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 January 10, 2005
Table of Contents
Docket # Title
1989N-0378 Erythromycin Capsules; Proposed Amendment of Dissolution Std
1989P-0208 Establish standard of identity for frozen yogurt
1989P-0444 Amend Standards of Identity for Yogurt, Lowfat Yogurt et al
1990N-0361 Food Labeling, Declaration of Ingredients
1991N-0074 Aseptic Process/Terminal Sterilization of Pharmaceuticals
1991N-0245 Cosmetic Products Containing Certain Hormone Ingredients
1992N-0291 Drug Listing Compliance Verification Reports
1992N-0406 Food labeling; Metric Labeling Requirements
1992P-0441 Exempt from Preempt for use of NIST Handbook 133
1993M-0150 Nonroller-Type Cardiopulmonary Bypass Blood Pump
1993N-0044 Intent to Amend Performance Standard; Laser Products
1993N-0200 Quality Stds For Foods w/o Identity Standards; Bottled Water
1993N-0226 Quantity of Contents Labeling Requirements for Drugs, Animal
1993N-0467 Substances Prohibited From Use in Animal Food or Feed
1995N-0103 Labeling of foods with nutrient/health claims special requir
1995N-0189 Maltodextrin; Food Chemicals Codex Specifications
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2004D-0369 Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
2004D-0459 Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
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-0509 Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association
2004D-0510 Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
2004N-0458 Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
2004N-0559 Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
2004P-0472 refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
2004P-0488 Refrain from receiving, reviewing, and approving any ANDA for a nasal mupirocin calcium product that contains the amophous form of the active pharmaceutical ingredient.
2004P-0506 fentanyl transdermal products reduce the potential for abuse of certain types of these products
2004P-0540 Don't approve any new or pending ANDA for generic fentanyl transdermal product
2005V-0009 Projector for a Laser Light Show
1989N-0378 Erythromycin Capsules; Proposed Amendment of Dissolution Std
NWL 1 FDA Vol #: 1
1989P-0208 Establish standard of identity for frozen yogurt
NWL 1 FDA Vol #: 2
1989P-0444 Amend Standards of Identity for Yogurt, Lowfat Yogurt et al
NWL 1 FDA Vol #: 1
1990N-0361 Food Labeling, Declaration of Ingredients
NWL 1 FDA Vol #: 33
1991N-0074 Aseptic Process/Terminal Sterilization of Pharmaceuticals
NWL 1 FDA Vol #: 3
1991N-0245 Cosmetic Products Containing Certain Hormone Ingredients
NWL 1 FDA Vol #: 2
1992N-0291 Drug Listing Compliance Verification Reports
NWL 1 FDA Vol #: 1
1992N-0406 Food labeling; Metric Labeling Requirements
NWL 1 FDA Vol #: 1
1992P-0441 Exempt from Preempt for use of NIST Handbook 133
NWL 1 FDA Vol #: 10
1993M-0150 Nonroller-Type Cardiopulmonary Bypass Blood Pump
NWL 1 FDA Vol #: 1
1993N-0044 Intent to Amend Performance Standard; Laser Products
NWL 1 FDA Vol #: 2
1993N-0200 Quality Stds For Foods w/o Identity Standards; Bottled Water
NWL 1 FDA Vol #: 1
1993N-0226 Quantity of Contents Labeling Requirements for Drugs, Animal
NWL 1 FDA Vol #: 2
1993N-0467 Substances Prohibited From Use in Animal Food or Feed
NWL 1 FDA Vol #: 2
1995N-0103 Labeling of foods with nutrient/health claims special requir
NWL 1 FDA Vol #: 1
1995N-0189 Maltodextrin; Food Chemicals Codex Specifications
NWL 1 FDA Vol #: 1
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 15284 NBTY Inc. Vol #: 134
LET 15285 NBTY Inc. Vol #: 134
LET 15286 NBTY Inc. Vol #: 134
LET 15287 NBTY Inc. Vol #: 134
LET 15288 NBTY Inc. Vol #: 134
LET 15289 NBTY Inc. Vol #: 134
LET 15290 NBTY Inc. Vol #: 134
LET 15291 Perrigo Company of South Carolina Vol #: 134
LET 15292 Perrigo Company of South Carolina Vol #: 134
LET 15293 Perrigo Company of South Carolina Vol #: 134
LET 15294 Perrigo Company of South Carolina Vol #: 134
LET 15295 Perrigo Company of South Carolina Vol #: 134
LET 15296 Hansen Beverage Company Vol #: 134
LET 15297 Hansen's Beverage Company Vol #: 134
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 833 Bayer Corporation Vol #: 472
EXB 834 Bayer Corporation Vol #: 472
EXB 835 Bayer Corporation Vol #: 472
EXB 836 Bayer Corporation Vol #: 472
EXB 837 Bayer Corporation Vol #: 472
EXB 838 Bayer Corporation Vol #: 472
EXB 839 Bayer Corporation Vol #: 472
EXB 840 Bayer Corporation Vol #: 472
EXB 841 Bayer Corporation Vol #: 472
EXB 842 Bayer Corporation Vol #: 472
EXB 843 Bayer Corporation Vol #: 472
EXB 844 Bayer Corporation Vol #: 472
EXB 845 Bayer Corporation Vol #: 472
EXB 846 Bayer Corporation Vol #: 472
EXB 847 Bayer Corporation Vol #: 472
EXB 848 Bayer Corporation Vol #: 472
EXB 849 Bayer Corporation Vol #: 472
EXB 850 Bayer Corporation Vol #: 472
EXB 851 Bayer Corporation Vol #: 472
EXB 852 Bayer Corporation Vol #: 472
2004D-0369 Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
EMC 460 S Goldstein Vol #: 8
EMC 461 J Westbrook Vol #: 8
EMC 462 M Safran Vol #: 8
EMC 463 J McDaniel Vol #: 8
EMC 464 B Weimann Vol #: 8
EMC 465 HL Tyler Vol #: 8
EMC 466 J Shippee Vol #: 8
EMC 467 K Turner Vol #: 8
EMC 468 M Harper Vol #: 8
EMC 469 D Sussman Vol #: 8
EMC 470 B Hupe Vol #: 8
EMC 471 L Acton Vol #: 8
EMC 472 S Urang Vol #: 8
EMC 473 T Bell Vol #: 8
EMC 474 R Martin Vol #: 8
EMC 475 H Smith Vol #: 8
EMC 476 M Milton Vol #: 8
EMC 477 S Rosenfeld Vol #: 8
EMC 478 C May Vol #: 8
EMC 479 M Mihok Vol #: 8
EMC 480 K Kapela Vol #: 8
EMC 481 S Callahan Vol #: 8
EMC 482 S Wright Vol #: 8
EMC 483 J Shaw Vol #: 8
EMC 484 S Carter Vol #: 8
EMC 485 S Baker Vol #: 8
EMC 486 J WIlson Vol #: 8
EMC 487 L Lambeth Vol #: 8
EMC 488 J Naar Vol #: 8
EMC 489 D Knutzen Vol #: 8
EMC 490 D Snyder Vol #: 8
EMC 491 B Gottlieb Vol #: 8
EMC 492 M Johnston Vol #: 8
EMC 493 Number not used Vol #: 8
EMC 494 A Riegel Vol #: 8
EMC 495 R Palme Vol #: 8
EMC 496 N Timm Vol #: 8
EMC 497 P Baginski Vol #: 8
EMC 498 B Green Vol #: 8
EMC 499 D Moon Vol #: 8
EMC 500 D Sater Vol #: 8
EMC 501 D Botticelli Vol #: 8
EMC 502 G Coughlin Vol #: 8
EMC 503 M Girouard Vol #: 8
EMC 504 P Decker Vol #: 8
EMC 505 W Unger Vol #: 8
EMC 506 K Chapman Vol #: 8
EMC 507 S Benoit Vol #: 8
EMC 508 A Abdelatey Vol #: 8
EMC 509 E Moomaw Vol #: 8
EMC 510 R Volpe Vol #: 8
EMC 511 J Fassett Vol #: 8
EMC 512 M Hershey Vol #: 8
EMC 513 P Wirth Vol #: 8
EMC 514 Number not used Vol #: 8
EMC 515 S Kepner Vol #: 8
EMC 516 M Schelley Vol #: 8
EMC 517 N Aldrich Vol #: 8
EMC 518 P Rickman Vol #: 8
EMC 519 S Balkenhol Vol #: 8
EMC 520 S Guarnaccia Vol #: 8
EMC 521 D Schalliol Vol #: 8
EMC 522 M George Vol #: 8
EMC 523 G Griffith Vol #: 8
EMC 524 G Peters Vol #: 8
EMC 525 R Miller Vol #: 8
EMC 526 L Cortellesi Vol #: 8
EMC 527 J Hopkins Vol #: 8
EMC 528 T Aber Vol #: 8
EMC 529 L Hutchingsw Vol #: 8
EMC 530 J Hanson Vol #: 8
EMC 531 J Chirillo Vol #: 8
EMC 532 E Wagner Vol #: 8
EMC 533 D McColley Vol #: 8
EMC 534 J Jenkins Vol #: 8
EMC 535 A Koosed Vol #: 8
EMC 536 R Klein Vol #: 8
EMC 537 Y Yeh Vol #: 8
EMC 538 P Wilczynski Vol #: 8
EMC 539 B Imam Vol #: 8
EMC 540 R Orlof Vol #: 8
EMC 541 A Raster Vol #: 8
EMC 542 E deLaczay Vol #: 8
EMC 543 PI Norton Vol #: 8
EMC 544 M Satter Vol #: 8
EMC 545 J McMullen Vol #: 8
EMC 546 Dr. J Flanagan Vol #: 8
EMC 547 M Blackwell Vol #: 8
EMC 548 J Straw Vol #: 8
EMC 549 J Rowe Vol #: 8
EMC 550 J Cedrone Vol #: 8
EMC 551 M Mello Vol #: 8
EMC 552 C Whitehead Vol #: 8
EMC 553 K Nawaz Vol #: 8
EMC 554 K D'Andrea Vol #: 8
EMC 555 J Stender Vol #: 8
EMC 556 J Hindman Vol #: 8
EMC 557 P Stone Vol #: 8
EMC 558 G Blumenthal Vol #: 8
EMC 559 N Schmader Vol #: 8
EMC 560 F Szwec Vol #: 8
EMC 561 G Giannelli Vol #: 8
EMC 562 E Gargost Vol #: 8
2004D-0459 Guidance for Industry on Pharmacokinetics in Pregnancy Study Design, Data Analysis, and Impact on Dosing and Labeling
C 1 AstraZeneca Pharmaceuticals, LP Vol #: 1
C 2 Bristol-Myers Squibb Company (BMS) Vol #: 1
C 3 Abbott Laboratories Vol #: 1
C 4 GlaxoSmithKline (GSK) Vol #: 1
2004D-0466 Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
C 1 American Society for clinical Pharmacology and Therapeutics (ASCPT) Vol #: 1
2004D-0509 Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association
C 1 National Food Processors Assn (NFPA) Vol #: 1
2004D-0510 Live & Perishable Fish & Fishery Products for Export to the European Union and the European Free Trade Association
C 1 National Food Processors Assn (NFPA) Vol #: 1
2004N-0458 Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
C 1 American Society for Clinical Pharmacology and Therapeutics (ASCPT) Vol #: 1
2004N-0559 Overall benefit to risk considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents
C 1 M. Rose Vol #: 1
2004P-0472 refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
SUP 1 Daniel Brookoff, MD, PhD and Eric A. Voth, MD, FACP Vol #: 2
2004P-0488 Refrain from receiving, reviewing, and approving any ANDA for a nasal mupirocin calcium product that contains the amophous form of the active pharmaceutical ingredient.
SUP 1 GlaxoSmithKline (GSK) Vol #: 1
2004P-0506 fentanyl transdermal products reduce the potential for abuse of certain types of these products
C 2 Noven Pharmaceuticals, Inc. Vol #: 2
2004P-0540 Don't approve any new or pending ANDA for generic fentanyl transdermal product
C 1 Mylan Technologies, Inc. (Mylan) Vol #: 1
C 2 Noven Pharmaceuticals, Inc. (Noven) Vol #: 1
2005V-0009 Projector for a Laser Light Show
ACK 1 HFA-305 to To Be Determined Vol #: 1
VAR 1 To Be Determined Vol #: 1

Page created on December 11, 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