August 3, 2004
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Dockets Management
Dockets Entered On July 15, 2004
Table of Contents
Docket # Title
1981N-0033 Oral Health Care Drug Products for OTC Human Use
1998E-0488 Gonal-F (follitropin alpha/beta; U.S. Patent Ext # 5,156,957
1998E-0852 Patent Extension # 5,298,520 MAXALT (rizatriptan Benzoate)
1998E-1221 Celexa; Patent Term Extension Application,No.4,650,884
1999E-1086 Enbrel, Patent No. 5,712,155
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2001E-0053 Patent Extension for Diphenylmethane diisocyanate, 4,968,514
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002E-0019 Patent Term Application for Axert No. 5,565,447
2002E-0339 Benicar, U.S. Patent No. 5,616,599
2003E-0033 Patent Extension Application for DERMAGRAFT No. 4,963,489
2003E-0247 Patent Extension for Campath (Alemtuzumab), 5,545,403
2004D-0160 Use of Unapproved Hormone Implants in Veal Calves
2004E-0023 Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
2004E-0040 Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
2004E-0307 Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
2004E-0308 Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
2004E-0314 Patent Extension for Spiriva HandiHaler (tiotropium bromide inhalation powder), U.S. Patent No. 5,610,163
2004E-0316 Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943
2004E-0319 Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
2004N-0081 BSE Risk Materials in Foods and Cosmetics
2004N-0257 Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
2004N-0279 Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
2004N-0291 Risk Assessment for Cosmetics and Potential Contamination with Bovine Spongiform Encephalopathy Agent
2004P-0315 Switch Pseudoephedrine from Over the Counter (OTC) Sales
2004P-0320 Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
2004V-0317 Laser Light Show
2004V-0318 Laser Light Show
1981N-0033 Oral Health Care Drug Products for OTC Human Use
ACK 5 HFA-305 to Dyclo9, Inc. Vol #: 70
CP 5 Dyclo9, Inc. Vol #: 70
1998E-0488 Gonal-F (follitropin alpha/beta; U.S. Patent Ext # 5,156,957
LET 5 U.S. Patent & Trademark Office Vol #: 1
1998E-0852 Patent Extension # 5,298,520 MAXALT (rizatriptan Benzoate)
LET 4 U.S. Patent & Trademark Office Vol #: 1
1998E-1221 Celexa; Patent Term Extension Application,No.4,650,884
LET 4 U.S. Patent & Trademark Office Vol #: 1
1999E-1086 Enbrel, Patent No. 5,712,155
LET 3 U.S. Patent & Trademark Office Vol #: 1
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 292 Center for Veterinary Medicine Vol #: 420
EXB 293 Center for Veterinary Medicine Vol #: 420
EXB 294 Center for Veterinary Medicine Vol #: 420
EXB 295 Center for Veterinary Medicine Vol #: 420
EXB 296 Center for Veterinary Medicine Vol #: 420
2001E-0053 Patent Extension for Diphenylmethane diisocyanate, 4,968,514
LET 5 U.S. Patent & Trademark Office Vol #: 1
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 7605 J. Manders Vol #: 280
EMC 7606 J. Haladay Vol #: 280
EMC 7607 J. Reid Vol #: 280
EMC 7608 A. Clifford Vol #: 280
EMC 7609 C. Baker Vol #: 280
EMC 7610 F. E. Murray Vol #: 280
EMC 7611 J. S. Cornette Vol #: 280
EMC 7612 H. Hauserman Vol #: 280
EMC 7613 K. A. Walter Vol #: 280
EMC 7614 A. Bodenhemier Vol #: 280
EMC 7615 C. Sommer Vol #: 280
EMC 7616 H. Kent Vol #: 280
EMC 7617 E. Knapp Vol #: 280
EMC 7618 C. Nussbaum Vol #: 280
EMC 7619 C. M. Halsey Vol #: 280
EMC 7620 E. Dubnoff Vol #: 280
EMC 7621 K. McManus Vol #: 280
EMC 7622 L. Morey Vol #: 280
EMC 7623 M. Beaty Vol #: 280
EMC 7624 T. Meyer Vol #: 280
EMC 7625 K. Wrenn Vol #: 280
EMC 7626 C. M. Larson Vol #: 280
EMC 7627 B. Morse Vol #: 280
EMC 7628 J. Granger Vol #: 280
EMC 7629 T. K. Wishart Vol #: 280
EMC 7630 A. E. Lydon Vol #: 280
EMC 7631 V. R. Durost Vol #: 280
EMC 7632 D. Evans Vol #: 280
EMC 7633 K. Maring Vol #: 280
EMC 7634 J. Markowitz Vol #: 280
EMC 7635 J. Bailey Vol #: 280
EMC 7636 K. McLennan Vol #: 280
EMC 7637 C. Wessel Vol #: 280
EMC 7638 G. R. Cullen Vol #: 280
EMC 7639 K. Sweitzer Vol #: 280
EMC 7640 K. E. Lovaas Vol #: 280
EMC 7641 K. L. Crow Vol #: 280
EMC 7642 J. Thacker Vol #: 280
EMC 7643 K. Bowsher Vol #: 280
EMC 7644 M. Shepard Vol #: 280
EMC 7645 H. Hirsch Vol #: 280
EMC 7646 N. Trainer Vol #: 280
EMC 7647 D. Valentine Vol #: 280
EMC 7648 J. Van Nostrand Vol #: 280
EMC 7649 B. Dunn Vol #: 280
EMC 7650 B. Dunn Vol #: 280
EMC 7651 Rev. L. R. Somers Vol #: 280
EMC 7652 A. L. Kirby Vol #: 280
EMC 7653 L. J. Gersicoff Vol #: 280
EMC 7654 K. Lazor Vol #: 280
EMC 7655 J. Callahan Vol #: 280
EMC 7656 R. Stewart Vol #: 280
EMC 7657 L. K. Cassandra Vol #: 280
EMC 7658 L. S. Bailey Vol #: 280
EMC 7659 J. Goussot Vol #: 280
EMC 7660 D. F. Herden Vol #: 280
EMC 7661 S. Barrett-Page Vol #: 280
EMC 7662 M. VandenBerg Vol #: 280
EMC 7663 J. Williamson Vol #: 280
EMC 7664 L. P. McGuire Vol #: 280
EMC 7665 M. Grim Vol #: 280
EMC 7666 J. Troncao Vol #: 280
EMC 7667 C. Catskill Vol #: 280
EMC 7668 D. Burkhart Vol #: 280
EMC 7669 H. L. Orn Vol #: 280
EMC 7670 J. L. Hartshorn Vol #: 280
EMC 7671 J. Reed Vol #: 280
EMC 7672 M. Halpern Vol #: 280
EMC 7673 C. Clouse Vol #: 280
EMC 7674 M. Samuel Vol #: 280
EMC 7675 O. Robertson Vol #: 280
EMC 7676 E. Johnson Vol #: 280
EMC 7677 L. Weinberg Vol #: 280
EMC 7678 J. Jackson Lusby Vol #: 280
EMC 7679 J. Troyer Vol #: 280
EMC 7680 A. Marshall Vol #: 280
EMC 7681 V. Heller Vol #: 280
EMC 7682 K. Hanson Vol #: 280
EMC 7683 L. S. Lerner Vol #: 280
EMC 7684 J. Morgan Vol #: 280
EMC 7685 L. E. Dunnington Vol #: 280
EMC 7686 H. Holliger Vol #: 280
EMC 7687 Kathleen Cox Vol #: 280
EMC 7688 L. Doubleday Vol #: 280
EMC 7689 s. Hottin Vol #: 280
EMC 7690 C. Hartwell Vol #: 280
EMC 7691 D. Williams Vol #: 280
EMC 7692 M. A. Boyse Vol #: 280
EMC 7693 H. Oliver Vol #: 280
EMC 7694 M. Bailey Vol #: 280
EMC 7695 D. Miller Vol #: 280
EMC 7696 K. Buchanan Vol #: 280
EMC 7697 J. Bonds Vol #: 280
EMC 7698 M. Pike Vol #: 280
EMC 7699 K. A. Spencer Vol #: 280
EMC 7700 M. Saunders Vol #: 280
EMC 7701 G. D. Gleckel Vol #: 280
EMC 7702 L. Jenkins Vol #: 280
EMC 7703 L. Taylor Vol #: 280
EMC 7704 A. F. Bezella Vol #: 280
EMC 7705 K. Walling Vol #: 280
EMC 7706 K. Rolfes Vol #: 280
EMC 7707 L. Metcalf Vol #: 280
EMC 7708 J. Mariette Vol #: 280
EMC 7709 J. L. S. Beck Vol #: 280
EMC 7710 K. Sergent Vol #: 280
EMC 7711 K. Fairchild Vol #: 280
EMC 7712 G. Morrow Vol #: 280
EMC 7713 J. Forman Vol #: 280
EMC 7714 M. Read Vol #: 280
EMC 7715 C. Lee Taylor Vol #: 280
EMC 7716 D. Solyan Vol #: 280
EMC 7717 A. Adams Vol #: 280
EMC 7718 M. Allekotte Vol #: 280
EMC 7719 A. Adams Vol #: 280
EMC 7720 R. Messano Vol #: 280
EMC 7721 R. A. Mendes Vol #: 280
EMC 7722 G. Potts Vol #: 280
EMC 7723 A. Riccone Vol #: 280
EMC 7724 V. LeBlanc Vol #: 280
EMC 7725 F. Campbell Vol #: 280
EMC 7726 J. E. Baldwin Vol #: 280
EMC 7727 C. Wright-Kaiser Vol #: 280
EMC 7728 M. Cantiello Vol #: 280
EMC 7729 M.M. Castro Vol #: 280
EMC 7730 E. Pleshe Vol #: 280
EMC 7731 J. Weinar Vol #: 280
EMC 7732 M. D. Hill Vol #: 280
EMC 7733 J. R. Moser Vol #: 280
EMC 7734 D. McNeill Vol #: 280
EMC 7735 K. Markley Vol #: 280
EMC 7736 K. Nunez Vol #: 280
EMC 7737 N. R. Wright Vol #: 280
EMC 7738 S. L. Forsythe Vol #: 280
EMC 7739 M. M. Smozski Vol #: 280
EMC 7740 L. Raiteri Vol #: 280
EMC 7741 M. Britton Vol #: 280
EMC 7742 M. Ferguson Vol #: 280
EMC 7743 M. Rutherford Vol #: 280
EMC 7744 K. Stamm Vol #: 280
EMC 7745 A. M. Delinasiou Vol #: 280
EMC 7746 J. Forrester Vol #: 280
EMC 7747 J. B. Sokolsky Vol #: 280
EMC 7748 D. Takach Vol #: 280
EMC 7749 KP Vol #: 280
EMC 7750 E. Lyons Vol #: 280
EMC 7751 K. Kirschling Vol #: 280
EMC 7752 B. Dalhover Vol #: 280
EMC 7753 L. Korin Vol #: 280
EMC 7754 S. Bolikal Vol #: 280
EMC 7755 L. Wagoner Vol #: 280
EMC 7756 J. Lauzon Vol #: 280
EMC 7757 j. M. Foss Vol #: 280
EMC 7758 G. Perkins Vol #: 280
EMC 7759 L. Prifogle Vol #: 280
EMC 7760 P. Hval Vol #: 280
EMC 7761 H. Nelson Vol #: 280
EMC 7762 M. Sneddon Vol #: 280
EMC 7763 K. Schwarz Vol #: 280
EMC 7764 L. Brunner Vol #: 280
EMC 7765 C. Hart Vol #: 280
EMC 7766 M. A. Mead Vol #: 280
EMC 7767 J. Chandler Vol #: 280
EMC 7768 L. Sommer Vol #: 280
EMC 7769 N. Edwards Vol #: 280
EMC 7770 Dr. S. Cosgrove Vol #: 280
EMC 7771 M. C. Atwood Vol #: 280
EMC 7772 E. Bittel Vol #: 280
EMC 7773 C. Montemayor Vol #: 280
EMC 7774 A. Chisolm Vol #: 280
EMC 7775 I. Fosse Vol #: 280
EMC 7776 C. Goddwin Vol #: 280
EMC 7777 R. W. Schultz Vol #: 280
EMC 7778 L. Robinson Vol #: 280
2002E-0019 Patent Term Application for Axert No. 5,565,447
LET 5 U.S. Patent & Trademark Office Vol #: 1
2002E-0339 Benicar, U.S. Patent No. 5,616,599
LET 5 U.S. Patent & Trademark Office Vol #: 1
2003E-0033 Patent Extension Application for DERMAGRAFT No. 4,963,489
LET 3 U.S. Patent & Trademark Office Vol #: 1
2003E-0247 Patent Extension for Campath (Alemtuzumab), 5,545,403
NEC 1 FDA Vol #: 1
2004D-0160 Use of Unapproved Hormone Implants in Veal Calves
NWL 1 FDA Vol #: 1
2004E-0023 Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
LET 3 U.S. Patent & Trademark Office Vol #: 1
2004E-0040 Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
LET 3 U.S. Patent & Trademark Office Vol #: 1
2004E-0307 Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
APP 1
Continued
Eli Lilly and Company Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004E-0308 Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
APP 1 Q-MED AB Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004E-0314 Patent Extension for Spiriva HandiHaler (tiotropium bromide inhalation powder), U.S. Patent No. 5,610,163
APP 1 Boehringer Ingelheim KG Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004E-0316 Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943
APP 1 Ferrer Internacional, S.A. Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004E-0319 Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
APP 1 Pharmacia Corporation of Pfizer Inc. Vol #: 1
LET 1 U.S. Patent & Trademark Office Vol #: 1
2004N-0081 BSE Risk Materials in Foods and Cosmetics
BKG 1 Background Information Refs 1-63 Vol #: 2
EA 1 Environmental Assessment Vol #: 1
FONS 1 Finding of No Significant Impact Vol #: 1
NIR 1 FDA Vol #: 1
2004N-0257 Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
BKG 1 Background Material Refs 1-8 Vol #: 1
NPR 1 FDA Vol #: 1
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
NAP 1 FDA Vol #: 1
2004N-0279 Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
NM 1 FDA Vol #: 1
2004N-0291 Risk Assessment for Cosmetics and Potential Contamination with Bovine Spongiform Encephalopathy Agent
NAD 1 FDA Vol #: 1
RA 1 Risk Assessment Vol #: 1
2004P-0315 Switch Pseudoephedrine from Over the Counter (OTC) Sales
ACK 1 HFA-305 to Pharmacists Planning Service, Inc. (PPSI) Vol #: 1
CP 1
Pharmacists Planning Service, Inc. (PPSI) Vol #: 1
2004P-0320 Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
ACK 1 HFA-305 to Abbott Laboratories Vol #: 1
CP 1 Abbott Laboratories Vol #: 1
2004V-0317 Laser Light Show
ACK 1 HFA-305 to Caliente Resort LLC Vol #: 1
VAR 1 Caliente Resort LLC Vol #: 1
2004V-0318 Laser Light Show
ACK 1 HFA-305 to Sun on the Beach Vol #: 1
VAR 1 Sun on the Beach Vol #: 1

Page created on July 16, 2004 dp

Page updated on August 3, 2004 jb

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