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| Dockets Entered
On April 20, 2006
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| Docket #
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| Title
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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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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| 2005P-0242
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| ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
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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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| 2005P-0429
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| re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the Controlled Substances Act of 1970 as amended
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| 2006D-0044
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| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| 2006N-0152
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| Preparation for International Conference on Harmonization Meetings in Yokohama, Japan; Public Meeting
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| 2006P-0074
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| Determine whether Doxycycline Tablets, 75 mg (ANDA 65-070), held by Par Pharmaceuticals has been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2006P-0167
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| ANDA Suitability for Oxycodone and Acetaminophen drug product in an orally disintigrating form
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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 1319
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| G. Sheldon
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| Vol #:
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| 6
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| EMC 1320
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| G. Bakos
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| Vol #:
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| 6
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 636
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 637
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| Mission Possible International
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| Vol #:
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| 9
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| EMC 638
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| Mission Possible International
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| Vol #:
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| 9
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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 1279
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| N. Morrison
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| Vol #:
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| 12
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| EMC 1280
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| J. Henderson
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| Vol #:
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| 12
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| EMC 1
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| Abbott Laboratories (Abbott)
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| Vol #:
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| 1
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| 2005D-0219
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| Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
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| EC 7
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| Ms. Summer Boyd-Jones
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| Vol #:
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| 0
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| EC 8
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| Mrs. Patricia Glinn
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| Vol #:
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| 0
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| C 6544
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| J. Robinson
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| Vol #:
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| 90
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| 2005P-0429
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| re-evaluate the prescribing info/package insert for new tramadol and tramadol as schedule III drugs under the Controlled Substances Act of 1970 as amended
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| LET 1
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| FDA/CDER to Cinergen
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| 2
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| 2005P-0430
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| Requests that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act.
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| LET 1
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| FDA/CDER to Gregory E. Skipper. M. D.
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| Vol #:
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| 1
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| 2006D-0044
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| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
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| C 17
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| CompleWare Corporation
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| 3
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| C 18
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| California Department of Health Services
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| Vol #:
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| 1
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| 2006N-0152
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| Preparation for International Conference on Harmonization Meetings in Yokohama, Japan; Public Meeting
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2006P-0074
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| Determine whether Doxycycline Tablets, 75 mg (ANDA 65-070), held by Par Pharmaceuticals has been voluntarily withdrawn from sale for safety or efficacy reasons
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| WDL 1
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| 2006P-0167
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| ANDA Suitability for Oxycodone and Acetaminophen drug product in an orally disintigrating form
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| ACK 1
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| HFA-305 to Arnall Golden Gregory LLP
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| Vol #:
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| 1
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| ACK 2
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| HFA-305 to Arnall Golden Gregory LLP
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| Vol #:
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| 1
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| CP 1
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| Arnall Golden Gregory LLP
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| Vol #:
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| 1
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| CP 2
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| Arnall Golden Gregory LLP
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| Vol #:
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| 1
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