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Dockets Management

Dockets Entered On November 30, 2007
Docket # Title
1976N-0052T OTC ANTITUSSIVES
1978N-0038 Sunscreen Drug Products
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2005D-0019 Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
2005N-0017 Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
2005P-0450 Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
2006D-0480 Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
2006P-0291 Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
2006P-0298 To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
2006P-0299 Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
2006P-0309 ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
2006P-0508 Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
2007D-0212 Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
2007N-0323 Agency Information Collection Activities: Proposed Collection; Comment Request;
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
2007P-0062 Determine Whether a Previously Listed Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy Rea
2007P-0297 Request to reconsider the failure to approve Provenge
2007P-0438 Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
2007P-0465 Review Labeling and Bioequivalence Standards for Felodipine Extended-Release Tablets to Incorporate Safety Information and Ensure Equivalent Product Safety and Effectiveness
2007P-0466 Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate
1976N-0052T OTC ANTITUSSIVES
NFR 3 FDA Vol #: 8
1978N-0038 Sunscreen Drug Products
C 694 L'Oreal, USA Vol #: 171
EC 2708 Mrs. Rebecca Wilson Vol #: 170
EC 2709 Ms. Karen Walsh Vol #: 170
EREG 13 G. Kimbrell Vol #: 170
EREG 14 K. Markey Vol #: 170
EREG 15 J. Mayo Vol #: 170
EREG 16 B. Sachau Vol #: 170
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 21141 NBTY, Inc. Vol #: 182
LET 21142 NBTY, Inc. Vol #: 182
LET 21143 NBTY Vol #: 182
LET 21144 NBTY Vol #: 182
LET 21145 NBTY Vol #: 182
LET 21146 NBTY Vol #: 182
LET 21147 NBTY Vol #: 182
LET 21148 NBTY Vol #: 182
LET 21149 NBTY Vol #: 182
LET 21150 NBTY Vol #: 182
LET 21151 NBTY Vol #: 182
LET 21152 NBTY Vol #: 182
LET 21153 NBTY Vol #: 182
LET 21154 NBTY Vol #: 182
LET 21155 NBTY Vol #: 182
LET 21156 NBTY, Inc. Vol #: 182
LET 21157 NBTY, Inc. Vol #: 182
LET 21158 NBTY, Inc. Vol #: 182
LET 21159 NBTY, Inc. Vol #: 182
LET 21160 NBTY, Inc. Vol #: 182
LET 21161 NBTY, Inc. Vol #: 182
LET 21162 NBTY, Inc. Vol #: 182
LET 21163 NBTY, Inc. Vol #: 182
LET 21164 NBTY, Inc. Vol #: 182
LET 21165 NBTY, Inc. Vol #: 182
LET 21166 NBTY, Inc. Vol #: 182
LET 21167 NBTY, Inc. Vol #: 182
LET 21168 NBTY, Inc. Vol #: 182
LET 21169 NBTY, Inc. Vol #: 182
LET 21170 NBTY, Inc. Vol #: 182
LET 21171 NBTY, Inc. Vol #: 182
LET 21172 NBTY, Inc. Vol #: 182
LET 21173 NBTY, Inc. Vol #: 182
LET 21174 Metagencies Vol #: 182
LET 21175 Perrigo Company of South Carolina Vol #: 182
LET 21176 Perrigo Company of South Carolina Vol #: 182
LET 21177 Perrigo Company of South Carolina Vol #: 182
LET 21178 Perrigo Company of South Carolina Vol #: 182
LET 21179 Perrigo Company of South Carolina Vol #: 182
LET 21180 Perrigo Company of South Carolina Vol #: 182
LET 21181 Perrigo Company of South Carolina Vol #: 182
LET 21182 Perrigo Company of South Carolina Vol #: 182
LET 21183 Perrigo Company of South Carolina Vol #: 182
2005D-0019 Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Pri
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
REF 1 References Vol #: 1
2005N-0017 Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
NFR 1 FDA Vol #: 1
2005P-0450 Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
EC 9 Dr. Thomas Stout Vol #: 1
EC 10 Concerned Father/Citizen Vol #: 1
EC 11 N/A Vol #: 1
EC 12 Cambridge Food Control Ltd Vol #: 1
EC 13 Mr. Daniel Karlin Vol #: 1
2006D-0480 Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration
C 1436 National Solutions Foundation Vol #: 61
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
EREG 3 J. Cybulski Vol #: 1
2006P-0291 Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
LET 2 Elizabeth Sadove Vol #: 1
2006P-0298 To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
LET 2 Janet Woodcock Vol #: 1
2006P-0299 Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
LET 2 Elizabeth Sadove Vol #: 1
2006P-0309 ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
LET 2 Elizabeth Sadove Vol #: 1
2006P-0508 Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
C 2 Charles Weber Vol #: 1
2007D-0212 Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
C 4 D. Jaffe Vol #: 1
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
NEC 1 FDA Vol #: 1
2007N-0323 Agency Information Collection Activities: Proposed Collection; Comment Request;
N 2 FDA Vol #: 1
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
EC 109 Cooper Research, Inc. Vol #: 2
EC 110 Dr. William Cartmill Vol #: 2
EC 111 American Academy of Family Physicians Vol #: 2
LST 1 Agenda of November 14, 2007 Public Meeting Vol #: 3
TS 1 American Society of Health-System Pharmacists Vol #: 3
TS 2 American College of Clinical Pharmacy Vol #: 3
TS 3 American Pharmacists Association Vol #: 3
TS 4 University of California San Francisco School of Phamacy Vol #: 3
TS 5 St. John's University Vol #: 3
TS 6 Samford University Vol #: 3
TS 7 UCLA Vol #: 3
TS 8 Consumer Healthcare Products Association Vol #: 3
TS 9 Health Canada Vol #: 3
TS 10 Mount Sinai School of Medicine Vol #: 3
TS 11 National Alliance of State Pharmacy Associations Vol #: 3
TS 12 University of Pittsburgh Vol #: 3
TS 13 McNeil Consumer Healthcare Vol #: 3
TS 14 J. Richard Crout, M.D. Vol #: 3
TS 15 Mann Healthcare Ltd Vol #: 3
TS 16 Francesco International Vol #: 3
TS 17 GlaxoSmithKline Vol #: 3
2007P-0062 Determine Whether a Previously Listed Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy Rea
LET 1 Elizabeth Sadove Vol #: 1
2007P-0297 Request to reconsider the failure to approve Provenge
EC 145 Mr. Bill Moore Vol #: 1
2007P-0438 Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
EC 9 Ms. Lois Davidson Vol #: 1
EC 10 Founder of the MCS Beacon of Hope Foundation Vol #: 1
EC 11 Co-Founder of the MCS Beacon of Hope Foundation Vol #: 1
EC 12 MCS Beacon of Hope Foundation Vol #: 1
2007P-0465 Review Labeling and Bioequivalence Standards for Felodipine Extended-Release Tablets to Incorporate Safety Information and Ensure Equivalent Product Safety and Effectiveness
ACK 1 FDA to United Research Laboratories, Inc. Mutual Pharmaceutical Company, Inc. Vol #: 1
CP 1 United Research Laboratories, Inc. Mutual Pharmaceutical Company, Inc. Vol #: 1
2007P-0466 Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate
ACK 1 FDA/DDM to Medicure Pharma Vol #: 1
CP 1 Medicure Pharma Vol #: 1

Page created on December 3, 2007 ue

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