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Dockets Entered On June 10, 2003 TABLE OF CONTENTS (Linked) | ||||||||||||
| Docket # | Title | |||||||||||
| 1978N-0064 | OTC Antiperspirant | |||||||||||
| 1995N-0304 | Ephedrine Alkaloids: Reports of Adverse Events; Availability | |||||||||||
| 1995S-0158 | Community Disclosure of Institutional Review Boards | |||||||||||
| 1996N-0417 | CGMP in Mfg. Packing or Holding Dietary Supplements | |||||||||||
| 2000N-1571 | Enrofloxacin for Poultry: Opportunity for Hearing | |||||||||||
| 2002N-0204 | Bar Code Label Requirements for human drug products | |||||||||||
| 2002N-0417 | Applications for FDA Approval to Market a New Drug | |||||||||||
| 2002N-0418 | Adverse Experience Reporting for Licensed Biological Produts; Agency Information Collection Activities | |||||||||||
| 2002N-0475 | Financial Relationships & Interest in Research Involving Hum | |||||||||||
| 2002P-0256 | Determine if ANDA 76-122 is Entitled to 180 Days Exclusivity | |||||||||||
| 2002P-0478 | Fentanyl transdermal system 12.5 mcg/hr is suitable for ANDA | |||||||||||
| 2003N-0068 | Beverages: Bottled Water | |||||||||||
| 2003N-0169 | Dental Amalgam; Request for Information | |||||||||||
| 2003P-0029 | Remove metered-dose inhalers (MDI) containing moiety albuter | |||||||||||
| CONTENTS | ||||||||||||
| 1978N-0064 | OTC Antiperspirant | |||||||||||
| GDL 2 | Guidelines for Effectiveness Testing of OTC Antiperspirant Drug Products | Vol #: | 51 | |||||||||
| NFR 1 | FDA | Vol #: | 51 | |||||||||
| 1995N-0304 | Ephedrine Alkaloids: Reports of Adverse Events; Availability | |||||||||||
| C 4030 | Representative Dan Burton | Vol #: | 374 | |||||||||
| C 4031 | Veterinary Botanical Medicine Assn | Vol #: | 374 | |||||||||
| 1995S-0158 | Community Disclosure of Institutional Review Boards | |||||||||||
| RPT 10 | University of Pittsburgh | Vol #: | 5 | |||||||||
| 1996N-0417 | CGMP in Mfg. Packing or Holding Dietary Supplements | |||||||||||
| C 115 | Form Letters | Vol #: | 18 | |||||||||
| C 116 | Gaia Herbs, Inc. | Vol #: | 17 | |||||||||
| C 117 | The Korner Pharmacy | Vol #: | 17 | |||||||||
| 1998P-0151 | Introduction Of Downed Cattle Into The Food Supply | |||||||||||
| C 6487 | Tanya Weathersby | Vol #: | 276 | |||||||||
| C 6488 | Jenny Bramlette | Vol #: | 276 | |||||||||
| C 6489 | Lori Williamson | Vol #: | 276 | ||||||
| C 6490 | Janae' Jackson | Vol #: | 276 | ||||||
| C 6491 | Donna Worthington | Vol #: | 276 | ||||||
| C 6492 | Ms. Shirley Whisman | Vol #: | 276 | ||||||
| C 6493 | Mary Martin Loder, Ph.D. | Vol #: | 276 | ||||||
| C 6494 | Tiffany Story | Vol #: | 276 | ||||||
| C 6495 | Lynda Ream | Vol #: | 276 | ||||||
| C 6496 | Ashley Hannan | Vol #: | 276 | ||||||
| C 6497 | Mrs. Audrey S. Fitchett | Vol #: | 276 | ||||||
| C 6498 | Ruth England | Vol #: | 276 | ||||||
| C 6499 | Joan H. Alliger | Vol #: | 276 | ||||||
| C 6500 | Ms. Teresa Tyler | Vol #: | 276 | ||||||
| C 6501 | Wayne MacNerland | Vol #: | 276 | ||||||
| C 6502 | Eva MacNerland | Vol #: | 276 | ||||||
| 2000N-1571 | Enrofloxacin for Poultry: Opportunity for Hearing | ||||||||
| LET 14 | Center for Veterinary Medicine | Vol #: | 378 | ||||||
| 2001P-0075 | Switch Status of Emergency Contraceptives from Rx to OTC | ||||||||
| C 289 | Grother Tom Gurlie | Vol #: | 38 | ||||||
| 2002N-0204 | Bar Code Label Requirements for human drug products | ||||||||
| C 48 | Webscan, Inc. | Vol #: | 13 | ||||||
| C 49 | Wolter Kluwer Health | Vol #: | 13 | ||||||
| 2002N-0277 | Bioterrorism; Establishment & Maintenance of Records | ||||||||
| C 29 | Blue Diamond Growers | Vol #: | 4 | ||||||
| C 30 | Ross Consulting, LLC | Vol #: | 4 | ||||||
| EC 32 | Karches, Don | Vol #: | 0 | ||||||
| 2002N-0417 | Applications for FDA Approval to Market a New Drug | ||||||||
| C 33 | Alphapharm Pty Ltd | Vol #: | 4 | ||||||
| 2002N-0418 | Adverse Experience Reporting for Licensed Biological Produts; Agency Information Collection Activities | ||||||||
| NAL 1 | FDA | Vol #: | 1 | ||||||
| SS 1 | Supporting Statement | Vol #: | 1 | ||||||
| 2002N-0475 | Financial Relationships & Interest in Research Involving Hum | ||||||||
| C 20 | Chesapeake Research Review, Inc. | Vol #: | 2 | ||||||
| C 21 | Assocation of Clinical Research Professionals | Vol #: | 2 | ||||||
| C 22 | University of Pittsburgh | Vol #: | 2 | ||||||
| C 23 | Federation of American Societies for Experimental Biology | Vol #: | 2 | ||||||
| C 24 | University of North Carolina At Chapel Hill | Vol #: | 2 | ||||||
| C 25 | The Rockefeller University | Vol #: | 2 | ||||||
| C 26 | Association of American Universities | Vol #: | 2 | ||||||
| C 27 | University of California, Berkeley | Vol #: | 2 | ||||||
| C 28 | Indiana University | Vol #: | 2 | ||||||
| C 29 | Council on Governmental Relations | Vol #: | 2 | ||||||
| C 30 | Case Western Reserve University | Vol #: | 2 | ||||||
| C 31 | Cornell University | Vol #: | 2 | ||||||
| 2002P-0256 | Determine if ANDA 76-122 is Entitled to 180 Days Exclusivity | ||||||||
| LET 1 | Mylan Laboratories, Inc. | Vol #: | 1 | ||||||
| 2002P-0478 | Fentanyl transdermal system 12.5 mcg/hr is suitable for ANDA | ||||||||
| C 2 | Alza Corporation | Vol #: | 1 | ||||||
| 2003N-0068 | Beverages: Bottled Water | ||||||||
| NCD 1 | FDA | Vol #: | 1 | ||||||
| 2003N-0169 | Dental Amalgam; Request for Information | ||||||||
| C 3 | Maine Dental Assn | Vol #: | 1 | ||||||
| C 4 | American Dental Education Assn (ADEA) | Vol #: | 1 | ||||||
| SUP 4 | Mark Thorson | Vol #: | 1 | ||||||
| 2003P-0029 | Remove metered-dose inhalers (MDI) containing moiety albuter | ||||||||
| C 2 | Buchanan Ingersoll | Vol #: | 1 | ||||||
Page Updated August 12, 2003:rm