|
|
|
FDA Home Page | Search
FDA Site | A-Z Index | Contact
FDA
Dockets Entered On June 09, 2003 TABLE OF CONTENTS (Linked) | ||||||||||||
| Docket # | Title | |||||||||||
| 1975N-0069 | RADIOACTIVE DRUGS, INCLUDING BIOLOGICAL PRODUCTS | |||||||||||
| 1978N-0038 | Sunscreen Drug Products | |||||||||||
| 1999D-5047 | Industry on Pharmacokinetics in Patients with Impaired Hepat | |||||||||||
| 2002N-0528 | Risk Management Workshop, April 9-11, 2003 [PDUFA III] | |||||||||||
| 2002P-0357 | Stay Effective Date of Compliance for Monograph Title Change | |||||||||||
| 2003D-0044 | Reporting Results for Studies Evaluating Diagnostic Tests | |||||||||||
| 2003D-0186 | Guidance for Industry: Use of Material From Deer and Elk In Animal Feed | |||||||||||
| 2003N-0069 | FDA Task Force on Consumer Health Info for Better Nutrition | |||||||||||
| 2003N-0158 | Specification for Annotated Electrocardiographic Waveform | |||||||||||
| 2003N-0169 | Dental Amalgam; Request for Information | |||||||||||
| 2003N-0200 | Agency Information
Collection Activities: Proposed Collection; Comment Request; Export of Medical
Devices ? Foreign Letters of Approval | |||||||||||
| 2003P-0105 | Revoke Medical Device Tracking Order | |||||||||||
| 2003P-0258 | Carotenoid astaxanthin to have the label " color added" or artificial color | |||||||||||
| CONTENTS | ||||||||||||
| 1975N-0069 | RADIOACTIVE DRUGS, INCLUDING BIOLOGICAL PRODUCTS | |||||||||||
| EXT 1 | American Colletge of Nuclear Physicians | Vol #: | 1 | |||||||||
| 1978N-0038 | Sunscreen Drug Products | |||||||||||
| PDN 2 | HF-22 to Cosmetic, Toiletry and Fragrance Association | Vol #: | 147 | Enclosures | ||||||||
| 1986V-0378 | LASER MEDIA; LM TABLE & LMS TABLE | |||||||||||
| VRA 8 | HFZ-300 to Lasertech | Vol #: | 1 | ||||||
| 1991V-0150 | Laser light show | ||||||||
| VRA 6 | HFZ-300 to Y L S Productions | Vol #: | 1 | ||||||
| 1992V-0074 | Variance for Laser Light Show | ||||||||
| VRA 5 | HFZ-300 to Science Center of Iowa | Vol #: | 1 | ||||||
| 1996V-0138 | Laser Light Show | ||||||||
| VRA 5 | HFZ-300 to Strictly FX, LLC | Vol #: | 1 | ||||||
| 1999D-5047 | Industry on Pharmacokinetics in Patients with Impaired Hepat | ||||||||
| GDL 2 | Guidance | Vol #: | 1 | ||||||
| NAD 2 | FDA | Vol #: | 1 | ||||||
| 2002N-0528 | Risk Management Workshop, April 9-11, 2003 [PDUFA III] | ||||||||
| C 14 | Wyeth Pharmaceuticals | Vol #: | 7 | ||||||
| 2002P-0357 | Stay Effective Date of Compliance for Monograph Title Change | ||||||||
| PAV 1 | HF-22 to Bayer Corporation | Vol #: | 1 | ||||||
| 2002P-0447 | Immediately revoke its acceptance for NDA 21-435 for amlodin | ||||||||
| SUP 1 | Venable, Baetjer, Howard & Civiletti, LLP | Vol #: | 1 | Tab A Tab B Tab C | |||||
| 2003D-0044 | Reporting Results for Studies Evaluating Diagnostic Tests | ||||||||
| C 4 | University of Washington | Vol #: | 1 | ||||||
| C 5 | Abbott Laboratories | Vol #: | 1 | ||||||
| 2003D-0186 | Guidance for Industry: Use of Material From Deer and Elk In Animal Feed | ||||||||
| EMC 1 | Terry S. Singeltary Sr. | Vol #: | 1 | ||||||
| EMC 2 | Indiana Department of Natural Resources | Vol #: | 1 | ||||||
| 2003E-0254 | Patent Extension for Inspra (eplerenone), 4,559,332 | ||||||||
| APP 1 | Pharmacia Corporation | Vol #: | 1 | ||||||
| LET 1 | U S Patent and Trademark Office | Vol #: | 1 | ||||||
| 2003E-0255 | Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932 | ||||||||
| APP 1 | Eli Lilly and Company | Vol #: | 1 | ||||||
| LET 1 | U S Patent and Trademark Office | Vol #: | 1 | ||||||
| 2003E-0256 | Patent Extension for Ranexa (ranolazine), 4,567,264 | ||||||||
| APP 1 | Roche Palo Alto LLC | Vol #: | 1 | ||||||
| LET 1 | U S Patent and Trademark Office | Vol #: | 1 | ||||||
| 2003E-0257 | Patent Extension for Neotame, 5,480,668 | ||||||||
| APP 1 | NutraSweet Company | Vol #: | 1 | ||||||
| LET 1 | U S Patent and Trademark Office | Vol #: | 1 | ||||||
| LET 2 | U S Patent and Trademark Office | Vol #: | 1 | ||||||
| 2003E-0259 | Patent Extension Extension for Geodon or Zeldox (ziprasidone HCl monohydrate), 4,831,031 | ||||||||
| APP 1 | Pfizer Inc. | Vol #: | 1 | ||||||
| LET 1 | U S Patent and Trademark Office | Vol #: | 1 | ||||||
| 2003E-0260 | Patent Extension for Amevive (alefacept), 5,547,853 | ||||||||
| APP 1 | Fish & Richardson PC | Vol #: | 1 | ||||||
| LET 1 | U S Patent and Trademark Office | Vol #: | 1 | ||||||
| 2003E-0261 | Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590 | ||||||||
| APP 1 | Eli Lilly and Company | Vol #: | 1 | ||||||
| LET 1 | U S Patent and Trademark Office | Vol #: | 1 | ||||||
| 2003N-0069 | FDA Task Force on Consumer Health Info for Better Nutrition | ||||||||
| EMC 4 | Consumer Healthcare Products Assn & Council for Responsible Nutrition | Vol #: | 1 | ||||||
| EMC 5 | Council for Responsible Nutrition | Vol #: | 1 | ||||||
| EMC 6 | Wheat Foods Council (WFC) & American Bakers Assn (ABA) | Vol #: | 1 | ||||||
| EMC 7 | AARP | Vol #: | 1 | ||||||
| EMC 8 | Honorable Henry A. Waxman et. al | Vol #: | 1 | ||||||
| 2003N-0158 | Specification for Annotated Electrocardiographic Waveform | ||||||||
| EMC 1 | AstraZeneca R&D | Vol #: | 1 | ||||||
| EMC 2 | National electrical Manufacturers Assn | Vol #: | 1 | ||||||
| EMC 3 | Merck & Co., Inc. | Vol #: | 1 | ||||||
| EMC 4 | General electric Medical Systems Information Technologies | Vol #: | 1 | ||||||
| 2003N-0169 | Dental Amalgam; Request for Information | ||||||||
| EMC 1 | No signature | Vol #: | 2 | ||||||
| EMC 2 | Michael W. Davis, DDS | Vol #: | 2 | ||||||
| EMC 3 | Steve Markus | Vol #: | 2 | ||||||
| EMC 4 | Pat King | Vol #: | 2 | |||||
| EMC 5 | Nancy Richards | Vol #: | 2 | |||||
| EMC 6 | L. Campbell | Vol #: | 2 | |||||
| EMC 7 | David C. Kennedy, DDS | Vol #: | 2 | |||||
| EMC 8 | DAMS | Vol #: | 2 | |||||
| EMC 9 | DAMS | Vol #: | 2 | |||||
| EMC 10 | DAMS | Vol #: | 2 | |||||
| EMC 11 | DAMS | Vol #: | 2 | |||||
| EMC 12 | DAMS | Vol #: | 2 | |||||
| EMC 13 | DAMS | Vol #: | 2 | |||||
| EMC 14 | DAMS | Vol #: | 2 | |||||
| EMC 15 | DAMS | Vol #: | 2 | |||||
| EMC 16 | DAMS | Vol #: | 2 | |||||
| EMC 17 | DAMS | Vol #: | 2 | |||||
| EMC 18 | DAMS | Vol #: | 2 | |||||
| EMC 19 | DAMS | Vol #: | 2 | |||||
| EMC 20 | DAMS | Vol #: | 2 | |||||
| EMC 21 | DAMS | Vol #: | 2 | |||||
| EMC 22 | Freya Koss | Vol #: | 2 | |||||
| EMC 23 | Freya Koss | Vol #: | 2 | |||||
| EMC 24 | Freya Koss | Vol #: | 2 | |||||
| EMC 25 | Freya Koss | Vol #: | 2 | |||||
| EMC 26 | Freya Koss | Vol #: | 2 | |||||
| EMC 27 | Lois Nowak | Vol #: | 2 | |||||
| EMC 28 | Lois Nowak | Vol #: | 2 | |||||
| EMC 29 | Lois Nowak | Vol #: | 2 | |||||
| EMC 30 | Lois Nowak | Vol #: | 2 | |||||
| EMC 31 | Lois Nowak | Vol #: | 2 | |||||
| EMC 32 | Lois Nowak | Vol #: | 2 | |||||
| EMC 33 | Lois Nowak | Vol #: | 2 | |||||
| EMC 34 | Halny Wiatr | Vol #: | 2 | |||||
| EMC 35 | Gerald H. Smith, DDS | Vol #: | 2 | |||||
| EMC 36 | Freya Koss | Vol #: | 2 | |||||
| EMC 37 | Freya Koss | Vol #: | 2 | |||||
| EMC 38 | Freya Koss | Vol #: | 2 | |||||
| EMC 39 | Freya Koss | Vol #: | 2 | |||||
| EMC 40 | Freya Koss | Vol #: | 2 | |||||
| EMC 41 | Freya Koss | Vol #: | 2 | |||||
| EMC 42 | Freya Koss | Vol #: | 2 | |||||
| EMC 43 | Freya Koss | Vol #: | 2 | |||||
| EMC 44 | Freya Koss | Vol #: | 2 | |||||
| EMC 45 | DAMS | Vol #: | 2 | |||||
| EMC 46 | DAMS | Vol #: | 2 | |||||
| EMC 47 | DAMS | Vol #: | 2 | |||||
| EMC 48 | DAMS | Vol #: | 2 | |||||
| EMC 49 | DAMS | Vol #: | 2 | |||||
| EMC 50 | DAMS | Vol #: | 2 | |||||
| EMC 51 | Claire Wachter, DMA | Vol #: | 2 | |||||
| EMC 52 | Marilyn Carter | Vol #: | 2 | |||||
| EMC 53 | Jerry & Karen Snyder | Vol #: | 2 | |||||
| EMC 54 | Consumers for Dental Choice | Vol #: | 2 | |||||
| EMC 55 | No signature | Vol #: | 2 | |||||
| EMC 56 | Marie Flowers | Vol #: | 2 | |||||
| EMC 57 | Marie Flowers | Vol #: | 2 | |||||
| EMC 58 | Marie Flowers | Vol #: | 2 | |||||
| EMC 59 | Marie Flowers | Vol #: | 2 | |||||
| EMC 60 | Marie Flowers | Vol #: | 2 | |||||
| EMC 61 | Marie Flowers | Vol #: | 2 | |||||
| EMC 62 | Marie Flowers | Vol #: | 2 | |||||
| EMC 63 | Marie Flowers | Vol #: | 2 | |||||
| EMC 64 | Marie Flowers | Vol #: | 2 | |||||
| EMC 65 | Marie Flowers | Vol #: | 2 | |||||
| EMC 66 | Marie Flowers | Vol #: | 2 | |||||
| EMC 67 | Marie Flowers | Vol #: | 2 | |||||
| EMC 68 | Marie Flowers | Vol #: | 2 | |||||
| EMC 69 | Marie Flowers | Vol #: | 2 | |||||
| EMC 70 | Marie Flowers | Vol #: | 2 | |||||
| EMC 71 | Marie Flowers | Vol #: | 2 | |||||
| EMC 72 | Marie Flowers | Vol #: | 2 | |||||
| EMC 73 | Marie Flowers | Vol #: | 2 | |||||
| EMC 74 | Marie Flowers | Vol #: | 2 | |||||
| EMC 75 | Marie Flowers | Vol #: | 2 | |||||
| EMC 76 | Marie Flowers | Vol #: | 2 | |||||
| EMC 77 | Marie Flowers | Vol #: | 2 | |||||
| EMC 78 | Marie Flowers | Vol #: | 2 | |||||
| EMC 79 | Marie Flowers | Vol #: | 2 | |||||
| EMC 80 | Marie Flowers | Vol #: | 2 | |||||
| EMC 81 | Marie Flowers | Vol #: | 2 | |||||
| EMC 82 | Marie Flowers | Vol #: | 2 | |||||
| EMC 83 | Marie Flowers | Vol #: | 2 | |||||
| EMC 84 | Marie Flowers | Vol #: | 2 | |||||
| EMC 85 | Marie Flowers | Vol #: | 2 | |||||
| EMC 86 | Marie Flowers | Vol #: | 2 | |||||
| EMC 87 | Marie Flowers | Vol #: | 2 | |||||
| EMC 88 | Marie Flowers | Vol #: | 2 | |||||
| EMC 89 | Clinton Zimmerman | Vol #: | 2 | |||||
| EMC 90 | DAMS | Vol #: | 2 | |||||
| EMC 91 | DAMS | Vol #: | 2 | |||||
| EMC 92 | DAMS | Vol #: | 2 | |||||
| EMC 93 | DAMS | Vol #: | 2 | |||||
| EMC 94 | DAMS | Vol #: | 2 | |||||
| EMC 95 | DAMS | Vol #: | 2 | |||||
| EMC 96 | DAMS | Vol #: | 2 | |||||
| EMC 97 | DAMS | Vol #: | 2 | |||||
| EMC 98 | DAMS | Vol #: | 2 | |||||
| EMC 99 | DAMS | Vol #: | 2 | |||||
| EMC 100 | DAMS | Vol #: | 2 | |||||
| EMC 101 | Mary Ann Newell | Vol #: | 2 | |||||
| EMC 102 | Mary Ann Newell | Vol #: | 2 | |||||
| EMC 103 | Mary Ann Newell | Vol #: | 2 | |||||
| EMC 104 | Mary Ann Newell | Vol #: | 2 | |||||
| EMC 105 | Paul G. Rubin, DDS | Vol #: | 2 | |||||
| EMC 106 | Connecticut State dental Assn (CSDA) | Vol #: | 2 | |||||
| EMC 107 | Mats Hanson, PhD | Vol #: | 2 | |||||
| EMC 108 | Stuart Scheckner | Vol #: | 2 | |||||
| EMC 109 | Marie Flowers | Vol #: | 2 | |||||
| EMC 110 | Marie Flowers | Vol #: | 2 | |||||
| EMC 111 | Marie Flowers | Vol #: | 2 | |||||
| EMC 112 | Marie Flowers | Vol #: | 2 | |||||
| EMC 113 | Marie Flowers | Vol #: | 2 | |||||
| EMC 114 | Marie Flowers | Vol #: | 2 | |||||
| EMC 115 | Marie Flowers | Vol #: | 2 | ||||||
| EMC 116 | Paul Moller | Vol #: | 2 | ||||||
| EMC 117 | Marie Flowers | Vol #: | 2 | ||||||
| EMC 118 | Marie Flowers | Vol #: | 2 | ||||||
| EMC 119 | Marie Flowers | Vol #: | 2 | ||||||
| EMC 120 | Marie Flowers | Vol #: | 2 | ||||||
| EMC 121 | Marie Flowers | Vol #: | 2 | ||||||
| EMC 122 | Maryanne Rygg | Vol #: | 2 | ||||||
| EMC 123 | James E. Hardy, DMD | Vol #: | 2 | ||||||
| EMC 124 | Dwight Florence | Vol #: | 2 | ||||||
| EMC 125 | Leslie Joy Smith | Vol #: | 2 | ||||||
| EMC 126 | Ann Meyer | Vol #: | 2 | ||||||
| EMC 127 | Louisiana Dental Assn (LDA) | Vol #: | 2 | ||||||
| EMC 128 | Lyle Brown | Vol #: | 2 | ||||||
| 2003N-0200 | Agency Information Collection
Activities: Proposed Collection; Comment Request; Export of Medical Devices
? Foreign Letters of Approval | ||||||||
| N 1 | FDA | Vol #: | 1 | ||||||
| 2003P-0105 | Revoke Medical Device Tracking Order | ||||||||
| WDL 1 | Mettler Electronics Corp. | Vol #: | 1 | ||||||
| 2003P-0258 | Carotenoid astaxanthin to have the label " color added" or artificial color | ||||||||
| ACK 1 | HFA-305 To Erick Swanson | Vol #: | 1 | ||||||
| CP 1 | Erick Swanson | Vol #: | 1 | ||||||
| 2003V-0185 | Laser Light Show | ||||||||
| VRA 1 | HFZ-300 to Creative Consultants, LLC | Vol #: | 1 | ||||||
| 2003V-0192 | Laser Light Show | ||||||||
| VRA 1 | HFZ-300 to Fun Factory Mobile DJs | Vol #: | 1 | ||||||
| 2003V-0230 | Laser Light Show | ||||||||
| ACK 1 | HFA-305 | Vol #: | 1 | ||||||
Page Updated August 12, 2003;rm
Dockets Home | Accessibility | Dockets Contacts and Location | Operating Status | Item Codes