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Dockets Management
Dockets Entered On August 17, 2005
Table of Contents
Docket # Title
1981N-0033P Antigingivitis & Antiplaque-Related Claims
2000N-0504 Egg Safety Action Plan
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
2004N-0456 Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
2004P-0015 Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
2004P-0223 Whole Grain Descriptive Claims
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
2005D-0062 Draft Guidance FDAs Drug Watch for Emerging Drug Safety
2005D-0202 Guidance for Industry on Bar Code Label Requirements; Questions and Answers
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
2005P-0076 OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
2005P-0116 To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
2005P-0242 ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
2005P-0282 Require Health Messages on Soft Drinks
1981N-0033P Antigingivitis & Antiplaque-Related Claims
C 27 Colgate-Palmolive Company Vol #: 92
2000N-0504 Egg Safety Action Plan
EMC 1935 C. Santos Vol #: 31
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 14488 H. Klaus, MD Vol #: 342
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 501 Mission Possible International Vol #: 8
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 901 F. Putter Vol #: 11
EMC 902 M. Crnolatas Vol #: 11
EMC 903 Y. Yi Vol #: 11
EMC 904 No Signature Vol #: 11
EMC 905 D. Hines Vol #: 11
EMC 906 J. Thomas Vol #: 11
EMC 907 G. Barros Vol #: 11
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
EMC 1166 T. Reeder Vol #: 29
EMC 1167 M. Farbstein Vol #: 29
2004N-0456 Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
EMC 790 J. Miller Vol #: 9
2004P-0015 Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
PDN 1 HFD-001 to Buc & Beardsley Vol #: 1
2004P-0223 Whole Grain Descriptive Claims
C 26 Quaker Oats Company (Quaker) Vol #: 5
2004Q-0151 Qualified Health Claim (QHC): soy protein and cancer
EMC 348 The Weston A. Price Foundation Vol #: 9
2005D-0062 Draft Guidance FDAs Drug Watch for Emerging Drug Safety
EMC 2 Consumer Healthcare Products Association (CHPA) Vol #: 2
EMC 3 Pfizer, Inc. Vol #: 2
EMC 4 Biotechnology Industry Organization (BIO) Vol #: 2
2005D-0202 Guidance for Industry on Bar Code Label Requirements; Questions and Answers
C 5 Roxane Laboratories, Inc. Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
C 6 M. Hoffman Vol #: 1
C 7 E. Findley Vol #: 1
C 8 G. F. Cresswell, M.D. Vol #: 1
C 9 C. B. Cresswell Vol #: 1
2005P-0076 OxyContin and Paladone removal from market and label changes limiting indications to severe chronic pain
LET 1 HFD-005 to Kirk Van Rooyan and Barbara Van Rooyan Vol #: 1
2005P-0116 To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
C 2 International Academy of Compounding Pharmacists (IACP) Vol #: 2
2005P-0242 ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
AMD 1 Samson Medical Technologies, LLC Vol #: 1
2005P-0282 Require Health Messages on Soft Drinks
C 4 R. Boorstein Vol #: 1
C 5 K. Brunnier Vol #: 1
C 6 L. Klingeman Vol #: 1
C 7 A. Brandenburg Vol #: 1
C 8 F. Miller Vol #: 1
C 9 M. Trice Vol #: 1
C 10 Form Letters Vol #: 3

Page created on August 26, 2005 kk

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