
|
| C 61
|
| F. Rosenstein
|
| Vol #:
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| 6
|
| |
|
|
| SUP
3
|
| Compassion Over Killing, Inc
|
| Vol #:
|
| 6
|
| |
|
|
| 2003Q-0559
|
| Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
|
| |
|
|
| C
5
|
| ACH Food Companies Inc
|
| Vol #:
|
| 6
|
| |
|
|
| EMC
3
|
| United Soybean Board (USB)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
4
|
| American Soybean Association
|
| Vol #:
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| 5
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|
|
