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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
C 125 Quest International, Flavors & Food Ingr Vol#: 13
EXT 4 Salt Institute Vol#: 13
NEC 4 Vol#: 13
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
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
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 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
99D-5435 Draft Guidance for Industry on Photosafety Testing
GDL 2 Guidance Vol#: 1
NAD 2 Vol#: 1
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
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
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
C 7 Abbott Laboratories Vol#: 3
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
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
PAV 1 HFD-1 to Mylan Pharmaceuticals Inc. Vol#: 1
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