FDA Logo links to FDA home page
U.S. Food and Drug Administration
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status

horizonal rule

Dockets Management
Dockets Entered On February 2, 2005
Table of Contents
Docket # Title
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2004D-0466 Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
2004D-0468 Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
2004D-0510 Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
2004N-0503 Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
2004N-0559 Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
2004N-0565 Agency Information Collection Activities; Proposed Collection;
2004P-0472 refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
2005N-0040 Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack with Anthrax
2005P-0048 Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
2005P-0050 ANDA Suitability for Colistimethate Sodium 150 mg/2 mL Solution
2005P-0051 Approve bottled water labels include either fluoride added or no fluride added
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 1030 Bayer Corporation Vol #: 478
EXB 1031 Bayer Corporation Vol #: 478
EXB 1032 Bayer Corporation Vol #: 478
EXB 1033 Bayer Corporation Vol #: 478
EXB 1034 Bayer Corporation Vol #: 478
EXB 1035 Bayer Corporation Vol #: 478
EXB 1036 Bayer Corporation Vol #: 478
EXB 1037 Bayer Corporation Vol #: 478
EXB 1038 Bayer Corporation Vol #: 478
EXB 1039 Bayer Corporation Vol #: 478
EXB 1040 Bayer Corporation Vol #: 478
EXB 1041 Bayer Corporation Vol #: 478
EXB 1042 Bayer Corporation Vol #: 478
EXB 1043 Bayer Corporation Vol #: 478
EXB 1044 Bayer Corporation Vol #: 478
EXB 1045 Bayer Corporation Vol #: 478
EXB 1046 Bayer Corporation Vol #: 478
EXB 1047 Bayer Corporation Vol #: 478
EXB 1048 Bayer Corporation Vol #: 478
2004D-0466 Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
EMC 3 M. Chaturvedi Vol #: 3
2004D-0468 Draft Guidance for Industry on Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for use in Animals
EMC 1 J. Green Vol #: 1
2004D-0510 Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
EMC 3 Interocean Seafoods Co. Vol #: 1
2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
EMC 461 D. Mindock Vol #: 8
EMC 462 C. Krueger Vol #: 8
EMC 463 C. Davis Vol #: 8
EMC 464 T. Schaffer Vol #: 8
EMC 465 A. Castellano Vol #: 8
EMC 466 Z. Walden Vol #: 8
EMC 467 S. Davis Vol #: 8
EMC 468 J. Novinsky Vol #: 8
EMC 469 D. and D Nesbitt Vol #: 8
EMC 470 W. Degler Vol #: 8
EMC 471 S. Rutkowski Vol #: 8
EMC 472 B. Cook Vol #: 8
EMC 473 R. Kunstmann Vol #: 8
EMC 474 W. Chapman Vol #: 8
EMC 475 B. Smith Vol #: 8
EMC 476 N. Stevens Vol #: 8
EMC 477 C. Beaver Vol #: 8
EMC 478 D. Howell Vol #: 8
EMC 479 W. Frado Vol #: 8
EMC 480 I. LaGrone Vol #: 8
EMC 481 J. Bartalini Vol #: 8
EMC 482 E. Kushner Vol #: 8
EMC 483 C. Johnson Vol #: 8
EMC 484 M. Walusek Vol #: 8
EMC 485 M. Ayers Vol #: 8
EMC 486 J. Marcus Vol #: 8
EMC 487 R. Kost Vol #: 8
EMC 488 A. Hargreaves Vol #: 8
EMC 489 N. Schimmel Vol #: 8
EMC 490 P. Mlynarcik Vol #: 8
EMC 491 C. Hannan Vol #: 8
EMC 492 K. Timmons Vol #: 8
EMC 493 C. Hollenshead Vol #: 8
EMC 494 P. Acker Vol #: 8
EMC 495 R. Rhoades Vol #: 8
EMC 496 D. Pettibone Vol #: 8
EMC 497 D. Davenport Vol #: 8
EMC 498 M. Acker Vol #: 8
EMC 499 C. Barrow Vol #: 8
EMC 500 D. Meenen Vol #: 8
EMC 501 E. Nash Vol #: 8
EMC 502 J. Neill Vol #: 8
EMC 503 D. Hall Vol #: 8
EMC 504 C. Liu Vol #: 8
EMC 505 A. Ours Vol #: 8
EMC 506 D. Henry Vol #: 8
EMC 507 E. Gaska Vol #: 8
EMC 508 C. Trainum Vol #: 8
EMC 509 R. Stambaugh Vol #: 8
EMC 510 J. Martin Vol #: 8
EMC 511 H. Fields Vol #: 8
EMC 512 J. Thomspon Vol #: 8
EMC 513 J. Ostoich Vol #: 8
EMC 514 R. Grindle Vol #: 8
EMC 515 M. Hance Vol #: 8
EMC 516 P. Nastasi Vol #: 8
EMC 517 M. Shearer Vol #: 8
EMC 518 D. Sourelis Vol #: 8
EMC 519 B. Anderson Vol #: 8
EMC 520 G. Bennett Vol #: 8
EMC 521 A. Hillberry Vol #: 8
EMC 522 B. Brown Vol #: 8
EMC 523 J. Saltzman Vol #: 8
EMC 524 S. Hannon Vol #: 8
EMC 525 K. Peterson Vol #: 8
2004N-0503 Agency Information Collection Activities: Proposed Collection; Comment Request: Guidance on Consultation Procedures; Foods Derived From New Plant Varieties
EMC 2 T. Weiss Vol #: 1
2004N-0559 Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
EMC 1 No signature Vol #: 1
2004N-0565 Agency Information Collection Activities; Proposed Collection;
EMC 1 B. Sachau Vol #: 1
2004P-0472 refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
EMC 2 Noven Pharmaceuticals, Inc. (Noven) Vol #: 2
2005N-0040 Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack with Anthrax
BKG 1 Background Material Vol #: 1
LET 1 DHHS Vol #: 1
NAD 1 FDA Vol #: 1
2005P-0048 Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
ACK 1 HFA-305 to McNeil Consumer & Specialty Pharmaceuticals Vol #: 1
CP 1 McNeil Consumer & Specialty Pharmaceuticals Vol #: 1
2005P-0050 ANDA Suitability for Colistimethate Sodium 150 mg/2 mL Solution
ACK 1 HFA-305 to Pharmaceutical Resources Group Consulting Vol #: 1
CP 1
Attachment 1, 2 		Pharmaceutical Resources Group Consulting Vol #: 1
2005P-0051 Approve bottled water labels include either fluoride added or no fluride added
ACK 1 HFA-305 to Ed Groves, Sr. Vol #: 1
CP 1 Ed Groves, Sr. Vol #: 1

Page created on February 3, 2005 dp

horizonal rule

Dockets Home| Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility

FDA/Dockets Management