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Dockets Management
Dockets Entered On July 6, 2004
Tabe of Contents
Docket # Title
1981N-0033P Antiplaque & Antiplaque-Related Claims
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
2004N-0033 Factor VIII Inhibitors
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
2004N-0242 Institutional Review Boards; Registration Requirements
2004P-0285 To determine whether Aciphex (rabeprazole sodium) delayed-release tablets, 10mg (NDA 20-973) has been voluntarily withdrawn or withheld from sale for safety or effectiveness reasons
2004V-0284 Projector for a laser light show
1981N-0033P Antiplaque & Antiplaque-Related Claims
BKG 3 Background Material Vol #: 87
NRD 2 FDA Vol #: 86
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
C 350 Reunion Island Coffee Limited Vol #: 29
EC 494 British Foods Inc Vol #: 29
EC 495 SPS Enquiry Point of China Vol #: 29
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
C 10 BASF Aktionegesellschaft Vol #: 2
C 11 SST Corporation Vol #: 2
C 12 Schering-Plough Vol #: 3
C 13 Animal Health Institute Vol #: 2
C 14 AFAQuim (asociacion espanola de fabricantes de productos de quimica fina) Vol #: 2
C 15 Novartis Pharmaceuticals Corporation Vol #: 2
C 16 Procter & Gamble Pharmaceuticals Vol #: 2
C 17 Hoffmann-La Roche Inc Vol #: 2
C 18 Wyeth Pharmaceuticals Vol #: 2
C 19 Millennium Pharmaceuticals Inc Vol #: 2
C 20 Noramco Inc Vol #: 2
C 21 Abbott Laboratories Vol #: 2
EC 4 Novartis Pharmaceuticals Corp. Vol #: 2
EC 5 Eli Lilly and Company Vol #: 2
EC 6 Merck KGaA, Germany Vol #: 2
EMC 2 Pfizer Research and Development Vol #: 2
2004N-0033 Factor VIII Inhibitors
N 1 FDA Vol #: 1
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
NM 3 FDA Vol #: 1
2004N-0242 Institutional Review Boards; Registration Requirements
NPR 1 FDA Vol #: 1
2004P-0285 To determine whether Aciphex (rabeprazole sodium) delayed-release tablets, 10mg (NDA 20-973) has been voluntarily withdrawn or withheld from sale for safety or effectiveness reasons
ACK 1 HFA-305 to Lachman Consultant Services, Inc Vol #: 1
CP 1 Lachman Consultant Services, Inc Vol #: 1
2004V-0284 Projector for a laser light show
ACK 1 HFA-305 to Jose Ayala Vol #: 1
VAR 1 Jose Ayala Vol #: 1

Page created on July 7, 2004 kk

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