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Dockets Management
Dockets Entered On December 5, 2003
Table of Contents
Docket # Title
1981N-0033P Antiplaque & Antiplaque-Related Claims
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2003D-0385 Guidance for Industry: Comparability Protocols - Protein Drug Products and Biologic Products - Chemistry, Manufacturing, and Controls Information
2003E-0261 Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
2003N-0106 Using FDA forms 3503/3504 submissions Petitions,Food/color
2003N-0338 Obesity
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
2003P-0530 Silicone Gel-filled Breast Implants
1981N-0033P Antiplaque & Antiplaque-Related Claims
C 21 American Dental Association (ADA) Vol #: 86
SUP 3 WhiteHill Oral Technologies, Inc. Vol #: 86
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
C 236 E & B International, Inc Vol #: 17
EC 329 Lang, Florian Vol #: 17
EC 330 Rish, David Vol #: 17
EC 332 Powell, Susan Vol #: 17
EC 334 Parker, Glen Vol #: 17
EMC 127 J M Rice Vol #: 17
2003D-0385 Guidance for Industry: Comparability Protocols - Protein Drug Products and Biologic Products - Chemistry, Manufacturing, and Controls Information
C 3 PDA Vol #: 1
C 4 Aventis Pasteur Vol #: 1
C 5 Centocor Inc Vol #: 1
C 6 Genentech, Inc. Vol #: 1
EC 2 Whisler, Mary Faye Vol #: 1
EMC 2 Merck & Co., Inc. Vol #: 1
EMC 3 Biotechnology Industry Organization (BIO) Vol #: 1
2003E-0261 Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
N 1 FDA Vol #: 1
2003N-0106 Using FDA forms 3503/3504 submissions Petitions,Food/color
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2003N-0338 Obesity
C 12 Number not used Vol #: 86
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
EMC 20 unsigned Vol #: 1
EMC 21 unsigned Vol #: 1
EMC 22 Jan Vol #: 1
2003P-0530 Silicone Gel-filled Breast Implants
EMC 7 D Barnett Vol #: 1
EMC 8 CPotter Vol #: 1
PDN 1 HFZ-1 to Chemically Associated Neurological Disorders Vol #: 1

Page Posted December 8, 2003 dp
Page Updated December 24, 2003 jb

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