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DOCKETS ENTERED on May 7, 2003

Docket Number - Title  

     

91N-384H  Nutrient Content Claims, Definition of Term:  Healthy

93N-0349  Debarment of Satish R. Shah; Notice of Opportunity for Hear

95N-0309  CGMPs for the Production of Infant Formula

97S-0162  30-Day Structure Function Claim Notification Letters Dietary

98P-0610  Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

99F-4372  National Fisheries Institute and the Louisiana Dep of Agricu

00N-1571  Enrofloxacin for Poultry: Opportunity for Hearing

01P-0470  Establish Appropriate Approval Standards for Generic Clonidi

02N-0528  Risk Management Workshop, April 9-11, 2003 [PDUFA III]

02N-0534  Medical Device User Fee and Modernization Act of 2002

03D-0163  Blood Product Safety in Cases of Suspected SARS,Severe Acute

03P-0107  Synthroid (levothyroxine sodium) Tablets (NDA 21-402)

03P-0113  Levoxyl (levothyroxine sodium) tablets (NDA #21-301)

 

77P-0403  Model 2001 light show laser projector

VRA 13      HFZ-300 to Laser Production Network       Vol#: 1

91N-384H  Nutrient Content Claims, Definition of Term:  Healthy

C   125     Quest International, Flavors & Food Ingr  Vol#: 13

 

EXT 4       Salt Institute                            Vol#: 13

 

NEC 4                                                 Vol#: 13

93N-0349  Debarment of Satish R. Shah; Notice of Opportunity for Hear

LET 16      HFD-7 to Satish R. Shah                   Vol#: 1

 

95N-0304  Ephedrine Alkaloids: Reports of Adverse Events; Availability

EMC 763     Felix Bronstein                           Vol#: 346

95N-0309  CGMPs for the Production of Infant Formula

EXT 2       International Formula Council (IFC)       Vol#: 7

 

96N-0417  CGMP in Mfg. Packing or Holding Dietary Supplements

EMC 19      Erik Thor                                 Vol#: 7

 

96P-0500  Amend "Healthy" Definition re: Sodium Levels

C   35      Quest International, Flavors & Food Ingr  Vol#: 10

 

EXT 4       Salt Institute                            Vol#: 10

 

NEC 3                                                 Vol#: 10

97S-0162  30-Day Structure Function Claim Notification Letters Dietary

LET 10413   Basic Research, L.L.C.                    Vol#: 78

 

LET 10414   Basic Research., L.L.C.                   Vol#: 78

 

LET 10415   Basic Research, L.L.C.                    Vol#: 78

 

LET 10416   Basic Research, L.L.C.                    Vol#: 78

 

LET 10417   Solgar Vitamin and Herb                   Vol#: 78

 

LET 10418   Natural Organics Inc.                     Vol#: 78

 

LET 10419   Source Naturals                           Vol#: 78

 

LET 10420   PhytoPharmica Natural Medicines           Vol#: 78

 

LET 10421   Natural Organics Inc.                     Vol#: 78

 

LET 10422   Natural Organics Inc.                     Vol#: 78

 

LET 10423   Natural Organics Inc.                     Vol#: 78

 

LET 10424   Natural Organics inc.                     Vol#: 79

 

LET 10425   Natural Organics Inc.                     Vol#: 79

 

LET 10426   Natural Organics Inc.                     Vol#: 79

 

LET 10427   Natural Organics Inc.                     Vol#: 79

 

LET 10428   Natural Organics Inc.                     Vol#: 79

 

LET 10429   Natural Organics Inc.                     Vol#: 79

 

LET 10430   Natural Organics Inc.                     Vol#: 79

 

LET 10431   Natural Organics Inc.                     Vol#: 79

 

LET 10432   Natural Organics Inc.                     Vol#: 79

 

LET 10433   Natural Organics Inc.                     Vol#: 79

 

LET 10434   Natural Organics Inc.                     Vol#: 79

 

LET 10435   Natural Organics Inc.                     Vol#: 79

 

LET 10436   Natural Organics Inc.                     Vol#: 79

 

LET 10437   Natural Organics Inc.                     Vol#: 79

 

LET 10438   Natural Organics Inc.                     Vol#: 79

 

LET 10439   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10440   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10441   Enzymatic Therapy Natural Medicines       Vol#: 79

 

LET 10442   Enzymatic Therapy Natural Medicines       Vol#: 79

 

LET 10443   Enzymatic Therapy Natural Medicines       Vol#: 79

 

LET 10444   Enzymatic Therapy Natural Medicines       Vol#: 79

 

LET 10445   Noow Foods                                Vol#: 79

 

LET 10446   Now Foods                                 Vol#: 79

 

LET 10447   Now Foods                                 Vol#: 79

 

LET 10448   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10449   Emnzymatic Therapy Natural Medicines      Vol#: 79

 

LET 10450   Enzymatic Therapy Natural Medicines       Vol#: 79

 

LET 10451   Enzymatic Therapy Natural Medicines       Vol#: 79

 

LET 10452   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10453   Edge Labs Inc.                            Vol#: 79

 

LET 10454   Edge Labs Inc.                            Vol#: 79

 

LET 10455   Edge Labs Inc.                            Vol#: 79

 

LET 10456   Edge Labs Inc.                            Vol#: 79

 

LET 10457   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10458   Enzymatic Therapy Natural Medicines       Vol#: 79

 

LET 10459   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10460   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10461   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10462   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10463   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10464   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10465   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10466   PhytoPharmica Natural Medicines           Vol#: 79

 

LET 10467   Enzymatic Therapy natural Medicines       Vol#: 79

 

LET 10468   Alltech, Inc.                             Vol#: 79

 

LET 10469   PhytoPharmica natural Medicines           Vol#: 79

 

LET 10470   Lane Labs USA, Inc.                       Vol#: 79

 

LET 10471   Enzymatic Therapy Natural Medicines       Vol#: 79

 

98D-1146  Microbial effects of antimicrobial new animal drugs/human sa

EMC 678     Trisha Alfermann                          Vol#: 19

 

EMC 679     Laurie Foster                             Vol#: 19

98P-0610  Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

C   49      Pfizer, Inc.                              Vol#: 5

 

99D-5435  Draft Guidance for Industry on Photosafety Testing

GDL 2       Guidance                                  Vol#: 1

 

NAD 2                                                 Vol#: 1

99F-4372  National Fisheries Institute and the Louisiana Dep of Agricu

SUP 3       Public Citizen                            Vol#: 7

 

99F-5321  Food Safety & Inspection service safe use of ionizing radiai

SUP 3       Public Citizen                            Vol#: 7

 

99F-5322  Ionizing Radiation for the Treatment of Food

SUP 3       Public Citizen                            Vol#: 5

 

99F-5522  Ionizing radiation /control of Food-borne pathogens safe use

SUP 3       Public Citizen                            Vol#: 5

00N-1571  Enrofloxacin for Poultry: Opportunity for Hearing

RMO 24      Center for Veterinary Medicine            Vol#: 368

 

RMO 25      Center for Veterinary Medicine            Vol#: 368

 

01F-0047  Foodborne pathogens in raw-frozen-cooked-partially cooked

SUP 3       Public Citizen                            Vol#: 7

 

01N-0539  Proposal to Debar Edwin Kokes;Notice of Opportunity for Hear

NFR 1                                                 Vol#: 1

01P-0470  Establish Appropriate Approval Standards for Generic Clonidi

LET 3       Elan Drug Delivery, Inc.                  Vol#: 2

 

LST 1       Elan Drug Delivery, Inc.                  Vol#: 2

 

02D-0095  Exposure-Response Relationship;Study Design,Data Analysis

GDL 2       GUIDANCE                                  Vol#: 1

 

NAD 2                                                 Vol#: 1

 

02D-0468  Manufacture and Labeling of Raw Meat Foods

C   14      Janeen Kincaid                            Vol#: 1

 

02E-0064  Patent Extension Application for Tracleer, No. 5,292,740

N   1                                                 Vol#: 1

 

02N-0359  Ingrown Toenail Relief drug products OTC human use

NFR 1                                                 Vol#: 1

02N-0528  Risk Management Workshop, April 9-11, 2003 [PDUFA III]

C   7       Abbott Laboratories                       Vol#: 3

02N-0534  Medical Device User Fee and Modernization Act of 2002

C   30      B. Braun Medical, Inc.                    Vol#: 2

 

02V-0523  Laser Light Show

VRA 1       HFZ-300 to Louisiana Arts & Science Muse  Vol#: 1

 

03D-0060  Part11, Electronic records, electronic signatures scope

C   30      National Grain & Feed Assn                Vol#: 3

 

C   31      Medrad                                    Vol#: 3

 

C   32      Merck KGaA                                Vol#: 3

 

EMC 10      Japan Pharmaceutical Manufacturers Assn   Vol#: 2

 

EMC 11      Society of Quality Assurance              Vol#: 2

 

EMC 12      The Hollis Group, Inc.                    Vol#: 2

 

EMC 13      SEC Associates, Inc.                      Vol#: 2

 

EMC 14      Phase Forward                             Vol#: 2

 

EMC 15      Schering-Plough Research Institute        Vol#: 2

 

EMC 16      American Assn of Blood Banks (AABB)       Vol#: 2

 

EMC 17      IBM Business Consulting Services          Vol#: 2

 

03D-0112  Independent Consultants for Biotechnology Clinical Trias

GDL 1       Guideline                                 Vol#: 1

 

NAD 1                                                 Vol#: 1

03D-0163  Blood Product Safety in Cases of Suspected SARS,Severe Acute

C   3       University of California at Davis Medica  Vol#: 1

 

C   4       Community Blood Bank of the Lancaster Co  Vol#: 1

 

C   5       Community Blood Center of the Ozarks      Vol#: 1

 

03D-0165  Current Good Manufacturing Practices for Medical Gases

GDL 1       GUIDANCE                                  Vol#: 1

 

NAD 1                                                 Vol#: 1

 

03N-0134  Team Biologics Program Effectiveness; Public Meeting

APE 33      PDA, Inc.                                 Vol#: 1

 

APE 34      Quintiles Consulting                      Vol#: 1

 

APE 35      Regulatory Resources, Inc.                Vol#: 1

 

03N-0143  Continued Over-the-Counter Status of Ipecac Syrup

NM  1                                                 Vol#: 1

 

03N-0161  Medical Devices;Reprocessed Single-Use Devices;Termination

N   1                                                 Vol#: 1

03P-0107  Synthroid (levothyroxine sodium) Tablets (NDA 21-402)

PAV 1       HFD-1 to Mylan Pharmaceuticals Inc.       Vol#: 1

03P-0113  Levoxyl (levothyroxine sodium) tablets (NDA #21-301)

PAV 1       HFD-1 to Mylan Pharmaceuticals, Inc.      Vol#: 1

 

03V-0054  Laser Light Show

VRA 1       HFZ-300 to Louis J. Roussel, Jr. Planet   Vol#: 1

 

03V-0192

ACK 1       HFA-305 to  Fun Factory Mobile DJ's       Vol#: 1

 

VAR 1       Fun Factory Mobile DJ's                   Vol#: 1