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Dockets Management
Dockets Entered On September 29, 2003
Table of Contents
Docket # Title
1975N-0183H Health-Care Antiseptic Drug Products for OTC Human Use
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998D-1146 Microbial effects of antimicrobial new animal drugs/human sa
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2000P-0685 Revise of Yogurt Standards
2002D-0124 Notifying FDA of Fatalities Related to Blood & Transfusion
2002N-0486 Prescription Drug Marketing Act of 1987
2003E-0457 Patent Extension, SOMAVERT, pegisomant for injection, #5,849,535
2003E-0458 Patent Extension, Velcade, bortezomib, #5,780,454
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0344 Consumer-Directed Promotion; Public Meeting
2003N-0424 Agency Information Collection Activities: Proposed Collection; Comment Request;
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
2003P-0140 Refrain from Approving ANDAs for Topical Mupirocin Ointment
2003P-0171 Amend the standard of identity for canned tomatoes.
2003P-0366 Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
2003P-0453 Abbreviated new drug applications (ANDAs) for hhydrocodone bitartrate
2003V-0454 Variance for Denlaser 800
1975N-0183H Health-Care Antiseptic Drug Products for OTC Human Use
SUP 11 Aplicare, Inc. Vol #: 200
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 11076 Twin Laboratories, Inc Vol #: 84
LET 11077 Aboca Herbs and Health Vol #: 84
LET 11078 Aboca Herbs and Health Vol #: 84
LET 11079 Tabak's health Products Vol #: 84
LET 11080 Natural 2U Vol #: 84
1998D-1146 Microbial effects of antimicrobial new animal drugs/human sa
N 1 FDA Vol #: 62
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7039 Joan Carey Vol #: 299
C 7040 Mrs. Diane Small Vol #: 299
C 7041 Bruce & Marilyn Foote Vol #: 299
C 7042 Elizabeth I. Jones Vol #: 299
C 7043 Raquel Fuentes Vol #: 299
C 7044 Mrs. Daniel Donahue Vol #: 299
C 7045 Abby J. Glackin Vol #: 299
C 7046 Jolene Deakins Vol #: 299
C 7047 Manijeh & John Sadri Vol #: 299
C 7048 Wesley Davis Vol #: 299
C 7049 Barbara Perry Vol #: 299
2000P-0685 Revise of Yogurt Standards
C 8 Snow Brand Milk Products Co., Ltd. Vol #: 1
2002D-0124 Notifying FDA of Fatalities Related to Blood & Transfusion
GDL 2 GUIDANCE Vol #: 1
NAD 2 FDA Vol #: 1
2002N-0486 Prescription Drug Marketing Act of 1987
SS 1 Support Statment Vol #: 1
2003E-0457 Patent Extension, SOMAVERT, pegisomant for injection, #5,849,535
APP 1 Pharmacia Corp Vol #: 1
LET 1 U S Patent and Trademark Office Vol #: 1
2003E-0458 Patent Extension, Velcade, bortezomib, #5,780,454
APP 1 Millennium Pharmaceuticals, Inc Vol #: 1
LET 1 U S Patent and Trademark Office Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EXT 5 Grocery Manufacturers of America (GMA) Vol #: 1
2003N-0344 Consumer-Directed Promotion; Public Meeting
CR 1 Pfizer, Inc Vol #: 2
LST 1 Agenda for September 22, 2003 Meeting Vol #: 2
TS 1
Powerpoint version
Ohio Northern University Vol #: 2
2003N-0424 Agency Information Collection Activities: Proposed Collection; Comment Request;
N 1 FDA Vol #: 1
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
LET 1
Attachment
HFS-800 to International Dairy Foods Assn Vol #: 1
2003P-0140 Refrain from Approving ANDAs for Topical Mupirocin Ointment
LET 1 HFD-5 to Hogan & Hartson, LLP Vol #: 1
2003P-0171 Amend the standard of identity for canned tomatoes.
LET 1
Attachment
HFS-800 to Keller and heckman, LLP Vol #: 1
2003P-0366 Amend approval for a nonprescription form of Prilosec (omeprazole magnesium)
C 1 Covington & Burling Vol #: 1
2003P-0453 Abbreviated new drug applications (ANDAs) for hydrocodone bitartrate
ACK 1 HFA-305 to King & Spalding LLP Vol #: 1
CP 1
Tab A, B, C, D
King & Spalding LLP Vol #: 1
2003V-0454 Variance for Denlaser 800
ACK 1 HFA-305 to CAO Group Inc. Vol #: 1
VAR 1 CAO Group Inc. Vol #: 1

Page Posted September 30, 2003
Page updated October 7, 2003 jb

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