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| Dockets Entered
On September 12, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1998C-0431
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| Synthetic Iron Oxide
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/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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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004P-0265
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| Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different than zucapsaicin
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| 2004P-0379
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| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| 2005D-0223
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| Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability
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| 2005D-0288
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| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
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| 2005D-0312
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| Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2005N-0218
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| FDA Vision 2006: A Conversation with the American Public
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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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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005P-0104
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| Determine whether Peptavlon (pentagastrin) was voluntarily withdrawn from sale for reasons other than safety or effectiveness
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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| 2005V-0333
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| Projector for a Laser Light Show
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| 2005V-0365
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| Laser Light Show
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
289
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| Naturaleaf Inc
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| Vol #:
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| 227
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| RPT
290
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| Aminocare Products LP
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| Vol #:
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| 214
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| 1998C-0431
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| Synthetic Iron Oxide
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| EMC 2
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| Gatewood Organization LLC
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| Vol #:
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| 1
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| 1999F-4372
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| National Fisheries Institute and the Louisiana Dep of Agricu
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| OB 1
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| G Atwood
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| Vol #:
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| 8
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 609
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| R C Cordero
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| Vol #:
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| 24
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1280
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| K Jobalia
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| Vol #:
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| 6
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| EMC 1281
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| P Rose
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| Vol #:
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| 6
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| EMC 1282
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| S Charlton
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| Vol #:
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| 6
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| EMC 1283
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| Sekora's
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| Vol #:
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| 6
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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 1108
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| J Collum
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| Vol #:
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| 11
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| EMC 1109
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| R Lyles
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| Vol #:
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| 11
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| EMC 1110
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| J Drake
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| Vol #:
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| 11
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CFF 1
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| Juan C. Carrai
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| Vol #:
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| 2
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| CFF 2
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| Juan C. Carrai
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| Vol #:
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| 2
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| CS 14
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| HFA-305
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| Vol #:
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| 2
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| OR 13
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| HF-3 to Ecumned Health Group, Amador Reyes, Juan C. Carrai, Richard W. Stone & Erlinda E. Enri
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| Vol #:
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| 2
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| 2004P-0265
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| Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different than zucapsaicin
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| PDN
1
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| HF-22 to Winston Laboratories Inc
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| Vol #:
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| 2
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| 2004P-0379
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| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
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| ANS
1
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| HFD-7 to AAC Consulting Group
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| Vol #:
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| 1
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| 2005D-0174
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| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
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| C
7
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| Cardinal Health
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| Vol #:
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| 1
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| 2005D-0223
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| Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability
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| C
1
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| Bracco Diagnostics Inc
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| Vol #:
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| 1
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| 2005D-0288
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| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
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| EC 1
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| Mr. Stephen Hall
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| Vol #:
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| 1
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| EC
2
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| Teva Pharmaceutical Industries Ltd.
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| Vol #:
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| 1
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| 2005D-0312
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| Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
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| C 2
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| B Jennings
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| Vol #:
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| 1
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| EC 14
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| Ms. Elizabeth Graham
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| Vol #:
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| 1
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| 2005N-0218
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| FDA Vision 2006: A Conversation with the American Public
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| EC
1
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| American College of Neuropsychopharmacology
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| Vol #:
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| 1
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