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Dockets Management

Dockets Entered On January 23, 2007

 

Docket # Title
1976N-0052N OTC Nasal Decongestants
1978N-0065 Skin Bleaching Drug Products
1981N-0022 OTC Weight Control Drug Products for Human Use
2000D-1598 Voluntary Labeling for Bioengineered Foods
2000N-1396 Bioengineered Foods Consumed By Humans or Animals
2003N-0573 Draft Animal Cloning Risk Assessment
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2005P-0432 Ban all Non-medical Uses of the Antibacterial Agent Triclosan
2006N-0061 Charging for Investigational Drugs
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
2006P-0290 Risk Management Program for Fentanyl Products
2006P-0291 Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons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whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons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-0394 Revise the labeling requirements for eggs sold in the United States
2007P-0033 Amend the Nutrition Facts label on food products as it relates to trans fats.
1976N-0052N OTC Nasal Decongestants
LET 124 Nelson Mullins Riley & Scarborough, LLP Vol #: 86
1978N-0065 Skin Bleaching Drug Products
C 79 Women's Dermatologic Society Vol #: 20
1981N-0022 OTC Weight Control Drug Products for Human Use
LET 118 Nelson Mullins Riley & Scarborough, LLP Vol #: 98
2000D-1598 Voluntary Labeling for Bioengineered Foods
C 10016 L. Jacaruso Vol #: 580
2000N-1396 Bioengineered Foods Consumed By Humans or Animals
C 9619 L. Jacaruso Vol #: 415
2003N-0573 Draft Animal Cloning Risk Assessment
C 89 G and G Placas Vol #: 9
C 90 M. Dubrey Vol #: 9
C 91 S. Moore Vol #: 9
C 92 W. Cordain Vol #: 9
C 93 P. Budell Vol #: 9
C 94 A. Felix Vol #: 9
C 95 Integrative Medicine of Miami-Dade & Trinidad Vol #: 9
C 96 K. Cook Vol #: 9
C 97 S. Strauss Vol #: 9
C 98 J. Couch Vol #: 9
C 99 G. Philbrick Vol #: 9
C 100 S. Philbrick Vol #: 9
C 101 L. Brack Vol #: 9
C 102 S. Lesniak Vol #: 9
C 103 G and J Hoffmann Vol #: 9
C 104 L. Miller Vol #: 9
C 105 A. Hollier Vol #: 9
C 106 R. Wakefield Vol #: 9
C 107 G and W Hatcher Vol #: 9
C 108 J and B Geiger Vol #: 9
C 109 M. Vischer Vol #: 9
C 110 P. Mahnke Vol #: 9
C 111 V. Henderson Vol #: 9
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
C 667 Celiac Sprue Association Vol #: 23
C 668 National Foundation for Celiac Awareness (NFCA) Vol #: 23
CR 1 National Foundation for Celiac Awareness (NFCA) Vol #: 23
NPR 1 FDA Vol #: 23
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
C 23 Sanofi-aventis US, LLC Vol #: 3
C 24 Cleveland Clinic Foundation Vol #: 3
C 25 Prest-O-Sales & Service, Inc. Vol #: 3
C 26 PharMEDium Services Vol #: 3
C 27 Cryogas Vol #: 3
C 28 Compressed Gas Association (CGA) Vol #: 3
2005P-0432 Ban all Non-medical Uses of the Antibacterial Agent Triclosan
LET 2 FDA/CDEr to Beyond Pesticides Vol #: 1
2006N-0061 Charging for Investigational Drugs
C 2 National Organization for Rare Disorders, Inc. (NORD) Vol #: 1
2006N-0062 Expanded Access to Investigational Drugs for Treatment Use
C 4 National Organization for Rare Disorders, Inc. (NORD) Vol #: 1
2006P-0290 Risk Management Program for Fentanyl Products
LET 1 FDA/CDER to Mylan Laboratories Inc. Vol #: 1
2006P-0291 Determine whether Eloxatin (Oxaliplatin) has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons
LET 1 FDA/CDER to Sicor Pharmaceuticals, Inc. Vol #: 1
2006P-0298 To permit an ANDA Suitability for Eloxatin (Oxaliplatin for injection)
LET 1 FDA/CDER to AAC Consulting Group 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 1 FDA/CDER to Rothwell, Figg, Ernst & Manbeck, P.C. Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 24 Rose Acre Farms Vol #: 6
C 25 R. Downing Vol #: 6
C 26 CCF Brands Vol #: 6
2007P-0033 Amend the Nutrition Facts label on food products as it relates to trans fats.
ACK 1 DDM/FDA to Ellen M. Ashworth Vol #: 1
CP 1 Ellen M. Ashworth Vol #: 1

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