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DOCKETS
ENTERED on May 2, 2003
Docket Number - Title
75N-183H
Health-Care Antiseptic Drug Products for OTC Human Use
94P-0036
Req labeling of trans fatty acid & prohibit deceptive claims
97S-0162
30-Day Structure Function Claim Notification Letters Dietary
00P-1322
Food Labeling and Allergen Contamination Control
02N-0204
Bar Code Label Requirements for human drug products
02N-0528
Risk Management Workshop, April 9-11, 2003 [PDUFA III]
02P-0435
Effective Approval of Alphanate Antihemophilic Factor
03D-0001
Nonclinical Safety Evaluation of Pediatric Drug Products
LET 38 HFD-1 to Soap & Detergent Assn. & CTFA Vol#: 149
LET 39 HFD-560 to Ben M. Durham, Jr. Vol#: 149
94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST
C 8582 Annamarie Harrod et al Vol#: 116
C 2463 Elaine W. Vol#: 71
C 2464 Martha E. Viner Vol#: 71
C 2465 Brenda Millette Vol#: 71
C 2466 Claire L. Renn Vol#: 71
C 2467 Teri Tibbits Vol#: 71
C 2468 Priscilla Castellano Vol#: 71
C 2469 Linda Winter Vol#: 71
C 2470 Reda J. Short Vol#: 71
C 2471 Mrs. Frances Eglow Vol#: 71
C 2472 Fay C. Graning Vol#: 71
C 2473 Cherie Rickett Vol#: 71
C 2474 Cecile Nebel Vol#: 71
C 2475 Bernice Schneider Vol#: 71
C 2476 Dr. Mary R. Laner Vol#: 71
C 2477 Ms. Virginia R. Hay Vol#: 71
C 2478 Gractia P. Austin Vol#: 71
C 2479 Mrs. Eleanor McIntosh Vol#: 71
C 2480 Deborah Clawson Vol#: 71
C 2481 Phyllis & Edward Ball Vol#: 71
C 2482 Colleen Kirby Vol#: 71
C 2483 Martin Kaloostian Vol#: 71
C 2484 Shirley Newton Vol#: 71
C 2485 Mary L. Mayer Vol#: 71
C 2486 Dorothy D. Berg Vol#: 71
C 2487 Ms. Agnes Annunziata Vol#: 71
C 2488 Norma L. Kaecker Vol#: 71
C 2489 Mrs. Joy Grijalva Vol#: 71
C 2490 Russell Hammond Vol#: 71
C 2491 J. Blauster, RN, ANP Vol#: 71
C 2492 E. Dunn Vol#: 71
C 2493 J. Rigney Vol#: 71
C 2494 Josephine & Philip McKibben Vol#: 71
C 2495 Nancy & Leroy Sprey Vol#: 71
C 2496 P.L. Borman Vol#: 71
C 2497 Bette & Bob Rockow Vol#: 71
C 2498 Gene E. Carbone Vol#: 71
C 2499 Fran Hast Vol#: 71
C 2500 Steve Oppenheim Vol#: 71
C 2501 Abigail E. Worstell Vol#: 71
C 2502 Ms. Holly Rothkopf Vol#: 71
C 2503 E. Vol#: 71
C 2504 Johnson Quinn Vol#: 71
C 2505 Judy Wiss Vol#: 71
C 2506 J. Alice Felicia, M.A., L.P. Vol#: 71
C 2507 Inez Diamond Vol#: 71
C 2508 Amy L. Vandersall Vol#: 71
C 2509 Clifford Hames Vol#: 71
C 2510 Ag Radio Network, Inc. Vol#: 71
C 2511 Mrs. J. M. Gerstley Vol#: 71
C 2512 Susan V. Messina et al Vol#: 71
C 2513 Moise E. Berger Vol#: 71
C 2514 Harold O. Walker Vol#: 71
C 2515 Bill & Marilyn Voorhies Vol#: 71
C 2516 Betty Lou Wells Vol#: 71
C 2517 Ronald C. West Vol#: 71
C 2518 Loraine Campbell Vol#: 71
C 2519 John D. Mancuso Vol#: 71
C 2520 Judy Harvey Vol#: 71
C 2521 Carol A. Watson Vol#: 71
C 2522 Jeanne Jo L'Heureux Vol#: 71
C 2523 Janan C. Henry Vol#: 71
C 2524 Roselene Haines Vol#: 71
C 2525 Jack Altman Vol#: 71
C 2526 Linda Quimby Vol#: 71
C 2527 Michael Rossa Vol#: 71
LET 10193 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10194 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10195 Enzymatic Therapy Natural Medicines Vol#: 77
LET 10196 Perrigo Company of South Carolina Vol#: 77
LET 10197 Perrigo Company of South Carolina Vol#: 77
LET 10198 Perrigo Company of south Carolina Vol#: 77
LET 10199 Perrigo Company of South Carolina Vol#: 77
LET 10200 Perrigo Company of South Carolina Vol#: 77
LET 10201 Perrigo Company of South Carolina Vol#: 77
LET 10202 Perrigo Company of South Carolina Vol#: 77
LET 10203 Perrigo Company of South Carolina Vol#: 77
LET 10204 Perrigo Company of South Carolina Vol#: 77
LET 10205 Bayer Corporation Vol#: 77
LET 10222 NBTY, Inc. Vol#: 77
LET 10243 BNBTY, Inc. Vol#: 77
LET 10276 PhytoPharmica Natural Medicines Vol#: 77
LET 10277 PhytoPharmica Natural Medicines Vol#: 77
LET 10278 PhytoPharmica Natural Medicines Vol#: 77
00N-1396 Bioengineered Foods Consumed By Humans or Animals
EMC 11562 Shannon Walker Vol#: 349
C 527 HFS-821 to Ms. Ruth Schneider Vol#: 30
EMC 498 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 499 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 500 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 501 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 502 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 503 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 504 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 505 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 506 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 507 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 508 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 509 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 510 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 511 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 512 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 513 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 514 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 515 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 516 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 517 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 518 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 519 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 520 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 521 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 522 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 523 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 524 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 525 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 526 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 527 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 528 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 529 The Food Allergy & anaphylaxis Network Vol#: 20
EMC 530 The Food Allergy & anaphylaxis Network Vol#: 20
01P-0230 Domestic Marketing & Importation of Transgenic Fish
EMC 2722 James Hosey Vol#: 228
01P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1175 George Bakos Vol#: 5
02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 109 Brent Kirkman, PhD Vol#: 3
EMC 110 Carol Greenwood Vol#: 3
C 38 Precision Dynamics Corporation Vol#: 13
LET 3 HF-40 to Precision Dynamics Corporation Vol#: 13
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities
EMC 84 DGN-Ministry of Economy Mexico Vol#: 10
EMC 85 Min of Foreign Trade & Tourism of Peru Vol#: 10
EMC 86 European Communities Vol#: 10
EMC 87 National Standardization Agency of Indoe Vol#: 10
02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
EMC 106 DGN-Ministry of Economy Mexico Vol#: 11
EMC 107 Min of Foreign Trade & Tourism of Peru Vol#: 11
EMC 108 National Standardization Agency of Indoe Vol#: 11
EMC 109 National Standardization Agency of Indoe Vol#: 11
EMC 110 National Standardization Agency of Indoe Vol#: 11
EMC 11 Pharm Printed Literatire Assn (PPLA) Vol#: 2
EMC 12 Global Pharmacovigilance Vol#: 2
EMC 13 National Assn of Chain Drug Stores Vol#: 2
EMC 14 Pharmaceutical Printed Literature Assn Vol#: 2
EMC 15 Millennium Pharmaceuticals, Inc. Vol#: 2
EMC 16 Pinney Associates, Inc. Vol#: 2
EMC 17 Academy of Managed Care Pharmacy Vol#: 2
C 16 Long Island Jewish Medical Center Vol#: 1
C 17 Orthopaedic Hospital Vol#: 1
C 18 University of Milan Vol#: 1
C 19 University of Colorado Health Sciences Vol#: 1
C 6 Aventis Pharmaceuticals, Inc. Vol#: 1
03D-0060 Part11, Electronic records, electronic signatures scope
EMC 9 F. Hoffmann-La Roche, Ltd Vol#: 2
03M-0172 PMA Cypher Sirolimus-Eluting Coronary Stent on the Raptor
AAV 1 Cordis Corporation Vol#: 1