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| Dockets Entered
On October 27, 2006
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| Docket #
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| Title
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| 1975N-0183
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| OTC topical antimicrobial products
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000V-1576
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| AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| 2004P-0290
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| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005P-0462
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| Initiate a Transfer of Regulatory and Classification Responsibilities over Mercury Amalgam
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| 2005P-0465
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| Withdraw Draft Regulation on Mercury Amalgam
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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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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 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-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| 2006P-0438
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| ANDA for Betamethasone Valerate Foam (non-aerosol), 0.12%
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| 2006V-0440
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| Laser Light Show
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| 1975N-0183
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| OTC topical antimicrobial products
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| SUP 53
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| SWAN Chemical Inc.
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| Vol #:
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| 175
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| C 143
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| Priority Pharmaceuticals, Inc.
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| Vol #:
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| 8
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| C 144
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| Richmark Medical Supply
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| Vol #:
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| 8
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| C 145
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| Bell Medical Services, Inc.
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| Vol #:
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| 8
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| C 146
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| Sterling Medical Products
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| Vol #:
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| 8
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| C 136
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| Priority Pharmaceuticals, Inc.
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| Vol #:
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| 10
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| C 137
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| Richmark Medical Supply
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| Vol #:
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| 10
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| C 138
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| Bell Medical Services, Inc.
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| Vol #:
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| 10
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| C 139
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| Sterling Medical Products, Inc.
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| Vol #:
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| 10
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| C 140
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| Atlantic Biologicals Corporation
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| Vol #:
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| 10
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7538
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| W. Bain
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| Vol #:
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| 319
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| 2000V-1576
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| AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
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| VRA 7
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| HFZ-200 to Insight Technology Incorporated
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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 1395
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| R. Damerow
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| Vol #:
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| 259
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| BKG 1
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| Background Material
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| 2
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| GDL 2
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| Guidance
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| 1
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| 2004P-0290
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| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
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| SUP 4
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| LET 13
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| AstraZeneca Pharmaceuticals, LP
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| Vol #:
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| 2
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| 2005P-0462
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| Initiate a Transfer of Regulatory and Classification Responsibilities over Mercury Amalgam
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| PAV 1
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| FDA/CDRH to Consumers for Dental Choice
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| 1
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| 2005P-0465
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| Withdraw Draft Regulation on Mercury Amalgam
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| PAV 1
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| FDA/CDRH to Consumers for Dental Choice
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| Vol #:
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| 1
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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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| EC 45
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| AstraZeneca LP
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| Vol #:
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| 2
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| EC 2
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| Puracyp, Inc.
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| Vol #:
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| 1
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| EC 3
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| Pharmacists For Life International
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| Vol #:
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| 1
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| EC 87
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| Dr. Roberta Cann
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| Vol #:
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| 3
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| EC 88
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| Mrs. Cathy Maestas
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| Vol #:
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| 3
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| EC 89
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| Ms. Sandra Flood
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| Vol #:
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| 3
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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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| C 10
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| B. Kwasnik
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| Vol #:
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| 6
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| C 11
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| R. Downing
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| Vol #:
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| 6
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| C 12
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| No Submitter
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| Vol #:
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| 6
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| C 13
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| S. & H. Wyck
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| Vol #:
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| 6
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| C 14
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| S. Jotoku
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| Vol #:
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| 6
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| C 15
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| D. Lytle
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| Vol #:
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| 6
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| EC 360
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| Miss. rebecca keesling
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| Vol #:
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| 2
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| EC 361
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| Ms. Kala Stanley
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| Vol #:
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| 2
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| EC 362
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| Ms. Ann Katcef
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| Vol #:
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| 2
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| EC 363
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| Mr. Dave Norman
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| Vol #:
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| 2
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| EC 364
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| Mrs. Melissa Hapney
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| Vol #:
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| 2
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0438
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| ANDA for Betamethasone Valerate Foam (non-aerosol), 0.12%
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| ACK 1
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| FDA/DDM to Olsson, Frank and Weeda, P.C.
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| Vol #:
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| 1
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| CP 1
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| Olsson, Frank and Weeda, P.C.
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| Vol #:
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| 1
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| 2006V-0440
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| Laser Light Show
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| ACK 1
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| FDA ?DDM to Hyperfomance Audio Productions
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| Vol #:
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| 1
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| VAR 1
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| Hyperfomance Audio Productions
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| Vol #:
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| 1
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