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Dockets Management
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| Dockets Entered On July 19, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003D-0001
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| Nonclinical Safety Evaluation of Pediatric Drug Products
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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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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| 2006D-0150
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| Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Sp
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| 2006FL-0287
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| Food Allergen Labeling (FALN): Lyophilized Probiotic Cultures
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| 2006N-0180
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience with Approved New Animal Drugs
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0195
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its original formulation of Zosyn (piperacillin and tazobactam) for reasons unrelated to safety and efficacy and to allow companies to file Abbr
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| 2006P-0249
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| Refain from approving all abbreviated applications for generic enrofloxacin that purport to copy Bayer's Baytril 100 Injectable Solution
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| 2006P-0287
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| determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2006P-0288
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| permit an ANDA suitability for alprazolam
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| 2006V-0289
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17973
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| Sunrider International
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| Vol #:
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| 165
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| LET 17974
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| Sunrider International
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| Vol #:
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| 165
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| LET 17975
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| Sunrider International
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| Vol #:
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| 165
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| LET 17976
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| Michael's Natruopathic Programs
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| Vol #:
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| 165
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| LET 17977
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| Michael's Naturopathic Programs
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| Vol #:
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| 165
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| LET 17978
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| Michael's Naturopathic Programs
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| Vol #:
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| 165
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| LET 17979
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| Michael's Naturopathic Programs
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| Vol #:
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| 165
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| LET 17980
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| Nikken Inc
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| Vol #:
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| 165
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| 2003D-0001
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| Nonclinical Safety Evaluation of Pediatric Drug Products
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| EC 10
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| Miss. Rachel Kent
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| Vol #:
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| 1
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| 2005D-0122
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| Guidance for Industry on Exploratory IND Studies
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| EC 19
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| Mr. David Lowe
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| Vol #:
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| 2
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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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| C 15859
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| Westcore Properties, LLC
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| Vol #:
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| 175
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| C 15860
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| P. Micheal
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| Vol #:
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| 175
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| EC 628
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| Mrs. Julia Craig
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| Vol #:
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| 3
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| EC 629
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| Independent Researcher
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| Vol #:
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| 3
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| 2006P-0195
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its original formulation of Zosyn (piperacillin and tazobactam) for reasons unrelated to safety and efficacy and to allow companies to file Abbr
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0249
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| Refain from approving all abbreviated applications for generic enrofloxacin that purport to copy Bayer's Baytril 100 Injectable Solution
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| EC 3
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0287
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| determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
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| ACK 1
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| FDA/ DDM to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP 1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2006P-0288
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| permit an ANDA suitability for alprazolam
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| ACK 1
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| FDA/ DDM to Beckloff Associates
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| Vol #:
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| 1
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| CP 1
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| Beckloff Associates
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| Vol #:
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| 1
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| 2006V-0289
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| Laser Light Show
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| ACK 1
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| FDA/ DDM to Bliss Nashville LLC
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| Vol #:
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| 1
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| VAR 1
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| Bliss Nashville LLC
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| Vol #:
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| 1
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