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Dockets Management

Dockets Entered On November 27, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2001P-0470 Establish Appropriate Approval Standards for Generic Clonidine Transdermal Products
2004N-0217 Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
2005D-0490 Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2)
2005P-0189 Nutrient content claims for ALA and DHA omega-3 fatty acids
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
2006P-0137 Nutrient Content Claim for EPA and DHA omega-3 fatty acids
2006P-0210 Amend regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically
2006P-0291 Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons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whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons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
2007D-0310 Companion to Guidance for Industry on Pharmacogenomic Data
2007N-0262 Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
2007N-0382 Ramipril Capsules and 180-day generic drug exclusivity
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Drug Eloxatin (oxaliplatin for injection) Lyophilized Powder for Infusion, 50 and 100 mg Vials Has Been Voluntarily Withdrawn From Sale for Safety or Efficacy Rea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-0178 Take action to subject certain cardiac surgery devices to premarket notification (510(k) requirements
1978N-0038 Sunscreen Drug Products
C 677 Venable LLP Vol #: 164
C 678 The Assembly State of New York Albany Vol #: 164
C 679 Crown Laboratories, Inc. Vol #: 164
C 680 Crown Laboratories, Inc. Vol #: 164
C 681 Jack Lingo, Inc. Realtor Vol #: 164
C 682 Office of Insurance and Safety Fire commissioner Vol #: 164
C 683 Life Producs, Inc. Vol #: 164
C 684 Crown Laboratories, Inc. Vol #: 164
C 685 Swiss American Vol #: 164
C 686 Vera Wright Vol #: 164
C 687 M. Kingston Vol #: 164
C 688 Swiss American Vol #: 164
C 689 M. G. Greenberg, Ph. D. Vol #: 164
C 690 BASF The Chemical Company Vol #: 164
C 691 International Center for Technology Assessmnt Vol #: 165
C 692 Swiss American Vol #: 170
C 693 Dr. G. O. Telford Vol #: 170
EC 2685 German Society of Cosmetic Chemists - DGK Vol #: 164
EC 2686 German Society of Cosmetic Chemists - DGK Vol #: 164
EC 2687 German Society of Cosmetic Chemists - DGK Vol #: 164
EC 2688 Merck KGaA, Germany Vol #: 164
EC 2689 Venable, LLP Vol #: 164
EC 2690 Mrs. Laura Scolari Vol #: 164
EC 2691 American Association for Justice Vol #: 164
EC 2692 Ciba Corporation Vol #: 164
EC 2693 Merz Pharmaceuticals Vol #: 164
EC 2694 Northwestern University Vol #: 164
EC 2695 Citizens for Sun Protection Vol #: 164
EC 2696 Croda Inc Vol #: 164
EC 2697 Dr. John Dowdy Vol #: 164
EC 2698 Dr. John Dowdy Vol #: 164
EC 2699 Ms. Jennifer Sloan Vol #: 164
EC 2700 Rapid Precision Testing Laboratories Vol #: 164
EC 2701 Mr. Jonathan Keim Vol #: 164
EC 2702 Rapid Precision Testing Laboratories Vol #: 164
EC 2703 Rapid Precision Testing Laboratories Vol #: 164
EC 2704 Ms. Maxine Kingston Vol #: 164
EC 2705 Miss. Jessica Naden Vol #: 164
EC 2706 Ms. Honor Banvard Vol #: 164
EC 2707 Solar Light Company, Inc. Vol #: 164
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 21078 New Chapter, Inc. Vol #: 182
LET 21079 Planetary Herbals Vol #: 182
LET 21080 Planetary Herbals Vol #: 182
LET 21081 Planetary Herbals Vol #: 182
LET 21082 CCA Industries, Inc. Vol #: 182
LET 21083 Herbalist & Alchemist, Inc. Vol #: 182
LET 21084 Herbalist & Alchemist, Inc. Vol #: 182
LET 21085 Herbalist & Alchemist, Inc. Vol #: 182
LET 21086 ZeaVision, LLC Vol #: 182
LET 21087 Vita-Herbs, Inc. Vol #: 182
LET 21088 Vita-Herbs, Inc. Vol #: 182
LET 21089 Babener & Associates Vol #: 182
LET 21090 Cyanotech Vol #: 182
LET 21091 Cyanotech Vol #: 182
LET 21092 Enzymatic Therapy Vol #: 182
LET 21093 Enzymatic Therapy Vol #: 182
LET 21094 Enzymatic Therapy Vol #: 182
LET 21095 Enzymatic Therapy Vol #: 182
2001P-0470 Establish Appropriate Approval Standards for Generic Clonidine Transdermal Products
BKG 1 FDA Advisory Committee Vol #: 2
2004N-0217 Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids)
NPR 1 FDA Vol #: 3
REF 1 Reference Vol #: 4
2005D-0490 Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004; Guidance (Edition 2)
ANS 14 FDA/CFSA to Taro Dram Inc. Vol #: 1
ELET 14 Taro Dream Inc. Vol #: 1
2005P-0189 Nutrient content claims for ALA and DHA omega-3 fatty acids
NPR 1 FDA Vol #: 2
REF 1 Reference Vol #: 3
2006N-0168 Food Labeling: Reference Daily Intakes & Daily Reference Values
C 1 The Association for Dressings & Sauces Vol #: 1
C 2 The Vinegar Institute Vol #: 1
2006P-0137 Nutrient Content Claim for EPA and DHA omega-3 fatty acids
NPR 1 FDA Vol #: 1
REF 1 Reference Vol #: 2
2006P-0210 Amend regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically
C 3 International Center for Technology Assessment Vol #: 5
2006P-0291 Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
N 1 FDA Vol #: 1
2006P-0298 To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
N 1 FDA 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
N 1 FDA Vol #: 1
2006P-0309 ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
N 1 FDA Vol #: 1
2007D-0310 Companion to Guidance for Industry on Pharmacogenomic Data
EC 3 sanofi-aventis Vol #: 1
EC 4 Merck Serono International S.A. Vol #: 1
EC 5 Abbott Vol #: 1
2007N-0262 Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
C 7 Susan Tumbarello Vol #: 1
2007N-0356 BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
C 5 American Society For Reproductive Medicine Vol #: 2
NCR 1 FDA Vol #: 2
2007N-0382 Ramipril Capsules and 180-day generic drug exclusivity
C 8 FOLEY & LARDNER LLP Vol #: 1
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
N 1 FDA Vol #: 1
2007P-0178 Take action to subject certain cardiac surgery devices to premarket notification (510(k) requirements
LET 1 Mark Raza Vol #: 1

Page created on November 27, 2007 ue

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