DOCKETS ENTERED on April 30, 2003

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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

80N-0280 Vaginal Contraceptive Drug Products for OTC Use

C 57 American College of Obstetricians & Gyne Vol#: 12

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

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

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

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

96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements

C 107 Kos Pharmaceuticals, Inc. Vol#: 7

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

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 10134 NBTY, Inc. Vol#: 76

LET 10135 NBTY, Inc. 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

99D-1458 Enforcement Policy for FDA Personnel/Electronic Records& Sig

C 8 American Red Cross Vol#: 1

C 9 PhRMA Vol#: 1

C 10 Industry Coalition Vol#: 1

C 11 CTFA 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

00D-1538 Electronic Records; Electronic Signatures, Validation

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

00N-1219 Bacterial Vaccines & Related Biological Products

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 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