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DOCKETS
ENTERED on April 30, 2003
Docket Number - Title
80N-0280 Vaginal
Contraceptive Drug Products for OTC Use
94P-0036 Req labeling of
trans fatty acid & prohibit deceptive claims
95N-0304 Ephedrine
Alkaloids: Reports of Adverse Events; Availability
96N-0417 CGMP in Mfg.
Packing or Holding Dietary Supplements
97S-0162 30-Day Structure
Function Claim Notification Letters Dietary
99D-1458 Enforcement
Policy for FDA Personnel/Electronic Records& Sig
00N-1219 Bacterial
Vaccines & Related Biological Products
02N-0204 Bar Code Label
Requirements for human drug products
02N-0528 Risk Management
Workshop, April 9-11, 2003 [PDUFA III]
02P-0447 Immediately
revoke its acceptance for NDA 21-435 for amlodin
C 57 American
College of Obstetricians & Gyne Vol#: 12
C 2435
Marianne Kibler Whiting Vol#: 70
C 2436
Stephen J. Biello, III Vol#: 70
C 2437
Richard Bergschneider Vol#: 70
C 2438
Anna M. Ott Vol#: 70
C 2439
Kathy Maynard Vol#: 70
C 2440
Eric & Sharon Siggins Vol#: 70
C 2441
Nancy Ellen Locke Vol#: 70
C 2442 Durango
Dental Associates Vol#: 70
C 2443
Cynthia Foote Vol#: 70
C 2444
George H. Holt Vol#: 70
C 2445
Wildwood Vol#: 70
C 2446
Gay Block Vol#: 70
C 2447
Harry Kenton Vol#: 70
C 2448
Marjorie Boerio Vol#: 70
C 2449
Robert J. Telepak, M.D. Vol#: 70
C 2450
Ellen Mierzewski Vol#: 70
C 2451
Neil R. Ericsson Vol#: 70
C 2452
Karen Winters Vol#: 70
C 2453
Thomas J. Gibson Vol#: 70
C 2454
Florence Friedman Vol#: 70
C 2455
Joseph Dowd Vol#: 70
LET
22 HFS-830 to Lyman S. Stanton Vol#: 70
C 4007 Terry
Laboratories Vol#: 348
C 4008
Anthony Raissen Vol#: 348
C 4009 Lauren Raissen Vol#: 348
C 4010
Larry Kitay Vol#: 348
C 4011
ICM Vol#: 348
C 4012
Edward A. Daigle Vol#: 348
C 4013
Form Letter 33 Vol#: 370
C 4014
Form Letter 3 Vol#: 371
C 4015
orm Letter 44
Vol#: 372
C 4016
Form Letter 21 Vol#: 373
C 107 Kos
Pharmaceuticals, Inc. Vol#: 7
LET
10102 Nutrition Now, Inc. Vol#: 76
LET
10103 PhytoPharmica natural Medicines
Vol#: 76
LET
10104 Enzymatic Therapy Nautral Medicines
Vol#: 76
LET
10105 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10106 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10107 Enzymatic Therapy natural Medicines
Vol#: 76
LET
10108 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10109 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10110 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10111 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10112 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10113 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10114 Enzymatic Therapy Natural medicines
Vol#: 76
LET
10115 Lifetime Technologies Vol#: 76
LET
10116 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10117 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10118 Enzymatic Therapy natural Medicines
Vol#: 76
LET
10119 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10120 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10121 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10122 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10123 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10124 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10125 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10126 Enzymatic Therapy Natural
Medicines Vol#: 76
LET
10127 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10128 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10129 Colin Worldwide Corporation Vol#: 76
LET
10130 Vita Cube System, Inc. Vol#: 76
LET
10131 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10132 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10133 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10136 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10137 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10138 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10139 Enzymatic Therapy Natural Medicines
Vol#: 76
LET
10140 Met-RX USA, Inc. Vol#: 76
LET
10141 Met-RX USA, Inc. Vol#: 76
LET
10142 Met-RX USA, Inc. Vol#: 76
LET
10143 Met-RX USA, Inc. Vol#: 76
LET
10144 Met-RX USA, Inc. Vol#: 76
LET
10145 Met-RX USA, Inc. Vol#: 76
LET
10146 Met-RX USA, Inc. Vol#: 76
LET
10147 Met-RX USA, Inc. Vol#: 76
LET
10148 Met-RX USA,. Inc. Vol#: 76
LET
10149 Met-RX USA, Inc. Vol#: 76
LET
10150 Met-RX USA, Inc. Vol#: 76
LET
10151 Met-RX USA, Inc. Vol#: 76
LET
10152 Met-RX USA, Inc. Vol#: 76
LET
10153 Met-RX USA, Inc. Vol#: 76
LET
10154 Met-RX USA, Inc. Vol#: 76
LET
10155 Met-RX USA, Inc. Vol#: 76
98P-0151 Introduction Of Downed Cattle Into The Food
Supply
EMC
3195 Nakashima Family Vol#: 265
EMC
3196 Mrs. Kreisman Vol#: 265
EMC
3197 Julie Brush Vol#: 265
EMC
3198 Mrs. Cynthia Brandes Vol#: 265
EMC
3199 Bryant Vol#: 265
EMC
3200 Bassam Imam Vol#: 265
C 8 American
Red Cross Vol#: 1
C 10 Industry
Coalition Vol#:
1
C 12 Wyeth
Pharmaceuticals Vol#: 1
C 13 Aventis
Pharmaceuticals, Inc. Vol#: 1
C 14 National
Electrical Manufacturers Assn Vol#: 1
C 15 Dow
Chemical Company Vol#: 1
C 16 Purdue
Pharma L.P. Vol#: 1
C 17 SEC
Associates, Inc. (SEC) Vol#: 1
C 39
American Red Cross Vol#: 9
C 40
PhRMA Vol#: 9
C 41
Industry Coalition Vol#: 9
C 42
CTFA Vol#: 9
C 43
Wyeth Pharmaceuticals Vol#: 9
C 44
Aventis Pharmaceuticals, Inc. Vol#: 9
C 45
National Electrical Manufacturers Assn Vol#: 9
C 46
Dow Chemical Company Vol#: 9
C 47
Purdue Pharma L.P. Vol#: 9
C 48
SEC Associates, Inc. (SEC) Vol#: 9
00D-1539 Electronic
Records & Signatures, Retention of Electronic Rec
C 32
American Red Cross Vol#: 9
C 33
PhRMA Vol#: 9
C 34
Industry Coalition Vol#: 9
C 35
CTFA Vol#: 9
C 36
Wyeth Pharmaceuticals Vol#: 9
C 37
National Electrical Manufacturers Assn Vol#: 9
C 38
Aventis Pharmaceuticals, Inc. Vol#: 9
C 39
Dow Chemical Company Vol#: 9
C 40
Purdue Pharma L.P. Vol#: 9
C 41
SEC Associates, Inc. (SEC) Vol#: 9
00D-1542 Electronic
Signatures: Time Stamps
C 17
American Red Cross Vol#: 7
C 18
PhRMA Vol#: 7
C 19
Industry Coalition Vol#: 7
C 20
CTFA Vol#: 1
C 21
Wyeth Pharmaceuticals Vol#: 7
C 22
National Electrical Manufacturers Assn Vol#: 7
C 23
Aventis Pharmaceuticals, Inc. Vol#: 7
C 24
Dow Chemical Company Vol#: 7
C 25
Purdue Pharma L.P. Vol#: 7
C 26
SEC Associates, Inc. (SEC)
Vol#: 7
00D-1543 Electronic
Signatures: Glossary of Terms
C 27
American Red Cross Vol#: 7
C 28
PhRMA Vol#: 7
C 29
Industry Coalition Vol#: 7
C 30
CTFA Vol#: 7
C 31
Wyeth Pharmaceuticals Vol#: 7
C 32
National Electrical Manufacturers Assn Vol#: 7
C 33
Aventis Pharmaceuticals, Inc. Vol#: 7
C 34 Dow Chemical
Company Vol#: 7
C 35
Purdue Pharma L.P. Vol#: 7
C 36
SEC Associates, Inc. (SEC) Vol#: 7
SUP
1 Delmont Laboratories, Inc. Vol#: 2
01P-0230 Domestic Marketing & Importation of
Transgenic Fish
EMC
2721 Christopher Squires Vol#: 228
02E-0064 Patent Extension Application for Tracleer,
No. 5,292,740
APP
1 Hoffmann-LaRoche Inc. Vol#: 1
LET
1 U.S. Patent & Trademark
Office Vol#: 1
02E-0184 Patent Extension Application for XIGRIS, No.
5,681,932
APP
1 Eli Lilly and Company Vol#: 1
LET
1 U.S. Patent & Trademark
Office Vol#: 1
02E-0342 Lea's Shield, U.S. Patent No. 4,703,752
APP
1 Shlomo Gabbay Vol#: 1
LET
1 U.S. Patent & Trademark
Office Vol#: 1
C 34 Air
Liquide America LP Vol#: 13
C 4 AstraZeneca
Pharmaceuticals, LP Vol#: 2
C 5 American
Medical Assn (AMA) Vol#: 2
03D-0060 Part11, Electronic records, electronic
signatures scope
C 14
American Red Cross Vol#: 1
C 15
CTFA Vol#: 1
C 16
Industry Coalition Vol#: 1
C 17
PhRMA Vol#: 1
C 18
Purdue Pharma L.P. Vol#: 1
C 19
SEC Associates, Inc. (SEC) Vol#: 1
C 20
Dow Chemical Company Vol#: 1
C 21
Aventis Pharmaceuticals, Inc. Vol#: 1
C 22
National Electrical Manufacturers Assn Vol#: 1
C 23
Wyeth Pharmaceuticals Vol#: 1
C 24
Taratec Development Corporation Vol#: 1
C 25
James G. Robertson, P.E. Vol#: 1