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| Dockets Entered
On December 14, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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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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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006N-0061
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| Charging for Investigational Drugs
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| 2006N-0416
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| Use of Ozone-Depleting Substances; Removal of Essential Use Designations
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0442
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
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| 2006P-0444
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| Stay the potential grant effective approval of ANDA for 77-536 for moexipril hydrochloride tablets
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| 2006P-0510
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| ANDA Suitability for Propoxyphene Hydrochloride 65 mg and Acetaminophen 325 mg Tablets
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| 2006P-0511
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| Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
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| 2006P-0513
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| Determine that the Reference Listed Drug, Hydrochlorothiazide Tablets USP 100 mg, was voluntarily discontinued from sale in the US for reasons other than safety or effectiveness
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC
139
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| DERMAdoctor
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| 14
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT
772
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| Statistical Report - Month of November 2006
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| Vol #:
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| 55
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| EXB 170
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| R-165 L.J. Broutman & Assoc. Material Characterization File 53-924)
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| Vol #:
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| 176
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| EXB 171
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| R-166 Structural Performance Evaluation of TMJ Temporomandibular Joint Prostheses
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| Vol #:
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| 177
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| EXB 172
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| R-167 Fenite Element Analysis of the Christensen/Chase Condylar Prostheses
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| Vol #:
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| 178
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| EXB 173
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| R-168 Structural Performance Evaluation of the TMJ Metal Condylar Prosthesis, by Design Sciences
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| Vol #:
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| 179
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| EXB 174
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| R-169 Final Report: Fenite Element Analysis of the TMJ Condylar Component
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| Vol #:
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| 180
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| EXB 175
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| R-170 An In Vivo Determination of Kinematics and Kinetics of the TMJ (Final Report )
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| Vol #:
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| 181
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| EXB 176
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| R-171 Final Report: Fatigue Testing of TMJ Implant System
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| Vol #:
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| 182
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| EXB 177
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| R-172 Final Report: Fatigue Testing of TMJ Implant System
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| Vol #:
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| 183
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| EXB 178
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| R-173 Factographic Analysis of TMJ ImplantsProstheses by Hauser Laboratories
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| Vol #:
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| 184
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| EXB 179
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| R-174 Report for TMJ Implant Inc. Particle from Pin on Disk Tests
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| Vol #:
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| 185
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| EXB 180
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| R-175 Final Report: Wear Testing of TMJ Implant System
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| Vol #:
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| 186
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| EXB 181
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| R-176 The Wear of Metal-Metal and Acrylic-Metal Total Temporomandibular Joints
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| Vol #:
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| 187
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| EXB 182
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| R-177 Wear Facet Analysis Rev A
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| Vol #:
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| 188
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| EXB 183
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| R-178 Temporomandibular Joint Arthroplasty Using Metal on Metal
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| Vol #:
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| 189
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| EXB 184
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| R-179 A Report for Reciprocating Wear Testing of a PMMA Temporomandibular Joint (404-302.05
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| Vol #:
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| 190
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| EXB 185
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| R-180 Wear Testing TMJ Implants' Fossa-Eminence and Condylar Prosthesis
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| Vol #:
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| 191
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| EXB 186
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| R-181 Scanning Electron Microscope Study of Excised Cobalt-Chromium Temporomandibular Impla
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| Vol #:
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| 192
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| EXB 187
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| R-182 PMMA/Metal Testing Bench Test Stress Analysis
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| Vol #:
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| 193
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| EXB 188
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| R-183 A Three-Dimensional Mathematical Model of Temporamandibular Joint Loading
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| Vol #:
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| 194
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| EXB 189
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| R-184 Static Load Testing of TMJ Implant Pairs with Cobalt -Chromium and PMMA Articular He
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| Vol #:
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| 195
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| EXB 190
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| R-185 The Effect of Location of the Pull-out Load of Condylar Bone Screws
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| Vol #:
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| 196
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| EXB 191
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| R-186 Mating Tolerances of Condyle/Fossa Components of the Christensen-Chase TMJ Implant
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| Vol #:
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| 197
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| EXB 192
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| R-186 Mating Tolerances of Condyle/Fossa Components of the Christensen-Chase TMJ Implant
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| Vol #:
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| 198
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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
3
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| Critical Connection
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| Vol #:
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| 1
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| C 208
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| E. Best, RN
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| Vol #:
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| 12
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| C 209
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| R and L Larson
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| Vol #:
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| 12
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| C 210
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| J and H Costello
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| Vol #:
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| 12
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| C 211
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| M. Vilim
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| Vol #:
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| 12
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| C 212
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| M. Velosa
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| Vol #:
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| 12
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| C 213
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| M. Gillespie
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| Vol #:
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| 12
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| C 214
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| Dr. Richard J. Ohm
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| Vol #:
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| 12
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| C 215
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| T. Ehlinger
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| Vol #:
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| 12
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| C 216
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| H and M Pahren
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| Vol #:
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| 12
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| C 217
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| R. Thoman
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| Vol #:
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| 12
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| C 218
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| M. Mann
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| Vol #:
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| 12
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| C 219
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| C. Suriano
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| Vol #:
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| 12
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| C 220
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| L. Israel
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| Vol #:
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| 12
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| C 221
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| A. Bell
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| Vol #:
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| 12
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| C 222
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| C. Buckley
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| Vol #:
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| 12
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| C 223
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| D. Damiano
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| Vol #:
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| 12
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| C 224
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| N. Cougher
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| Vol #:
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| 12
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| C 225
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| L. Diehl
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| Vol #:
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| 12
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| C 226
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| E. Adams
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| Vol #:
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| 12
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| C 227
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| P. Juergens
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| Vol #:
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| 12
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| C 228
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| P. Schlitz
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| Vol #:
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| 12
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| | | | | | | | |
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| REF
1
Attachment
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| HF-26
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| Vol #:
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| 1
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| APE 3
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| Alston & Bird, LLP
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| Vol #:
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| 1
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| C 1
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| Comprehensive Clinical Trials, LLC
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| Vol #:
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| 1
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| EC 22
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| Dr. S. Albert Edwards
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| Vol #:
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| 2
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| EC 23
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| Northrop Grumman Corporation
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| Vol #:
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| 2
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| EMC 1
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| NGS, Newtech Global Soluctions LLC
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| Vol #:
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| 1
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| LST 1
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| Panelists for the Part 15 Public Hearing
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| Vol #:
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| 1
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| LST 2
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| Part 15 Public Hearing Schedule
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| Vol #:
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| 1
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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|
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| EC
12
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| Mrs. Margaret Lynch
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| EC
445
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| Mr. leslie swift
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| Vol #:
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| 7
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| SUP
1
Attachments
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| Center for Food Safety
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| Vol #:
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| 2
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| 2006P-0442
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
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| C 2
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| 2006P-0444
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| Stay the potential grant effective approval of ANDA for 77-536 for moexipril hydrochloride tablets
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| LET 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0510
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| ANDA Suitability for Propoxyphene Hydrochloride 65 mg and Acetaminophen 325 mg Tablets
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| ACK 1
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| FDA / DDM to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP 1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2006P-0511
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| Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
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| ACK 1
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| FDA/DDM to Kleinfeld, Kaplan and Becker, LLP
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| Vol #:
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| 1
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| PSA 1
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| Kleinfeld, Kaplan and Becker, LLP
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| Vol #:
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| 1
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| 2006P-0513
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| Determine that the Reference Listed Drug, Hydrochlorothiazide Tablets USP 100 mg, was voluntarily discontinued from sale in the US for reasons other than safety or effectiveness
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| ACK 1
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| FDA/DDM to Caraco Pharmaceutical Laboratories, Ltd.
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| Vol #:
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| 1
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| CP 1
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| Caraco Pharmaceutical Laboratories, Ltd.
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| Vol #:
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| 1
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