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| Dockets Entered
On October 23, 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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| 2001E-0213
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| Angiomax, Patent Term Extension Application, No. 5,196,404
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2005P-0409
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| Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
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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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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| 2006P-0173
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| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
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| 2006P-0390
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| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
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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-0422
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| Refrain from approval of any ANDA for metoprolol succinate extended release 100 mg and 200 mg tablets subsequent to ANDA 76-640 from KV Pharmaceutical
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| 2006P-0428
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| Combivent (ipratropium bromide and albuterol sulfate)
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EMC 1
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| T. Findlay
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| Vol #:
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| 4
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| EMC 2
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| Dr. J. Sinsky
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| Vol #:
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| 4
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| 2001E-0213
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| Angiomax, Patent Term Extension Application, No. 5,196,404
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| CR 1
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| FDA/DDM to Generamedix Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 726
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| Mission Possible International
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| Vol #:
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| 10
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1361
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| H. Petersen, MBA
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| Vol #:
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| 12
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| EMC 1362
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| J. Cefali
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| Vol #:
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| 12
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| 2005P-0409
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| Refuse Approval of NDA for Olopatadine Hydrochloride Nasal Spray
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| PDN 1
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| FDA/CDER to Sterne, Kessler, Goldstein & Fox, P.L.L.C.
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| Vol #:
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| 1
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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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| EMC 4017
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| K. Walker
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| Vol #:
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| 195
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| EMC 4018
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| T. Moss
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| Vol #:
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| 195
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| EMC 4019
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| C. Malecki
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| Vol #:
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| 195
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| EMC 4020
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| J. Russo
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| Vol #:
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| 195
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| EMC 4021
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| K. Christian
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| Vol #:
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| 195
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| EMC 4022
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| L. Harper
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| Vol #:
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| 195
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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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| EMC 401
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| M. Newell
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| Vol #:
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| 13
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| EMC 402
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| M. Newell
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| Vol #:
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| 13
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| EMC 403
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| M. Newell
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| Vol #:
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| 13
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| EMC 404
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| M. Newell
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| Vol #:
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| 13
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| EMC 405
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| EMC 406
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| A. Brockman, BSN, DDS
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| Vol #:
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| 13
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| EMC 407
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| EMC 408
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| EMC 409
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| EMC 410
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| EMC 411
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| EMC 412
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| EMC 413
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| EMC 414
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| |
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| EMC 415
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| M. Newell
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| Vol #:
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| 13
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| EMC 416
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| M. Newell
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| Vol #:
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| 13
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| EMC 417
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| M. Newell
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| Vol #:
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| 13
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| EMC 418
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| M. Newell
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| Vol #:
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| 13
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| EMC 419
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| M. Newell
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| Vol #:
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| 13
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| EMC 420
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| M. Newell
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| Vol #:
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| 13
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| EMC 421
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| No signature
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| Vol #:
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| 13
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| EMC 422
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| A. Parlato
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| Vol #:
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| 13
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| EMC 423
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| C. Brown
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| Vol #:
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| 13
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| EMC 424
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| D. Stahley
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| Vol #:
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| 13
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| EMC 425
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| C. Brown
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| Vol #:
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| 13
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| EMC 426
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| C. Brown
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| Vol #:
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| 13
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| EMC 427
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| C. Brown
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| Vol #:
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| 13
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| EMC 428
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| C. Brown
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| Vol #:
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| 13
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| EMC 429
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| C. Brown
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| Vol #:
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| 13
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| EMC 430
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| C. Brown
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| Vol #:
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| 13
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| EMC 431
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| C. Brown
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| Vol #:
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| 13
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| EMC 432
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| B. Wilkie
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| Vol #:
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| 13
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| EMC 433
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| Consumers for Dental Choice
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| Vol #:
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| 13
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| EMC 434
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| C. Brown
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| Vol #:
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| 13
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| | | | | | | | |
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| EMC 435
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| C. Brown
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| Vol #:
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| 13
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| EMC 436
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| D. devine
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| Vol #:
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| 13
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| EMC 437
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| A. Rust, DMD, MPA
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| Vol #:
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| 13
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| EMC 438
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| J. Duncan
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| Vol #:
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| 13
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| EMC 439
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| D. Moore, PhD
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| Vol #:
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| 13
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| EMC 440
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| P. Nupponen, DMD, MAGD
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| Vol #:
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| 13
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| EMC 441
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| M. Porter
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| Vol #:
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| 13
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| EMC 442
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| M. Koerner
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| Vol #:
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| 13
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| EMC 443
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| Dr. P. Gilbert
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| Vol #:
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| 13
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| EMC 444
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| F. Koss
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| Vol #:
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| 13
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| EMC 445
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| Consumers for Dental Choice
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| Vol #:
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| 13
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| EMC 446
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| J. Adams
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| Vol #:
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| 13
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| EMC 447
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| M. Gossweiler, DDS et al
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| Vol #:
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| 13
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| EMC 448
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| J. Bryan
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| Vol #:
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| 13
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| EMC 449
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| S. Machado
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| Vol #:
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| 13
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| EMC 450
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| S. Duffy, J.D.
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| Vol #:
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| 13
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| EMC 451
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| S. Hines
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| Vol #:
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| 13
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| |
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| EMC 68
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| J. Calkins
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| Vol #:
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| 1
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| EMC 69
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| M. Allen
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| Vol #:
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| 1
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| EMC 70
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| A. Skorupski
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| Vol #:
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| 1
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| EMC 71
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| C. Wrinn
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| Vol #:
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| 1
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| EMC 72
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| L. Sada
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| Vol #:
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| 1
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| EMC 73
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| D. Swanson
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| Vol #:
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| 1
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| EMC 74
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| J. Kahler
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| Vol #:
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| 1
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| EMC 75
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| J. Butts
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| Vol #:
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| 1
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| EMC 76
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| D. Bromley
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| Vol #:
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| 1
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|
| |
|
| 2006P-0173
|
| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
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|
|
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|
|
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| |
|
|
| LET 1
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| FDA/CDER to Wyeth Pharmaceuticals
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| Vol #:
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| 1
|
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|
|
| 2006P-0390
|
| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
|
| |
|
|
| EMC 1
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| No signature
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| Vol #:
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| 1
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| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
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| C 9
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| C. Dilfer
|
| Vol #:
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| 1
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| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
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| EMC 1
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| R. Gerbo
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| Vol #:
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| 2
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| EMC 2
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| Y. Chamberlin
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| Vol #:
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| 2
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| 2006P-0422
|
| Refrain from approval of any ANDA for metoprolol succinate extended release 100 mg and 200 mg tablets subsequent to ANDA 76-640 from KV Pharmaceutical
|
| |
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| CR 1
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| FDA/DDM to KV Pharmaceutical Co.
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| Vol #:
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| 1
|
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| 2006P-0428
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| Combivent (ipratropium bromide and albuterol sulfate)
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| ACK 1
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| FDA/DDM to Boehringer Ingelheim Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP 1
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| Boehringer Ingelheim Pharmaceuticals, Inc.
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| Vol #:
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| 1
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