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Dockets Management
Dockets Entered On March 23, 2004
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2003E-0458 Patent Extension, Velcade, bortezomib, #5,780,454
2004P-0141 NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 13380 Aboca USA, Inc. Vol #: 110
LET 13381 Ortho Molecular Products, Inc. Vol #: 110
LET 13382 Aboca USA, Inc. Vol #: 110
LET 13383 Aboca USA, Inc. Vol #: 110
LET 13384 Aboca USA, Inc. Vol #: 110
LET 13385 Aboca USA, Inc. Vol #: 110
LET 13386 Aboca USA, Inc. Vol #: 110
LET 13387 Aboca USA, Inc. Vol #: 110
LET 13388 Aboca USA, Inc. Vol #: 110
LET 13389 PhytoPharmica Natural Medicines Vol #: 110
LET 13390 PhytoPharmica Natural Medicines Vol #: 110
LET 13391 Enzymatic Therapy Natural Medicines Vol #: 111
LET 13392 Botanic Gardens, Inc. Vol #: 111
LET 13393 Botanic Gardens, Inc. Vol #: 111
LET 13394 Botanic Gardens, Inc. Vol #: 111
LET 13395 Botanic Gardens, Inc. Vol #: 111
LET 13396 Botanic Gardens, Inc. Vol #: 111
LET 13397 SLC Sweet Inc. Vol #: 111
LET 13398 Tabak's Health Products Vol #: 111
LET 13399 Enzymatic Therapy Natural Medicines Vol #: 111
LET 13400 PhytoPharmica Natural Medicines Vol #: 111
LET 13401 Source Naturals Vol #: 111
LET 13402 Source Naturals Vol #: 111
LET 13403 Nutronix International Vol #: 111
LET 13404 Nutronix International Vol #: 111
LET 13405 Nutronix International Vol #: 111
LET 13406 Nutronix International Vol #: 111
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 483 Form Letters Vol #: 199
C 484 K. Scheffles Vol #: 201
C 485 J. Sotheran, PhD Vol #: 201
C 486 R. Mark Vol #: 201
C 487 Women's Institute for Fertility, Endocrinology and Menopause Vol #: 201
C 488 Dartmouth-Hitchcock Medical Center Vol #: 201
C 489 University of New Mexico Vol #: 201
C 490 P. LaPointe Vol #: 201
C 491 H. Zaluski,MD,MA Vol #: 201
C 492 E. Godfrey,MD,MPH Vol #: 201
C 493 Advocate Lutheran General Hospital Vol #: 201
C 494 Partners Women Health Center Vol #: 201
C 495 K. Shields Vol #: 201
C 496 N. Guinn, MD Vol #: 201
C 497 University of California, Berkeley Vol #: 201
C 498 Albemarle Nephrology Associates Vol #: 201
C 499 K. Anhold Vol #: 201
C 500 L. Fuller, MD Vol #: 201
C 501 Children's Hospital at Albany Medical Center Vol #: 201
C 502 G. Wachtell Vol #: 201
C 503 Illegible Vol #: 201
C 504 A. Armstrong Vol #: 201
C 505 N. Stotland,MD Vol #: 201
C 506 S. McPhee Vol #: 201
C 507 Emory University School of Medicine Vol #: 201
C 508 R. Steinmetz Vol #: 201
C 509 Santa Clara Family Medical Center Vol #: 201
C 510 J. Curry,PA-C Vol #: 201
C 511 J. McLean Vol #: 201
C 512 Brigham and Women's Hospital Vol #: 201
C 513 P. Palm,MS,RNC Vol #: 201
C 514 Illegible Vol #: 201
C 515 G. Missey Vol #: 201
C 516 J. Beach Vol #: 201
C 517 S. Morian Vol #: 201
C 518 6 signatures Vol #: 201
C 519 Illegible Vol #: 201
C 520 I. Carr Vol #: 201
C 521 R. Rex Vol #: 201
C 522 D. Christiansen, MD Vol #: 201
C 523 Northwestern Perinatal Associates, SC Vol #: 201
C 524 North Colorado Family Medicine Vol #: 201
C 525 R. Kierstead Vol #: 201
C 526 B. Raymond Vol #: 201
C 527 R. Nevin Rupp, MD Vol #: 201
C 528 Univeristy of New Mexico School of Medicine Vol #: 201
C 529 C. Keegan,MD Vol #: 201
C 530 K. Shields Vol #: 201
C 531 L. Garmoe Vol #: 201
C 532 Planned Parenthood of Louisville Vol #: 201
C 533 D. Chasan Vol #: 201
C 534 C. Farrell Vol #: 201
C 535 A. Lang Vol #: 201
C 536 P. Kaune Vol #: 201
C 537 J. Sanchez Vol #: 201
C 538 E. and B. Sauber Vol #: 201
C 539 M and B. Sauber Vol #: 201
C 540 R. Estrada Vol #: 201
C 541 E. McCay Vol #: 201
C 542 D. Beninati,MD,FACOG Vol #: 201
C 543 M. Gillette Vol #: 201
C 544 S. and E. Meether Vol #: 201
C 545 N. Hermes Vol #: 201
C 546 J. Lashua Vol #: 201
C 547 M. Powers Vol #: 201
C 548 J. Piciocco Vol #: 201
C 549 L. Gonzalez, RN,PNP Vol #: 201
C 550 Illegible Vol #: 201
C 551 R. Ernstein Vol #: 201
C 552 L. Kooima Vol #: 201
C 553 M. Kleissler Vol #: 201
C 554 R. McGovern Vol #: 201
C 555 V. Fubelli Vol #: 201
C 556 M. Govola,RN,BSN Vol #: 201
C 557 J. Edwards Vol #: 201
C 558 P. Pishlli Vol #: 201
C 559 M. Heck Vol #: 201
C 560 H. Bottum Vol #: 201
C 561 R. Dupres Vol #: 202
C 562 G. Vanengen Vol #: 201
C 563 M. Roberson Vol #: 202
C 564 A. Johnson Vol #: 202
C 565 A. Benedict Vol #: 202
C 566 L. Manarte Vol #: 202
C 567 K. Benedict Vol #: 202
C 568 K. Kutz Vol #: 202
C 569 C. Pellizzari Vol #: 202
C 570 M. Cunningham Vol #: 202
C 571 C. Campbell Vol #: 202
C 572 M. Koons Vol #: 202
C 573 A. DiFonzo, Sr. Vol #: 202
C 574 M. Upperman Vol #: 202
C 575 M. Graham Vol #: 202
C 576 P. Gebhardt Vol #: 202
C 577 C. Schmitz Vol #: 202
C 578 D. McDonald,MDPA Vol #: 202
C 579 S. Holmes Vol #: 202
C 580 New York Nurses for Life, Inc. Vol #: 202
C 581 B. Coupal Vol #: 202
C 582 Vital Signs Ministries Vol #: 202
C 583 M. June Vol #: 202
C 584 M. Grigattis Vol #: 202
C 585 L. Shisler Vol #: 202
C 586 C. Wheeler Vol #: 202
C 587 A. McClellan Vol #: 202
C 588 C. Hill Vol #: 202
C 589 B. Kelly Vol #: 202
C 590 S. Solano,MD Vol #: 202
C 591 P. Coogan Vol #: 202
C 592 J. Doom Vol #: 202
C 593 N.G. Wagner Vol #: 202
C 594 E. Carleton Vol #: 202
C 595 B. Glasenhardt Vol #: 202
C 596 Illegible Vol #: 202
C 597 M and D Sauser Vol #: 202
C 598 Illegible Vol #: 202
C 599 A. Roche Vol #: 202
C 600 B. Painell Vol #: 202
C 601 D. Welch Vol #: 202
C 602 B. Stoll, RN Vol #: 202
C 603 No signature Vol #: 202
C 604 No signature Vol #: 202
C 605 L. Knight Vol #: 202
C 606 S. Feeney Vol #: 202
C 607 M. Reidy Vol #: 202
C 608 M. Starr Vol #: 202
C 609 H. Sankey,MD,FACOG,CPE Vol #: 202
C 610 S. Scherer Vol #: 202
C 611 L. Baker Vol #: 202
C 612 J, Curry,PA-C Vol #: 202
C 613 K and W Chase Vol #: 202
C 614 C. Keegan, MD Vol #: 202
C 615 Dartmouth-Hitchcock Medical Center Vol #: 202
C 616 P. Adelstein, MD Vol #: 202
C 617 K. Bright Vol #: 202
C 618 The Permanente Medical Group, Inc. Vol #: 202
C 619 F. O'Connell Vol #: 202
C 620 R. Dimick Vol #: 202
C 621 D. Wiley, PhD Vol #: 202
C 622 D. Holman Vol #: 202
C 623 55 signatures Vol #: 202
C 624 S. Carpenter, MD Vol #: 202
C 625 M. Lykke Vol #: 202
C 626 Montgomery County Commission for Women Vol #: 202
C 627 A. Waterson Vol #: 202
C 628 B. Stone Vol #: 202
C 629 M. Creinin, MD Vol #: 202
C 630 K. O'Boyle Vol #: 202
C 631 H. Sankey,MD,FACOG,CPE Vol #: 202
C 632 Northwestern University Vol #: 202
C 633 Brigham and Women's Hospital Vol #: 202
C 634 R. Linn Vol #: 202
C 635 D. Wiley, PhD Vol #: 202
C 636 E. Simoneau Vol #: 202
C 637 Bruce Ferguson, MD, LLC Vol #: 202
C 638 Univeristy of California San Francisco Vol #: 202
C 639 University of New mexico School of Medicine Vol #: 202
C 640 Planned Parenthood Vol #: 202
C 641 R. Sarah Vol #: 202
C 642 S. Ranz, R.Ph Vol #: 202
C 643 A. Spielvogel, MD Vol #: 202
C 644 S. Leavitt, MD Vol #: 202
C 645 LSU University Vol #: 202
C 646 F. Guerra,MD,MPH Vol #: 202
C 647 Illegible Vol #: 202
C 648 E. Strang Vol #: 202
C 649 E. Schurman Vol #: 202
C 650 University of Montana Women's Center Vol #: 202
C 651 University of Wisconsin-Madison Medical School Vol #: 203
C 652 Southwestern Medical Center Vol #: 203
C 653 D. Vice Vol #: 203
C 654 D. Lynch Vol #: 203
C 655 J. Auth Vol #: 203
C 656 J. Reid Vol #: 203
C 657 M. Colosimo Vol #: 203
C 658 B. Robinson Vol #: 203
C 659 T. Robinson Vol #: 203
C 660 S. Berros Vol #: 203
C 661 A. Kaune Vol #: 203
EMC 4901 G. W. McGuffin Vol #: 170
EMC 4902 J. Sutor Vol #: 170
EMC 4903 M. Bartter Vol #: 170
EMC 4904 J. Cleave Vol #: 170
EMC 4905 C. Kosuda Vol #: 170
EMC 4906 CE Gac Vol #: 170
EMC 4907 N. Files Vol #: 170
EMC 4908 J. J. Logie Vol #: 170
EMC 4909 B. Thompson Vol #: 170
EMC 4910 B. D. A. Kirby Vol #: 170
EMC 4911 B. Weatherby Vol #: 170
EMC 4912 L. Carson Vol #: 170
EMC 4913 N. Karaitis Vol #: 170
EMC 4914 T. Howell Vol #: 170
EMC 4915 M. Feldaman Vol #: 170
EMC 4916 M. Gillem Vol #: 170
EMC 4917 A. Garg Vol #: 170
EMC 4918 P. Ehrhorn Vol #: 170
EMC 4919 A. Davis Vol #: 170
EMC 4920 W. A. Watts Jr Vol #: 170
EMC 4921 S. Vickers Vol #: 170
EMC 4922 T. Ouellette Vol #: 170
EMC 4923 J. Mckenny Vol #: 170
EMC 4924 N. Struthers Vol #: 170
EMC 4925 Magdalena K Vol #: 170
EMC 4926 C. Gonzalez Vol #: 170
EMC 4927 J. E. Peabody Vol #: 170
EMC 4928 M. Stanfill Vol #: 170
EMC 4929 L. Crawford Vol #: 170
EMC 4930 S. Lafontant Vol #: 170
EMC 4931 S. Thatcher Vol #: 170
EMC 4932 J. De Reu Vol #: 170
EMC 4933 D. Geidenberger Vol #: 170
EMC 4934 A. Wyper Vol #: 170
EMC 4935 P. True Vol #: 170
EMC 4936 T. Dobson Vol #: 170
EMC 4937 J. Lopez Vol #: 170
EMC 4938 R. C. Sachs Vol #: 170
EMC 4939 K. I. Menges Vol #: 170
EMC 4940 J. F. Dinkmeyer Vol #: 170
EMC 4941 J. C. Tiedemann Vol #: 170
EMC 4942 T. Ewing Vol #: 170
EMC 4943 T. Bush Vol #: 170
EMC 4944 J. & L. Lund Vol #: 170
EMC 4945 B. Dale Vol #: 170
EMC 4946 H. Lake Vol #: 170
EMC 4947 V. D. Oliva Vol #: 170
EMC 4948 S. Singler Vol #: 170
EMC 4949 M. Hanbey Vol #: 170
EMC 4950 D. Scherer Vol #: 170
EMC 4951 S. A. Syberg Vol #: 170
EMC 4952 S. L. Weaver Vol #: 170
EMC 4953 S. Erfurth Vol #: 170
EMC 4954 K. E. Cline Vol #: 170
EMC 4955 K M. Wetzel Vol #: 170
EMC 4956 E. J. Schoop Vol #: 170
EMC 4957 M. L. Grolimond Vol #: 170
EMC 4958 L. L. Miller Vol #: 170
EMC 4959 C. Lininger Vol #: 170
EMC 4960 N. Field Vol #: 170
EMC 4961 S. Salinas Vol #: 170
EMC 4962 F. Nadelman LMSW, Vol #: 170
EMC 4963 K. Westberg Vol #: 170
EMC 4964 M. Burba Vol #: 170
EMC 4965 E. Arnold Vol #: 170
EMC 4966 J. R. Anderson Vol #: 170
EMC 4967 J. Albrecht Vol #: 170
EMC 4968 A. Ashton Vol #: 170
EMC 4969 R. Braker Vol #: 170
EMC 4970 J. Bryctha , RNC Vol #: 170
EMC 4971 B. Phillips Vol #: 170
EMC 4972 T. D. Bailey Vol #: 170
EMC 4973 J. Black Vol #: 170
EMC 4974 R. Smith Vol #: 170
EMC 4975 S. Burridge Vol #: 170
EMC 4976 S.Godwin Vol #: 170
EMC 4977 R. Bottner Vol #: 170
EMC 4978 K.Quigley Vol #: 170
EMC 4979 N.Golub Vol #: 170
EMC 4980 J. Ainger Vol #: 170
EMC 4981 C. Fox & P. Grove Vol #: 170
EMC 4982 L. Minervini Vol #: 170
EMC 4983 H. Hendricks Vol #: 170
EMC 4984 K. Haas Vol #: 170
EMC 4985 A. Swanson Vol #: 170
EMC 4986 R. Holson Vol #: 170
EMC 4987 P. M. Plonski Vol #: 170
EMC 4988 L. Fuqua Vol #: 170
EMC 4989 J.Calhoun Vol #: 170
EMC 4990 J. Walton Vol #: 170
EMC 4991 H. J. Hart Vol #: 170
EMC 4992 N. F. Wechsler Vol #: 170
EMC 4993 S. Reich Vol #: 170
EMC 4994 J. Caddell Vol #: 170
EMC 4995 C. Veltri Vol #: 170
EMC 4996 S.W. Matthes Vol #: 170
EMC 4997 D. Kalins Vol #: 170
EMC 4998 R. Finkbine Vol #: 170
EMC 4999 J. Pena Vol #: 170
EMC 5000 A. Sheinwald Vol #: 170
EMC 5001 V. Smith Vol #: 170
EMC 5002 J. George Vol #: 170
EMC 5003 R. M. Prins Vol #: 170
EMC 5004 W. Bellwood Vol #: 170
EMC 5005 P. Klemperer Vol #: 170
EMC 5006 L. Pacheco Vol #: 170
EMC 5007 B. Sirelson Vol #: 170
EMC 5008 W. C. Marsh Vol #: 170
EMC 5009 B. Johnson Vol #: 170
EMC 5010 P. Sinclair Vol #: 170
EMC 5011 K. Minkus Vol #: 170
EMC 5012 B. Shaffer Vol #: 170
EMC 5013 J. Breheney Vol #: 170
EMC 5014 S. Lanzarotta Vol #: 170
EMC 5015 S. Maurer Vol #: 170
EMC 5016 B. K.Sisk Vol #: 170
EMC 5017 B. Rosenberg Vol #: 170
EMC 5018 B. Molchan Vol #: 170
EMC 5019 R. F. Earls Vol #: 170
EMC 5020 B. J. Lacasse Vol #: 170
EMC 5021 B. Galvin Vol #: 170
EMC 5022 A. Crisafulli Vol #: 170
EMC 5023 B. Kalarness Vol #: 170
EMC 5024 E. J. Kelly Vol #: 170
EMC 5025 V. Muchowski Vol #: 170
EMC 5026 S. Rigney Vol #: 170
EMC 5027 P. J. Maybruck Vol #: 170
EMC 5028 R. Schwartz Vol #: 170
EMC 5029 A. Runyard Vol #: 170
EMC 5030 B. Fritz Vol #: 170
EMC 5031 M. H. MacGillivary Vol #: 170
EMC 5032 M. S. Graham Vol #: 170
EMC 5033 D. Thompson Vol #: 170
EMC 5034 T. Mertig Vol #: 170
EMC 5035 E. Wiley Vol #: 170
EMC 5036 D. Adams Vol #: 170
EMC 5037 A. Garrison Vol #: 170
EMC 5038 E. Friedman Vol #: 170
EMC 5039 K. Wilinson Vol #: 170
EMC 5040 A. Chinni Vol #: 170
EMC 5041 M. Milkman Vol #: 170
EMC 5042 K. Hoppennbrouwers Vol #: 170
EMC 5043 N. Laurent Vol #: 170
EMC 5044 O. Leckert Vol #: 170
EMC 5045 K. P. Vol #: 170
EMC 5046 R. Rivera Vol #: 170
EMC 5047 B. Ewing Vol #: 170
EMC 5048 M. Ingersoll Vol #: 170
EMC 5049 B. A. Marian Vol #: 170
EMC 5050 M. J. Keley Vol #: 170
EMC 5051 C. Caramagno Vol #: 170
EMC 5052 S. Sherry Vol #: 170
EMC 5053 M.Nashman Vol #: 170
EMC 5054 N. Cole Vol #: 170
EMC 5055 S. Hack Vol #: 170
EMC 5056 L. Duram Vol #: 170
EMC 5057 K. Pierce Vol #: 170
EMC 5058 L. A. Curry Vol #: 170
EMC 5059 G. Hunt Vol #: 170
EMC 5060 J. F. Kohler Vol #: 170
EMC 5061 J. Blasingame Vol #: 170
2003E-0458 Patent Extension, Velcade, bortezomib, #5,780,454
N 1 FDA Vol #: 1
2004P-0141 NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons
ACK 1 Abbott Laboratories Vol #: 1
CP 1 Abbott Laboratories Vol #: 1

Page created on March 23, 2004 kk
Page updated on April 5, 2004 rc

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