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| Dockets Entered
On December 12, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1998D-0777
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| Investigating out of Specification(OOS)Test Results fr Pharm
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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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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| 2006E-0259
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| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
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| 2006E-0478
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| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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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-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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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-0179
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| Ban of Carcinogenic Potassium Bromate
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| 2006P-0242
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| Approval of any Budesonide Inhalation Suspension Product using Pulmicort Respules
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| 2006P-0508
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| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| 2006V-0509
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| Laser Light Show
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| 1978N-0036L
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| OTC Laxative
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| C
217
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| MADAUS GmbH, (Madaus)
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| Vol #:
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| 138
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| 1978N-0065
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| Skin Bleaching Drug Products
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| C 48
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| R. Barry, M.D.
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| Vol #:
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| 15
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| C 49
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| W. Heimer, II, M.D.
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| Vol #:
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| 15
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| C
50
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| American Osteopathic College of Dermatology
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| Vol #:
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| 15
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| C 51
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| B. Lin, MD
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| Vol #:
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| 15
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| EC
138
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| American Academy of Dermatology
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| Vol #:
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| 14
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| 1998D-0777
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| Investigating out of Specification(OOS)Test Results fr Pharm
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| EC
1
Attachment
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| SST Corporation
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| Vol #:
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| 2
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| EXB 132
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| R-127 3/13/03: FDA Letter from Betty Collins
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| Vol #:
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| 138
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| EXB 133
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| R-128 4/3/03: TMJ Letter from Betty Collins
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| Vol #:
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| 139
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| EXB 134
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| R-129 4/9/03: Submission of Complaint Handling Procedures
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| Vol #:
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| 140
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| EXB 135
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| R-130 4/28/03: FDA Letter re: MDR From Betty Collins
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| Vol #:
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| 141
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| EXB 136
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| R-131 08/11/03: FDA Form 483
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| Vol #:
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| 142
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| EXB 137
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| R-132 08/25/03: TMJI Response to Form 483
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| Vol #:
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| 143
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| EXB 138
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| R-133 08/26/03: EIR Report from October 200 Inspection
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| Vol #:
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| 144
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| EXB 139
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| R-134 08/26/03: EIR Report from January 2001 Inspection
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| Vol #:
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| 145
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| EXB 140
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| R-135 2/24/04: FDA Warning Letter
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| Vol #:
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| 146
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| EXB 141
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| R-136 2/24/04: TMJI Response to FDA Warning Letter
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| Vol #:
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| 147
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| EXB 142
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| R-137 3/10/04: Transcript from FDA/TMJI Meeting
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| Vol #:
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| 148
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| EXB 143
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| R-138 3/22/04: TMJI Letter to Tom Warwick
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| Vol #:
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| 149
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| EXB 144
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| R-139 4/2/04: TMJI's Letter to Tom Warwick
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| Vol #:
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| 150
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| EXB 145
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| R-140 4/13/04: Teleconference Notes with Tom Warwick
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| Vol #:
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| 151
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| EXB 146
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| R-141 4/15/04: FDA Letter from Tom Warwick
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| Vol #:
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| 152
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| EXB 147
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| R-142 4/21/04: FDA Letter from Tom Warwick
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| Vol #:
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| 153
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| EXB 148
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| R-143 4/21/04: TMJI Letter to Commissioner Crawford
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| Vol #:
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| 154
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| EXB 149
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| R-144 5/17/04: TMJI Letter to Commissioner Crawford
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| Vol #:
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| 155
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| EXB 150
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| R-145 7/8/04: TMJI Letter to Commissioner Crawford
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| Vol #:
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| 156
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| EXB 151
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| R-146 7/14/04: FDA Letter from Belinda Collins
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| Vol #:
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| 157
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| EXB 152
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| R-147 7/19/04: Teleconference Notes with Paul Williams
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| Vol #:
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| 158
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| EXB 153
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| R-148 7/23/04: TMJI Letter to Belinda Collins
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| Vol #:
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| 159
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| EXB 154
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| R-149 7/26/04: TMJI Letter to Belinda Collins
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| Vol #:
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| 160
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| EXB 155
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| R-150 7/27/04: TMJI Letter to Commissioner Crawford
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| Vol #:
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| 161
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| EXB 156
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| R-151 8/12/04: TMJI Submits 5 MDRs
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| Vol #:
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| 162
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| EXB 157
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| R-152 9/7/04: FDA Letter from Daniel Schultz
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| Vol #:
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| 163
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| EXB 158
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| R-153 9/15/04: TMJI Letter to Daniel Schultz
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| Vol #:
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| 164
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| EXB 159
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| R-154 9/27/04: TMJI Letter to Daniel Schultz and Belinda Collins
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| Vol #:
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| 165
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| EXB 160
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| R-155 11/5/04: TMJI Letter to Cynthia Harris
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| Vol #:
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| 166
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| EXB 161
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| R-156 11/10/04: FDA Letter to Daniel Schultz
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| Vol #:
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| 167
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| EXB 162
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| R-157 11/16/04: TMJ Letter to Daniel Schultz
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| Vol #:
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| 168
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| EXB 163
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| R-158 6/8/05: Congressman Letter to Daniel Schultz
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| Vol #:
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| 169
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| EXB 164
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| R-159 7/14/05: Civil Money Complaint
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| Vol #:
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| 170
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| EXB 165
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| R-160 7/21/05: Letter from Sheila D. Walcoff
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| Vol #:
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| 171
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| C 10
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| National Council for Prescription Drug Programs (NCPDP)
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| Vol #:
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| 3
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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|
| | | | | | | | |
|
| |
|
| 2006E-0259
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| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
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|
|
|
|
| LET
2
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0478
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| Patent Extension Application for NovoLog insulin aspart (rDNA origin) injection, U.S. Patent No. 5,618,913
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| LET
3
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| |
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| 2006N-0061
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| Charging for Investigational Drugs
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| REF 1
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| HF-26
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| Vol #:
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| 1
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| 2006N-0062
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| Expanded Access to Investigational Drugs for Treatment Use
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| REF 1
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| HF-26
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| Vol #:
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| 1
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| SUP 27
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| R. Siblerud
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| Vol #:
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| 34
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| SUP 28
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| DAMS, Intl
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| Vol #:
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| 35
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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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|
|
|
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| EC 21
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| Pharm Res
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| Vol #:
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| 1
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| 2006P-0179
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| Ban of Carcinogenic Potassium Bromate
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| LET
1
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| FDA/CFSAN to Yoon Ja Kim
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| Vol #:
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| 1
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| 2006P-0242
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| Approval of any Budesonide Inhalation Suspension Product using Pulmicort Respules
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| LET 1
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| FDA/CDER to Ropes & Gray
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| Vol #:
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| 1
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| |
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| 2006P-0508
|
| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| ACK 1
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| FDA/DDM to Charles E. Weber
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| Vol #:
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| 1
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| CP 1
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| Charles E. Weber
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| Vol #:
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| 1
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| 2006V-0509
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| Laser Light Show
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| ACK 1
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| FDA / DDM to LFI International
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| Vol #:
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| 1
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| VAR 1
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| LFI International
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| Vol #:
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| 1
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