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Dockets Management
Dockets Entered On August 9, 2005
Table of Contents
Docket # Title
1977N-0231 PENICILLIN IN ANIMAL FEEDS
1998P-0203 Eliminate Forced Molting of Laying Birds
2001C-0486 Tomato lycopene extract to color foods generally
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
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
2004H-0322 Civil Money Penalty Re: Ecumed Health Group, Inc.
2005D-0062 Draft Guidance FDAs Drug Watch for Emerging Drug Safety
2005D-0155 Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
2005D-0202 Guidance for Industry on Bar Code Label Requirements; Questions and Answers
2005D-0203 Guidance for Industry on Safety Testing of Drug Metabolites
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
2005P-0315 ANDA for Ursodiol Oral Suspension, 20 mg/mL
2005V-0313 Laser Light Show
2005V-0314 Laser Light Show
2005V-0316 Laser Light Show
1977N-0231 PENICILLIN IN ANIMAL FEEDS
ANS 624 HFL-1 to Hon. Lee H. Hamilton Vol #: 27
1998P-0203 Eliminate Forced Molting of Laying Birds
EMC 3 T. Goodrich Vol #: 47
2001C-0486 Tomato lycopene extract to color foods generally
EMC 1 D. Salmon Vol #: 1
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 14486 R. Justin Vol #: 342
EMC 14487 J. Allen Vol #: 342
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1276 B. Couser Vol #: 6
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 499 Calorie Control Council Vol #: 8
EMC 500 Calorie Control Council Vol #: 8
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 896 C. Rebert Vol #: 11
EMC 897 A. Bibo Vol #: 11
EMC 898 A. Heimerl Vol #: 11
EMC 899 E. Burton Vol #: 11
EMC 900 C. Quinn Vol #: 11
2004H-0322 Civil Money Penalty Re: Ecumed Health Group, Inc.
MO 10 Ecumed Health Group and Amador Reyes, Juan C. Carrai, Richard W. Stone M.D., & Erlinda B. Enri Vol #: 2
2005D-0062 Draft Guidance FDAs Drug Watch for Emerging Drug Safety
C 13 Pharmaceutical research and Manufacturers of America (PhRMA) Vol #: 1
C 14 Pfizer, Inc. Vol #: 1
EC 7 Academy of Managed Care Pharmacy Vol #: 1
EC 8 Pfizer Inc Vol #: 1
EC 9 Pfizer Inc Vol #: 1
EC 10 Pfizer Inc Vol #: 1
EC 11 National Consumers League Vol #: 1
EC 12 Pfizer Inc Vol #: 1
EC 13 Pfizer Inc Vol #: 1
EC 14 Pfizer Inc Vol #: 1
EC 15 Pfizer Inc Vol #: 1
EC 16 American Pharmacists Association Vol #: 1
EC 17 Johnson & Johnson Vol #: 1
EC 18 Consumer Healthcare Products Association Vol #: 1
EC 19 American College of Obstetricians & Gynecologists Vol #: 1
EC 20 Pharm Res & Mfrs of America Vol #: 1
EC 21 American Society of Health-System Pharmacists Vol #: 1
2005D-0155 Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
EMC 1 Merck & Co., Inc. Vol #: 1
2005D-0202 Guidance for Industry on Bar Code Label Requirements; Questions and Answers
C 4 Wyeth Pharmaceuticals Vol #: 1
2005D-0203 Guidance for Industry on Safety Testing of Drug Metabolites
EMC 3 Japan Pharmaceutical Manufacturers Association (JPMA) Vol #: 1
EMC 4 Merck & Co., Inc. Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
EMC 1 S. Segal Vol #: 1
EMC 2 M. Beaubien CRS, GRI Vol #: 1
EMC 3 L. Johnson Vol #: 1
EMC 4 S. Dyal Vol #: 1
EMC 5 K. Schaffer Vol #: 1
EMC 6 G. Baldan Vol #: 1
EMC 7 No signature Vol #: 1
EMC 8 No signature Vol #: 1
2005P-0315 ANDA for Ursodiol Oral Suspension, 20 mg/mL
ACK 1 HFA-305 to CanReg, Inc. Vol #: 1
CP 1
Tab 1, Tab 2
CanReg, Inc. Vol #: 1
2005V-0313 Laser Light Show
ACK 1 HFA-305 to Oxygen Sound LLC, Vol #: 1
VAR 1 Oxygen Sound LLC, Vol #: 1
2005V-0314 Laser Light Show
ACK 1 HFA-305 to Anthony Fransen Productions Vol #: 1
VAR 1 Anthony Fransen Productions Vol #: 1
2005V-0316 Laser Light Show
ACK 1 HFA-305 to Beau Rivage Resort Vol #: 1
VAR 1 Beau Rivage Resort Vol #: 1

Page created on August 19, 2005 dp

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