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| Dockets Entered
On October 18, 2006
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| Docket #
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| Title
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| 1997D-0318
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| Revised Precautionary Measure to Reduce Transmission of CJD
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| |
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| 2001E-0213
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| Angiomax, Patent Term Extension Application, No. 5,196,404
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| |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003E-0146
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| Patent Extension Application for RELPAX, No. 5,545,644
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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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| 2004D-0228
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| Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV'
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| |
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| 2004E-0039
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| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
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| 2005E-0235
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| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
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| 2005E-0238
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| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
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| 2005E-0239
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| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
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| 2005E-0246
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| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
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| 2005E-0256
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| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
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| |
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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
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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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| |
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| |
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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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| |
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| |
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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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| |
|
|
| 2006M-0343
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| P050010 - PRODISC-L Total Disc Replacement
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| |
|
|
| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| |
|
|
| 2006N-0219
|
| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
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| |
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| |
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| 2006P-0124
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| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
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| |
|
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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-0361
|
| Deny Request to switch ketotifen fumarate ophthalmic solution, 0.025%
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| |
|
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| 2006P-0387
|
| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
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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"
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| |
|
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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-0403
|
| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
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|
|
| 1997D-0318
|
| Revised Precautionary Measure to Reduce Transmission of CJD
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| C 38
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| University of Iowa Hospitals and Clinics
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| Vol #:
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| 4
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| EC 14
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| AABB
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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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| | | | | | | | |
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| ACK 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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| |
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| CP 1
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| Generamedix Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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| C 2097
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| Form Letters
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| Vol #:
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| 350
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| |
|
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| |
|
|
| EMC 718
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| R. Ulrich
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| Vol #:
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| 10
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| |
|
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| EMC 719
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| Mission Possible International
|
| Vol #:
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| 10
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| |
|
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| EMC 720
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| Mission Possible International
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| Vol #:
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| 10
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| |
|
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| EMC 721
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| Mission Possible International
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| Vol #:
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| 10
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| |
|
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| EMC 722
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| Mission Possible International
|
| Vol #:
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| 10
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| |
|
|
| EMC 723
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| Mission Possible International
|
| Vol #:
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| 10
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| |
|
|
| EMC 724
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| Mission Possible International
|
| Vol #:
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| 10
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| |
|
|
| EMC 725
|
| Calorie Control Council
|
| Vol #:
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| 10
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| |
|
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| 2003E-0146
|
| Patent Extension Application for RELPAX, No. 5,545,644
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| |
|
|
| LET 5
|
| 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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| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| |
|
|
| EMC 1359
|
| K. Carlson
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| Vol #:
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| 12
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| |
|
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| EMC 1360
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| M. Elmer
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| Vol #:
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| 12
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| |
|
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| 2004D-0228
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| Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV'
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| |
|
|
| GDL 2
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| Guidance
|
| Vol #:
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| 1
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| |
|
|
| NAD 2
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| FDA
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| Vol #:
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| 1
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| |
|
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| 2004E-0039
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| Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
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| |
|
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
| |
|
| 2005E-0235
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| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
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| |
|
|
| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2005E-0238
|
| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
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| |
|
|
| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2005E-0239
|
| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
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| |
|
|
| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2005E-0246
|
| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
|
| |
|
|
| LET 6
|
| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
| | | | | | | | |
|
|
|
| 2005E-0256
|
| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
|
| |
|
|
| LET 6
|
| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2005P-0402
|
| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
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|
|
|
|
|
|
|
|
| C 4
|
| National Alliance on Mental Illness (NAMI)
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| Vol #:
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| 5
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| |
|
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| LET 2
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| FDA/CDER to National Alliance on Mental Illness (NAMI)
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| Vol #:
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| 5
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| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
|
|
| EMC 4008
|
| B. Peeler
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| Vol #:
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| 195
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| |
|
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| EMC 4009
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| B. Peeler
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| Vol #:
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| 195
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| |
|
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| EMC 4010
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| C. Robertson
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| Vol #:
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| 195
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| |
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| EMC 4011
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| S. Turnblom
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| Vol #:
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| 195
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| |
|
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| EMC 4012
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| D. Field
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| Vol #:
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| 195
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| |
|
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| EMC 4013
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| R. Beaulieu
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| Vol #:
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| 195
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| |
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| EMC 4014
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| M. Lenker
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| Vol #:
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| 195
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| |
|
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| EMC 4015
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| C. Dougherty
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| Vol #:
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| 195
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| |
|
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| EMC 4016
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| R. Sammarco
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| Vol #:
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| 195
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| |
|
|
| 2006D-0331
|
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
|
|
|
| EC 38
|
| Methodist Healthcare
|
| Vol #:
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| 2
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| |
|
|
| EC 39
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| Mr. Sean Davis
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| Vol #:
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| 2
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| |
|
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| EC 40
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| Dr. Richard Levine
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| Vol #:
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| 2
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| |
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| EC 41
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| Dr. E Brooke Lerner
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| Vol #:
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| 2
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| |
|
|
| 2006D-0336
|
| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
|
| |
|
|
| EC 4
|
| Mr. Kevin McNamara
|
| Vol #:
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| 1
|
| |
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| EC 5
|
| GHC Technologies, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0383
|
| 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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|
|
|
|
|
|
|
|
| EC 2
|
| Mr. Walter Weber
|
| Vol #:
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| 1
|
| |
|
|
| 2006M-0343
|
| P050010 - PRODISC-L Total Disc Replacement
|
| |
|
|
| CR 1
|
| Synthes Spine Co., L. P.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0107
|
| FDA-Regulated Products Containing Nanotechnology Materials
|
| |
|
|
| EC 18
|
| finding1cure@yahoogroups.com
|
| Vol #:
|
| 12
|
|
| | | | | | | | |
|
| |
|
| EC 19
|
| Mr. Paul Tuff
|
| Vol #:
|
| 12
|
| |
|
|
| EC 20
|
| Mrs. COLIN Mathilde
|
| Vol #:
|
| 12
|
|
| |
|
| 2006N-0219
|
| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
|
| |
|
|
| EC 4
|
| Mr. Philip Anthony
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
| |
|
|
| EC 71
|
| Dental Care
|
| Vol #:
|
| 13
|
| |
|
|
| EC 72
|
| Dental Care
|
| Vol #:
|
| 3
|
| |
|
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| EC 73
|
| Dental Care
|
| Vol #:
|
| 3
|
| |
|
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| EC 74
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| Dental Care
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| Vol #:
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| 3
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| |
|
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| EC 75
|
| Dental Care
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| Vol #:
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| 3
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| |
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| EC 76
|
| Mom
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| Vol #:
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| 3
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| |
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| EC 77
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| Pediatric Physical Therapist
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| Vol #:
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| 3
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| |
|
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| EC 78
|
| The Centre for Dentistry
|
| Vol #:
|
| 3
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| |
|
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| EC 79
|
| Dennis L Anderson DDS
|
| Vol #:
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| 3
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| |
|
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| EC 80
|
| Dental Care
|
| Vol #:
|
| 3
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| |
|
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| EC 81
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| Dental Care
|
| Vol #:
|
| 3
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| |
|
|
| EC 82
|
| Mrs. LENOA WILLIAMSON
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| Vol #:
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| 3
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| |
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| EMC 397
|
| J. Wilson, Jr., M.D., FAAFP, FAAEM, DIBEM, DABNT, DABCMT
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| Vol #:
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| 6
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| |
|
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| EMC 398
|
| J. Blanco
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| Vol #:
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| 6
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| |
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| EMC 399
|
| F. Levy
|
| Vol #:
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| 6
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| |
|
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| EMC 400
|
| S. Rogers
|
| Vol #:
|
| 6
|
| |
|
|
| 2006P-0124
|
| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
|
| |
|
|
| C 3
|
| D. Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0158
|
| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
|
| |
|
|
| EMC 37
|
| Form Letters
|
| Vol #:
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| 3
|
| |
|
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| EMC 38
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| E. Arellano
|
| Vol #:
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| 1
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| |
|
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| EMC 39
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| K. Boone
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| Vol #:
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| 1
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| EMC 40
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| J. Gunn
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| Vol #:
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| 1
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| EMC 41
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| S. Outlaw
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| Vol #:
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| 1
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| |
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| EMC 42
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| K. Pearsall
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| Vol #:
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| 1
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| EMC 43
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| J. Jenainati
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| Vol #:
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| 1
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| |
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| EMC 44
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| M. LaBerge
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| Vol #:
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| 1
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| EMC 45
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| D. Stone
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| Vol #:
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| 1
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| EMC 46
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| D. Livengood
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| Vol #:
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| 1
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| EMC 47
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| Carole W.
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| Vol #:
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| 1
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| EMC 48
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| P. Morris
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| Vol #:
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| 1
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| |
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| EMC 49
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| J. Frazier
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| Vol #:
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| 1
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| EMC 50
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| S. Weyand
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| Vol #:
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| 1
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| EMC 51
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| J. Coccia
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| Vol #:
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| 1
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| EMC 52
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| E. Barron
|
| Vol #:
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| 1
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| |
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| EMC 53
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| J. Zenos
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| Vol #:
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| 1
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| EMC 54
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| J. Wang
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| Vol #:
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| 1
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| EMC 55
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| D. Russell
|
| Vol #:
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| 1
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| |
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| EMC 56
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| R. Newman
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| Vol #:
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| 1
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| |
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| EMC 57
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| K. Croteau
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| Vol #:
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| 1
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| |
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| EMC 58
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| C. Meyer
|
| Vol #:
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| 1
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| |
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| EMC 59
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| J. Rossi
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| Vol #:
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| 1
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| |
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| EMC 60
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| K. Foote
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| Vol #:
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| 1
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| |
|
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| EMC 61
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| K. Russell
|
| Vol #:
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| 1
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| EMC 62
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| A. Sheldon
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| Vol #:
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| 1
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| |
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| EMC 63
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| A. Swalve
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| Vol #:
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| 1
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| |
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| EMC 64
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| K. Houston
|
| Vol #:
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| 1
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| |
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| EMC 65
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| L. Clifford
|
| Vol #:
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| 1
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| |
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| EMC 66
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| R. Ulrich
|
| Vol #:
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| 1
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| |
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| EMC 67
|
| A. Stature
|
| Vol #:
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| 1
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| |
|
|
| 2006P-0361
|
| Deny Request to switch ketotifen fumarate ophthalmic solution, 0.025%
|
| |
|
|
| C 1
|
| Novartis Ophthalmics
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0387
|
| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
|
| |
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 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"
|
| |
|
|
| EC 4
|
| Mr. Jerry Staton
|
| Vol #:
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| 1
|
| |
|
|
| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| |
|
|
| C 6
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| M. Rosenberg
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| Vol #:
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| 1
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| |
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| C 7
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| R. Claypool
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| Vol #:
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| 1
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| |
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| C 8
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| M. Bean
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| Vol #:
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| 1
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| |
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| EC 68
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| Baltimore Green Party
|
| Vol #:
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| 2
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| |
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| EC 69
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| Ms. Dianne Marlow
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| Vol #:
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| 2
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| |
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| EC 70
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| MFA
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| Vol #:
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| 2
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| | | | | | | |
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| EC 71
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| Ms. stephanie rubin
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| Vol #:
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| 2
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| |
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| EC 72
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| Mrs. Jennifer Christensen
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| Vol #:
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| 2
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| |
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| EC 73
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| Ms. Melissa Koslowsky
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| Vol #:
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| 2
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| |
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| EC 74
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| Mr. mike morf
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| Vol #:
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| 2
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| |
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| EC 75
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| Miss. Megan Brosh
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| Vol #:
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| 2
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| |
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| EC 76
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| Ms. R. Gindin-Clarke
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| Vol #:
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| 2
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| |
|
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| EC 77
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| University of Rochester
|
| Vol #:
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| 2
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| |
|
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| EC 78
|
| Miss. Shalini Wickramatilake
|
| Vol #:
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| 2
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| |
|
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| EC 79
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| Miss. Amy Johnson
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| Vol #:
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| 2
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| |
|
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| EC 80
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| Miss. Jennifer Leighton
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| Vol #:
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| 2
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| |
|
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| EC 81
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| Miss. Emily Zaner
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| Vol #:
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| 2
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| |
|
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| EC 82
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| Ms. Jennifer DeLorge McKeown
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| Vol #:
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| 2
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| |
|
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| EC 83
|
| Mr. Benjamin Davidow
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| Vol #:
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| 2
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| |
|
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| EC 84
|
| Mr. David Betts
|
| Vol #:
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| 2
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| |
|
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| EC 85
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| Ms. Louise McGauley
|
| Vol #:
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| 2
|
| |
|
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| EC 86
|
| Dr. Chris Cobb
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| Vol #:
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| 2
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| |
|
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| EC 87
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| Mr. Joshua Anders
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| Vol #:
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| 2
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| |
|
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| EC 88
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| Ms. Jillian Marr
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| Vol #:
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| 2
|
| |
|
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| EC 89
|
| Ms. L Parker
|
| Vol #:
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| 2
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| |
|
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| EC 90
|
| Mr. Mike Pendleton
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| Vol #:
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| 2
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| |
|
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| EC 91
|
| Mrs. Deborah Gray
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| Vol #:
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| 2
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| |
|
|
| EC 92
|
| NRV-CARE, TREE
|
| Vol #:
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| 2
|
| |
|
|
| EC 93
|
| Ms. Heather Muchow
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| Vol #:
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| 2
|
| |
|
|
| EC 94
|
| Ms. CA Brooks
|
| Vol #:
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| 2
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| |
|
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| EC 95
|
| Miss. Dawn Yukus
|
| Vol #:
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| 2
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| |
|
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| EC 96
|
| Miss. alexa millinger
|
| Vol #:
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| 2
|
| |
|
|
| EC 97
|
| Ms. Stacey Ziegenhein
|
| Vol #:
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| 2
|
| |
|
|
| EC 98
|
| individual
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| Vol #:
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| 2
|
| |
|
|
| EC 99
|
| Compassion over Killing
|
| Vol #:
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| 2
|
| |
|
|
| EC 100
|
| Mr. Andrew Spagnolo
|
| Vol #:
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| 2
|
| |
|
|
| EC 101
|
| Ms. Sara Vandepeute
|
| Vol #:
|
| 2
|
| |
|
|
| EC 102
|
| Mr. Josef Reiter
|
| Vol #:
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| 2
|
| |
|
|
| EC 103
|
| Mr. Robert Gregory
|
| Vol #:
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| 2
|
| |
|
|
| EC 104
|
| Ms. Karolina Dembinska-Lemus
|
| Vol #:
|
| 2
|
| |
|
|
| EC 105
|
| Mocha Moms
|
| Vol #:
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| 2
|
| |
|
|
| EC 106
|
| Mrs. Heidi Gysan
|
| Vol #:
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| 2
|
| |
|
|
| EC 107
|
| Ms. Kerrie Kibling
|
| Vol #:
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| 2
|
|
| | | | | | | |
|
| |
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| EC 108
|
| Ms. Rachel Thompson
|
| Vol #:
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| 2
|
| |
|
|
| EC 109
|
| Ms. Erika Lloyd
|
| Vol #:
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| 2
|
| |
|
|
| EC 110
|
| Miss. Heidi Chan
|
| Vol #:
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| 2
|
| |
|
|
| EC 111
|
| Miss. MAGDA bOROWICZ
|
| Vol #:
|
| 2
|
| |
|
|
| EC 112
|
| Mr. Colin McDaniel
|
| Vol #:
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| 2
|
| |
|
|
| EC 113
|
| Ms. Erica Tokar
|
| Vol #:
|
| 2
|
| |
|
|
| EC 114
|
| Ms. Monique Fordham
|
| Vol #:
|
| 2
|
| |
|
|
| EC 115
|
| Dr. Aubrey Hanbicki
|
| Vol #:
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| 2
|
| |
|
|
| EC 116
|
| Mr. Matthew OLeary
|
| Vol #:
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| 2
|
| |
|
|
| EC 117
|
| Miss. Sara Ziegelbaum
|
| Vol #:
|
| 2
|
| |
|
|
| EC 118
|
| Mr. Christopher Maiuri
|
| Vol #:
|
| 2
|
| |
|
|
| EC 119
|
| Mr. howard kallem
|
| Vol #:
|
| 2
|
| |
|
|
| EC 120
|
| Mr. Alex Amato
|
| Vol #:
|
| 2
|
| |
|
|
| EC 121
|
| Mr. Praveen Mantena
|
| Vol #:
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| 2
|
| |
|
|
| EC 122
|
| Mr. Christopher Maurer
|
| Vol #:
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| 2
|
| |
|
|
| EC 123
|
| Ms. shana jahn
|
| Vol #:
|
| 2
|
| |
|
|
| EC 124
|
| Mr. James Boutin
|
| Vol #:
|
| 2
|
| |
|
|
| EC 125
|
| Mr. Dave Colburn
|
| Vol #:
|
| 2
|
| |
|
|
| EC 126
|
| Mr. Justin Fertig
|
| Vol #:
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| 2
|
| |
|
|
| EC 127
|
| Ms. Marcia Harrington
|
| Vol #:
|
| 2
|
| |
|
|
| EC 128
|
| Ms. Donna Jones
|
| Vol #:
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| 2
|
| |
|
|
| EC 129
|
| Ms. Susan THomas
|
| Vol #:
|
| 2
|
| |
|
|
| EC 130
|
| Mr. Christopher Thomas
|
| Vol #:
|
| 2
|
| |
|
|
| EC 131
|
| Ancient Soul Healing
|
| Vol #:
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| 2
|
| |
|
|
| EC 132
|
| AVMA
|
| Vol #:
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| 2
|
| |
|
|
| EC 133
|
| Mr. Jorge Mera
|
| Vol #:
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| 2
|
| |
|
|
| EC 134
|
| Animal Liberation League
|
| Vol #:
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| 2
|
| |
|
|
| EC 135
|
| Miss. Gabriele Johnson
|
| Vol #:
|
| 2
|
| |
|
|
| EC 136
|
| Ms. Amanda Carlozzi
|
| Vol #:
|
| 2
|
| |
|
|
| EC 137
|
| Ms. Julie Konop
|
| Vol #:
|
| 2
|
| |
|
|
| EC 138
|
| Ms. kathlen bartolomeo
|
| Vol #:
|
| 2
|
| |
|
|
| EC 139
|
| V H Usher MD PC
|
| Vol #:
|
| 2
|
| |
|
|
| EC 140
|
| Miss. Briana Wagner
|
| Vol #:
|
| 2
|
| |
|
|
| EC 141
|
| Ms. Sara Nemati
|
| Vol #:
|
| 2
|
| |
|
|
| EC 142
|
| Miss. Lauren Whiteman
|
| Vol #:
|
| 2
|
| |
|
|
| EC 143
|
| Ms. Lara Wagner
|
| Vol #:
|
| 2
|
| |
|
|
| EC 144
|
| Ms. Christopher Braudy
|
| Vol #:
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| 2
|
|
| | | | | | | | |
|
| |
|
| EC 145
|
| Mrs. sonia greene
|
| Vol #:
|
| 2
|
| |
|
|
| EC 146
|
| Ms. Kelly Ernst
|
| Vol #:
|
| 2
|
| |
|
|
| EC 147
|
| Ms. marianne lee
|
| Vol #:
|
| 2
|
| |
|
|
| EC 148
|
| Ms. Ashley Curran
|
| Vol #:
|
| 2
|
| |
|
|
| EC 149
|
| N/A
|
| Vol #:
|
| 2
|
| |
|
|
| EC 150
|
| Ms. Jennifer Granzow
|
| Vol #:
|
| 2
|
| |
|
|
| EC 151
|
| Ms. Margaret MacDonnell
|
| Vol #:
|
| 2
|
| |
|
|
| EC 152
|
| Miss. Stephanie DeMoss
|
| Vol #:
|
| 2
|
| |
|
|
| EC 153
|
| Ms. Shana Sandberg
|
| Vol #:
|
| 2
|
| |
|
|
| EC 154
|
| Ms. Heather Frei
|
| Vol #:
|
| 2
|
| |
|
|
| EC 155
|
| Dr. Barbara Butera
|
| Vol #:
|
| 2
|
| |
|
|
| EC 156
|
| Mr. James McDonough
|
| Vol #:
|
| 2
|
| |
|
|
| EC 157
|
| Miss. Allison Brown
|
| Vol #:
|
| 2
|
| |
|
|
| EC 158
|
| Ms. Iza Milani
|
| Vol #:
|
| 2
|
| |
|
|
| EC 159
|
| Ms. Jeanne Locher
|
| Vol #:
|
| 2
|
| |
|
|
| EC 160
|
| Ms. Carmen Harris
|
| Vol #:
|
| 2
|
| |
|
|
| EC 161
|
| Ms. Michele Wildeboer
|
| Vol #:
|
| 2
|
| |
|
|
| EC 162
|
| Greenpeace USA
|
| Vol #:
|
| 2
|
| |
|
|
| EC 163
|
| Mr. Erick Solberg
|
| Vol #:
|
| 2
|
| |
|
|
| EC 164
|
| Miss. Kirstin Emershaw
|
| Vol #:
|
| 2
|
| |
|
|
| EC 165
|
| Mr. Kenn Chandler
|
| Vol #:
|
| 2
|
| |
|
|
| EC 166
|
| Miss. Jessica Turner
|
| Vol #:
|
| 2
|
| |
|
|
| EC 167
|
| Ms. Gloria Feldscher
|
| Vol #:
|
| 2
|
| |
|
|
| EC 168
|
| Ms. Alexis Martin
|
| Vol #:
|
| 2
|
| |
|
|
| EC 169
|
| Ms. Misti Schmidt
|
| Vol #:
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| 2
|
| |
|
|
| EC 170
|
| Ms. Nicole Faby
|
| Vol #:
|
| 2
|
| |
|
|
| EC 171
|
| Ms. Rachel Seligman
|
| Vol #:
|
| 2
|
| |
|
|
| EC 172
|
| Mrs. Bonnie Knight
|
| Vol #:
|
| 2
|
| |
|
|
| EC 173
|
| Ms. Amanda Chawansky
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0403
|
| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
|
| |
|
|
| EC 2
|
| Mr. david lowe
|
| Vol #:
|
| 2
|
|
|
