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| Dockets Entered
On December 18, 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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| 1995V-0312
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| Laser Light Show
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| 2000V-1247
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| Laser Light Show
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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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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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0498
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| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
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| 2006D-0246
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| Manufactured Food Regulatory Program Standards
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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-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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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-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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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-0255
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| discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons
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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-0518
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| Stop all approvals of medical devices and their components used for LASIK or place a moratorium on their use
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| 2006P-0519
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| Stop all approvals of medical devices used for implantable lens implants including, but not limited to Phakic IOLs (PIOLs) and Collamar Lenses or to place a moratorium on their use
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| 2006P-0520
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| Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)
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| 2006P-0522
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| Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
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| 2006V-0521
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| Laser Light Show
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| 1978N-0065
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| Skin Bleaching Drug Products
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| C
56
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| Beth Israel Deaconess Medical Center
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| Vol #:
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| 15
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| EC
140
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| Ms. Melanie Isaacson
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| Vol #:
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| 14
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| EC
141
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| Chicago Dermatological Society
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| Vol #:
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| 14
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| EC
142
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| UTSA Student Health Services
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| Vol #:
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| 14
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| EC
143
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| Ms. Auberrie Johnson
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| Vol #:
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| 14
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| EC
144
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| Mrs. Ann German
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| Vol #:
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| 14
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| EC
145
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| Dr. Todd Davis
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| Vol #:
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| 14
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| EC
146
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| Ms. Karen Grim
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| Vol #:
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| 14
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| EC
147
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| Mrs. Brenda Bolton
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| Vol #:
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| 14
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| EC
148
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| Mr. Stephen Jacob
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| Vol #:
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| 14
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| EC
149
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| Ms. Lorraine Vaughan
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| Vol #:
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| 14
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| EC
150
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| Mrs. Stephanie Rodrigue
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| Vol #:
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| 14
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| EC
151
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| Mrs. Jill Berner
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| Vol #:
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| 14
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| EC
152
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| Dr. Anne Lieu
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| Vol #:
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| 14
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| EC
153
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| Mrs. carolyn homan
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| Vol #:
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| 14
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| EC
154
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| Miss. Sheila Foreman
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| Vol #:
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| 14
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| EC
155
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| None
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| Vol #:
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| 14
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| 1995V-0312
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| Laser Light Show
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| VRA 8
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| FDA/CDRH to Laseronics Northwest dba Laseronics Design Interstellar
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| Vol #:
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| 1
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| 2000V-1247
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| Laser Light Show
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| VRA 7
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| FDA/CDRH to Lazer Wizardry
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| Vol #:
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| 1
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1399
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| A. Hileman
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| Vol #:
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| 259
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| 2002P-0122
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| Request Rulemaking on Functional Foods & Establish Adv. Com.
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| EC 2
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| Dr. John Vanderveen
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| Vol #:
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| 2
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| EC 3
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| International Food Additives Council
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| Vol #:
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| 2
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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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| EC 10
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| NDC Working Group
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| Vol #:
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| 3
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| EC 33273
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| Ms. Merry Schell
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| Vol #:
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| 197
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| EMC 4168
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| B. Carbone
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| Vol #:
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| 195
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| EMC 4169
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| L. Garrett
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| Vol #:
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| 195
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| EMC 4170
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| C. Richards
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| Vol #:
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| 195
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| EMC 4171
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| K. Bausch
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| Vol #:
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| 195
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| EMC 4172
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| A. Finlay
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| Vol #:
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| 195
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| EMC 4173
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| S. Nafegar
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| Vol #:
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| 195
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| EMC 4174
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| G. Piazza
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| Vol #:
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| 195
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| EMC 4175
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| B. Galletly
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| Vol #:
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| 195
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| EMC 4176
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| N. Eads
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| Vol #:
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| 195
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| EMC 4177
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| L. Waterfield
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| Vol #:
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| 195
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| EMC 4178
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| P. deDeugd
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| Vol #:
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| 195
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| EMC 4179
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| L. Schodtler
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| Vol #:
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| 195
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| EMC 4180
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| K. Strnad
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| Vol #:
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| 195
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| 2005P-0498
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| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
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| | | | | | | | |
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| |
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2006N-0061
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| Charging for Investigational Drugs
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| EC
1
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| Mr. Lawrence Silberman
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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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| C 1
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| S. Fink, MD
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| Vol #:
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| 1
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| EC
1
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| Mr. Lawrence Silberman
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| Vol #:
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| 1
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| EC
2
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| Ms. Laureen Wallace
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| Vol #:
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| 1
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| C
2
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| American Pet Products Manufacturers Association (APPMA)
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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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| C 2
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| Ciba Specialty Chemicals Corporation (Ciba)
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| Vol #:
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| 2
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| EC 25
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| Hollister-Stier Laboratories LLC
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| Vol #:
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| 2
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| EC 26
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| SAS
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| Vol #:
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| 2
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| EC 27
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| Northrop Grumman Corporation
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| Vol #:
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| 2
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| 2006P-0255
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| Discontinued formulation
of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued
for safety and efficacy reasons
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| LET 1
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| FDA/CDER to Orchid Healthcare
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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
447
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| Mrs. Kathy Tiura
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| Vol #:
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| 7
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| EC
448
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| Mr. Kevin Bierstedt
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| Vol #:
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| 7
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| 2006P-0518
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| Stop all approvals of medical devices and their components used for LASIK or place a moratorium on their use
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| ACK 1
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| FDA/DDM to Michael Patterson, Ph.D., BSEE
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| Vol #:
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| 1
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| CP 1
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| Michael Patterson, Ph.D., BSEE
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| Vol #:
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| 1
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| 2006P-0519
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| Stop all approvals of medical devices used for implantable lens implants including, but not limited to Phakic IOLs (PIOLs) and Collamar Lenses or to place a moratorium on their use
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| ACK 1
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| FDA/DDM to Michael Patterson, Ph.D., BSEE
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| Vol #:
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| 1
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| CP 1
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| Michael Patterson, Ph.D., BSEE
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| Vol #:
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| 1
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| 2006P-0520
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| Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)
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| ACK 1
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| FDA/DDM to SICOR Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP 1
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| SICOR Pharmaceuticals, Inc.
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| Vol #:
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| 1
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