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DOCKETS ENTERED on 3/20/03
Docket Number - Title
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements *
98N-1109 Mercury Compounds in Drugs and Food *
00N-1484 Safety Reporting Requirements Human Drug/Biological Products *
02D-0137 Guidance Recommending Seizure & Destruction of Human/Animal *
02D-0492 Clinical Trials for Therapeutics in Adult Healthy Volunteers *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0534 Medical Device User Fee and Modernization Act of 2002 *
02P-0004 ANDA for Hydrocodone Bitartrate & Actaminophen *
03P-0107 Synthroid (levothyroxine sodium) Tablets (NDA 21-402) *
03P-0108 Permit ANADA for Apramycin Sulfate Soluble Powder *
03P-0109 Promulgate regulation mandating adverse reporting for dietar *
03P-0110 ANDA Suitability for Epirubicin Hydrochloride Injection *
80N-0280 Vaginal Contraceptive Drug Products for OTC Use
EC 130 Ms. kimberly krahn Vol#: 14
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
C 3770 Patricia Miller Vol#: 299
C 3771 Bonnie Kloepfer Vol#: 299
C 3772 JR Carlson Laboratories, Inc. Vol#: 299
C 3773 Larry Reitz Vol#: 299
C 3774 Sarah Doney Vol#: 299
C 3775 Kathy Vol#: 299
C 3776 Form Letters 11 Vol#: 308
EC 292 Individual Vol#: 307
EC 293 Mr. Steve Shuch Vol#: 307
EC 294 Mr. Steve Shuch Vol#: 307
EC 295 Mr. Mark McLeod Vol#: 307
EC 296 ADL WELLNESS & HERBS N' MORE, INC Vol#: 307
EC 297 Human Muscle & Perfomance Magazine Vol#: 307
EC 298 Mr. Robert Doherty Vol#: 307
EC 299 Ms. Annie Valadares Vol#: 307
EC 300 Individual Vol#: 307
EC 301 Nature's Life Vol#: 307
EC 302 Goen Technologies Vol#: 307
EC 303 Mrs. Betty Martin Vol#: 307
EC 304 Mr. Dwayne Martin Vol#: 307
EC 305 University of Arizona Health Sciences Ce Vol#: 307
EC 306 Ms. Marina Zakala Vol#: 307
EC 307 Mr. Don Dye Vol#: 307
EC 308 Mrs. Martha Hafen Vol#: 307
EC 309 Mr. Gary Ernst Vol#: 307
EC 310 Ms. JANET HOLYOAK Vol#: 307
EC 311 Mr. Gary Westrick Vol#: 307
EC 312 HEALTHY ALTERNATIVES INC Vol#: 307
EC 313 Shehzhen Qianrenren Sci. & Tech. Develop Vol#: 307
EC 314 Ms. tera hausmann Vol#: 307
EC 315 Natural Balance Vol#: 307
EC 316 National Capital Wellness Vol#: 307
EC 317 Accelerated Weight Loss Vol#: 307
EC 318 E'OLA INTERNATIONAL DISTRIBUTOR Vol#: 307
EC 319 Number Not Used Vol#: 307
EC 320 E'ola International Vol#: 307
EC 321 Dr. steve parcell Vol#: 307
EC 322 Mile High Muscle, LLC Vol#: 307
EC 323 Mr. Sam Maynard Vol#: 307
EC 324 Mrs. Diana Navas Vol#: 307
EC 325 Mrs. Laura Grosshans Vol#: 307
EC 326 Arama Enterprises Vol#: 307
EC 327 Wellness International Network Vol#: 307
EC 328 Mrs. Nita Diehl Vol#: 307
EC 329 Mr. James Xu Vol#: 307
EC 330 Nature's Pantry Vol#: 307
EC 331 Healthy Alternatives, Inc. Vol#: 307
EC 332 Dr. Albert Fleischner Vol#: 307
EC 333 Mrs. SUSAN LOHSE Vol#: 307
EC 334 Mrs. Patricia Rishebarger Vol#: 307
EC 335 Feel Better Group, LLC Vol#: 307
EC 336 Dr. SURESH ARORA Vol#: 307
EC 337 Mr. Martin Peters Vol#: 307
EC 338 J & N Life Fuel, Inc. Vol#: 307
EC 339 Mr. Christopher Williams Vol#: 307
EC 340 Argus Professional Services Vol#: 307
EC 341 Ms. Vicki Bujny Vol#: 307
EC 342 Miss Nakeya Barreto Vol#: 307
EC 343 Mrs. Geni Henthorn Vol#: 307
EC 344 SUNY Stony Brook University Vol#: 307
EC 345 NONE Vol#: 307
EC 346 Bastyr University Vol#: 307
EC 347 Pioneer Nutritional Formulas, Inc. Vol#: 307
EC 348 Pioneer Nutritional Formulas, Inc. Vol#: 307
EC 349 Mr. Richard Bahmann Vol#: 307
EC 350 Pioneer Nutritional Formulas Vol#: 307
EC 351 Wellness int network Vol#: 307
EC 352 Environments Plus Vol#: 307
EC 353 Columbia River Health and Fitness Vol#: 307
EC 354 NUTRITION CENTER Vol#: 307
EC 355 NUTRITION CENTER Vol#: 307
EC 356 The Vitamin Emporium Vol#: 307
EC 357 Northcoast Cooperative, Inc Vol#: 307
EC 358 SuperNutrition Vitamins Vol#: 307
EC 359 goen technologies Vol#: 307
EC 360 Goen Technologies Vol#: 307
EC 361 Mr. Russell Stanley Vol#: 307
EC 362 Natural Edge Hawaii, Inc. Vol#: 307
EC 363 Health Freedom Nutrition LLC Vol#: 307
EC 364 Apothecarian Herbals, LLC Vol#: 307
EC 365 bingertabs.com Vol#: 307
EC 366 Wellness Marketing Group Vol#: 307
EC 367 Law Offices of Christopher E. Grell Vol#: 307
EC 368 Ra-Zen Releif, Inc. Vol#: 307
EC 369 Nuts N Berries Vol#: 307
EC 370 nature for your bod Vol#: 307
EC 371 Amber Technology Vol#: 307
96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
C 100 National Organization for Rare Disorders Vol#: 7
EC 4 Dr. steve parcell Vol#: 7
98N-1109 Mercury Compounds in Drugs and Food
C 9 Wyeth Pharmaceuticals Vol#: 2
00N-1484 Safety Reporting Requirements Human Drug/Biological Products
02D-0137 Guidance Recommending Seizure & Destruction of Human/Animal
C 3 National Food Processors Assn (NFPA) Vol#: 1
02D-0385 Approval of Labeling for Foods Treated by Irradiation
C 13 Jennifer Adams Vol#: 1
02D-0492 Clinical Trials for Therapeutics in Adult Healthy Volunteers
C 10 Pharma Bio-Research Group BV Vol#: 1
02N-0204 Bar Code Label Requirements for human drug products
BKG 1 BACKGROUND Vol#: 8
C 24 South Dakota Board of Pharmacy Vol#: 6
EC 7 FRC Blood Transfusion Service Vol#: 6
EC 9 Allermed Laboratories, Inc. Vol#: 6
EC 10 N/A Vol#: 6
EC 11 Geisinger Health System Vol#: 6
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities
EC 68 Tequila Regulatory Council Vol#: 7
EC 69 Brazilian Embassy Vol#: 7
EC 70 GODWIN AUSTEN INTERNATIONAL LTD - Jakart Vol#: 7
EC 71 Yeo Hiap Seng (Malaysia) Berhad Vol#: 7
EC 72 Brewers Association of Canada Vol#: 7
02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
EC 69 Number Not Used Vol#: 7
EC 70 Icelandic Consulate in New York Vol#: 7
EC 71 Enaca International, LLC Vol#: 7
EC 72 Brewers Association of Canada Vol#: 7
EC 73 H & N Foods International Vol#: 7
02N-0534 Medical Device User Fee and Modernization Act of 2002
C 16 Assn of Medical Device Reprocessors Vol#: 1
C 17 Assn of Medical Device Reprocessors Vol#: 1
C 18 Alliance Medical Corporation Vol#: 1
C 19 Alliance Medical Corporation Vol#: 1
02P-0004 ANDA for Hydrocodone Bitartrate & Actaminophen
PDN 1 HFD-600 to Ambi Pharmaceuticals, Inc. Vol#: 1
03N-0034 FDA Safety Alert/ Public Health Advisory Readership Survey
EC 4 Number Not Used Vol#: 1
03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
EC 15 Cipla ltd Vol#: 1
03N-0069 FDA Task Force on Consumer Health Info for Better Nutrition
EC 4 Ms. Viola Smith Vol#: 1
EC 5 Number Not Used Vol#: 1
EC 6 Shen Men Feng Shui Vol#: 1
EC 7 Number Not Used Vol#: 1
EC 8 Number Not Used Vol#: 1
03P-0107 Synthroid (levothyroxine sodium) Tablets (NDA 21-402)
ACK 1 HFA-305 Vol#: 1
CP 1 Mylan Pharmaceuticals Inc. Vol#: 1
03P-0108 Permit ANADA for Apramycin Sulfate Soluble Powder
ACK 1 HFA-305 Vol#: 1
CP 1 Cross Vetpharm Group, Ltd. Vol#: 1
03P-0109 Promulgate regulation mandating adverse reporting for dietar
ACK 1 HFA-305 to American Herbal Products Assn Vol#: 1
CP 1 American Herbal Products Assn. Vol#: 1
03P-0110 ANDA Suitability for Epirubicin Hydrochloride Injection
ACK 1 HFA-305 Vol#: 1