Food and Drug AdministrationDockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on August 30, 2000

TABLE OF CONTENTS

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[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1431 ANDA for elixir containing 10mg hydrocodone bitartrate/650mg *
00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

APE 27 United States Air Force Vol#: 65

APE 28 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 29 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 30 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 31 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 32 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 33 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 34 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 35 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 36 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 37 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 38 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 39 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 40 Arthur M. Schlyer, M.D. Vol#: 65

APE 41 Omnitrition Intl., Inc. Vol#: 65

APE 42 Alan Feldstein, Starlight Intl. Ltd. Vol#: 65

APE 43 Lauren Mitchell Vol#: 65

APE 44 Citifinancial, Inc. Vol#: 65

APE 45 Alliance Associates Vol#: 65

APE 46 Kimberly Jerrow Vol#: 65

APE 47 Gayla Heflin Vol#: 65

APE 48 Council on Size & Weight Discrimination Vol#: 65

APE 49 Practicina Physician & Surgcor Vol#: 65

APE 50 Res. Dept. of the Royal Vet Agr.Universi Vol#: 65

TR 1 Safety of Dietary Supplements Mtg. 8/8-9 Vol#: 66

TS 47 Ruth H. Strauss, M.D. Vol#: 65
 
 

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 599 Moorpark Family Care Center Vol#: 22

CH 600 Shirley Hayes Vol#: 22

CH 601 No Signature Vol#: 22

CH 602 Ethel Wilks Vol#: 22

CH 603 Mellissa Anne Waters Vol#: 22

CH 604 Leonard Dezelski Vol#: 22

CH 605 Jacqueline & Burton Muller Vol#: 22

CH 606 Mary G. Cole Vol#: 22

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

EXT 5 Regeneration Technologies, Inc. Vol#: 1

EXT 6 Medtronic Sofamor Danek Vol#: 1

EXT 7 AdvaMed Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 5150 Andrea B. Gerke Vol#: 198

C 5151 Patricia Baker Vol#: 198

C 5152 Julia Sennette Vol#: 198

C 5153 John Stevenson Vol#: 198

C 5154 Shirley Rast Vol#: 198

C 5155 Carol Foster Vol#: 198

C 5156 Peter B. Laughton Vol#: 198

C 5157 Timothy Teravainen Vol#: 198

C 5158 Maya Vol#: 198

C 5159 Brion M. Wallis Vol#: 198

C 5160 Carol Ashley Vol#: 198

C 5161 Andrew Hayes Vol#: 198

C 5162 Jerry Modugno Vol#: 198

C 5163 David Eliscu Vol#: 198

C 5164 Mrs. Rubert Petrarca Vol#: 198

C 5165 Reginald Forbes Vol#: 198

C 5166 Ann Crowley Vol#: 198

C 5167 Robert Kuljis Vol#: 198

C 5168 Carole Ritenour Vol#: 198

C 5169 Amanda Rollins Vol#: 198

C 5170 Laima Danilovs Vol#: 198

C 5171 Theresa Sansom Vol#: 198

C 5172 Susan Kennedy Vol#: 198

C 5173 Christina Freeman Vol#: 198

C 5174 Hadenteldt Vol#: 198

C 5175 Patti McKee Vol#: 198

C 5176 E. A. Knauss Vol#: 198

C 5177 Amy Stoddard Vol#: 198

C 5178 Ken Loders Vol#: 198

C 5179 Chris Stehoik Vol#: 198

C 5180 Annette Garcher Vol#: 198

C 5181 Stan Mullins Vol#: 198

C 5182 James Ficklin Vol#: 198

C 5183 Frank Cusenzo Vol#: 198

C 5184 Ron Mink Vol#: 198

C 5185 Jessica Rose Funaro Vol#: 198

C 5186 Suzanne Frazier Vol#: 198

C 5187 Kathleen Klawiffer Vol#: 198

C 5188 Kathleen A. Rinaldi Vol#: 198

C 5189 Louise K. Grimes Vol#: 198

C 5190 Suzanne Mamat Vol#: 198

C 5191 Nancy K. Duncan Vol#: 198

C 5192 Konstanze L. Hickey Vol#: 198

C 5193 Jeff Alford Vol#: 198

C 5194 Angela Ornelas Vol#: 198

C 5195 Ms. Lee Mozena Vol#: 198

C 5196 Rene D. Ray Vol#: 198

C 5197 Caroline Parris Vol#: 198

C 5198 Joan Corliss Vol#: 198

C 5199 Megan Somers Vol#: 198

C 5200 Beverly Chinas Vol#: 198

C 5201 Glenn W. Hansens Vol#: 198

C 5202 Genevieve Laycock-Wallis Vol#: 198

C 5203 Melanie Moshier Vol#: 198

C 5204 Julie S. Barbour Vol#: 198

C 5205 Dorothy A. Mortiee Vol#: 198

C 5206 Susan H. King Vol#: 198

C 5207 Helen S. Geiger Vol#: 198

C 5208 Sharon Delap Vol#: 198

C 5209 Mark Coomes Vol#: 198

C 5210 Kurt Bodenbender Vol#: 198

C 5211 John Kress Vol#: 198

C 5212 Louis Feldman Vol#: 198

C 5213 Cauara Hamburg Vol#: 198

C 5214 Cleve Melatt Vol#: 198

C 5215 Kathryn E. Meyrovich Vol#: 198

C 5216 Lisa A. Biggs Vol#: 198

C 5217 Ellen Kane Vol#: 198

C 5218 Jeanette Ammon Vol#: 198

C 5219 Heather Sand Vol#: 198

C 5220 D. Forrest Johnson Vol#: 198

C 5221 J. S. Moir Vol#: 198

C 5222 Bernice Rezac Vol#: 198

C 5223 Sandra Stewart Vol#: 198

C 5224 Eve Robida Vol#: 198

C 5225 Ron & Corine Christman Vol#: 198

C 5226 Barbara Fletcher Vol#: 198

C 5227 Elizabeth Armstrong Vol#: 198

C 5228 Maegi Andreiko Vol#: 198

C 5229 Elisa Weller Vol#: 198

C 5230 Melissa Murray Vol#: 198

C 5231 Fred & Dorothy Solomon Vol#: 198

C 5232 Baredo Clark Vol#: 198

C 5233 Indigo Sutra Vol#: 198

C 5234 Sonia Macdonald Vol#: 198

C 5235 Ward Nickle Vol#: 198

C 5236 Dominique Bachelet Vol#: 198

C 5237 Constantine Fuller Vol#: 198

C 5238 Miriam Poston Vol#: 198

C 5239 Laura Houser Vol#: 198

C 5240 Cathy Mihally Vol#: 199

C 5241 Diane Lindeen Vol#: 199

C 5242 Carrie Thompson Vol#: 199

C 5243 Stephanie Keenan Vol#: 199

C 5244 Barbara Ristagno Vol#: 199

C 5245 Jean deSmes Vol#: 199

C 5246 Heather Sileo Vol#: 199

C 5247 Deon M. Painter Vol#: 199

C 5248 Doris Battersby Vol#: 199

C 5249 Edwin Schgarfer Vol#: 199

C 5250 Lisa Belisle Vol#: 199

C 5251 Kalanit Barson Vol#: 199

C 5252 Carmen Burgess Vol#: 199

C 5253 Maribeth C. Bowles Vol#: 199

C 5254 Susan von Ranson Vol#: 199

C 5255 Tenna E. Anderson Vol#: 199

C 5256 Suzette Tzineff Vol#: 199

C 5257 Rolf K. Taylor Vol#: 199

C 5258 Sky Mikinak Vol#: 199

C 5259 Jason W. Boyer Vol#: 199

C 5260 Carol Growden Vol#: 199

C 5261 Adam Tetebaum Vol#: 199

C 5262 Carol Raymond Vol#: 199

C 5263 Stephanie Penn Vol#: 199

C 5264 Jean Mayes Vol#: 199

C 5265 Jeremy Klapper Vol#: 199

C 5266 Giancarlo Licatz Vol#: 199

C 5267 Brenda DeWolf Vol#: 199

C 5268 Beverly Cox Vol#: 199

C 5269 Thelma D. Parham Vol#: 199

C 5270 Shirley Patterson Vol#: 199

C 5271 Leona H. Berry Vol#: 199

C 5272 Jean Rockhold Vol#: 199

C 5273 Mary Margaret Barr Vol#: 199

C 5274 Rowena Grice Jones Vol#: 199

C 5275 Frances Patton Vol#: 199

C 5276 Dorothy W. Golson Vol#: 199

C 5277 Carol A. Ruhall Vol#: 199

C 5278 Kathy Wells Vol#: 199

C 5279 Clara Jane Jones Vol#: 199

C 5280 Carolyn C. Bowers Vol#: 199

C 5281 Christie Onwujuba-Dike Vol#: 199

C 5282 Waldene Walpole Vol#: 199

C 5283 Jean S. Williams Vol#: 199

C 5284 Lou Medlock Vol#: 199

C 5285 Rosey C. Farris Vol#: 199

C 5286 Shirley Jacocks Vol#: 199

C 5287 Fannie Reddix Vol#: 199

C 5288 Pat Wilkerson Vol#: 199

C 5289 Velda McCormick Vol#: 199

C 5290 Willie M. Kinbrough Vol#: 199

C 5291 Kizziah Milo Vol#: 199

C 5292 Ingrid C. Milo Vol#: 199

C 5293 Pat Davis Vol#: 199

C 5294 Seola Callahan Vol#: 199

C 5295 Jane Ellett Vol#: 199

C 5296 Clifton C. Conrad, Sr. Vol#: 199

C 5297 Lorraine Sparks Vol#: 199

C 5298 June Sumrall Vol#: 199

C 5299 Gwen Streams Vol#: 199

C 5300 Norma Winegeart Vol#: 199

C 5301 Karen Gray Vol#: 199

C 5302 Barbara L. Murray Vol#: 199

C 5303 Monquente Smilh Vol#: 199

C 5304 Jo Traweek Vol#: 199

C 5305 Patty Lindsey Vol#: 199

C 5306 Jeanette McCalman Vol#: 199

C 5307 Pat Cobb Vol#: 199

C 5308 La Janice Londro Vol#: 199

C 5309 Doris K. Sims Vol#: 199

C 5310 Mary P. Core Vol#: 199

C 5311 Betty Turner Vol#: 199

C 5312 Sandra Edwards Vol#: 199

C 5313 Tasha Zaharako Vol#: 199

C 5314 Beverly A. Larson Vol#: 199

C 5315 Rochelle B. Davis Vol#: 199

C 5316 Becky A. Johnson Vol#: 199

C 5317 R. Norse Vol#: 199

C 5318 Henry, Kelley & Kale Allan Vol#: 199

C 5319 D. A. Martin Vol#: 199

C 5320 Becky Anderson Vol#: 199

C 5321 Robbie Ellis Vol#: 199

C 5322 Peggy & Richard Shuey Vol#: 199

C 5323 Juline Rumsey Vol#: 199

C 5324 Glenda Fleming Vol#: 199

C 5325 Clint Tearman Vol#: 199

C 5326 Janet Kubler Vol#: 199

C 5327 Heather A. Phillips Vol#: 199

C 5328 P. Cohen Vol#: 199

C 5329 Grace E. Naccarato Vol#: 199

C 5330 Eric Holle Vol#: 200

C 5331 Rev. Tom Moran Vol#: 200

C 5332 Gloria Lomax Vol#: 200

C 5333 Marsha McGwire Vol#: 200

C 5334 Todd Pruitt Vol#: 200

C 5335 Tanya C. Kenney Vol#: 200

C 5336 Elisabeth B. Seidl Vol#: 200

C 5337 Joy Sherry Vol#: 200

C 5338 Doris D. Grano Vol#: 200

C 5339 Marion Yoshino Vol#: 200

C 5340 Dalice Snider Vol#: 200

C 5341 James Jennrich Vol#: 200

C 5342 Joan Doyle Vol#: 200

C 5343 Laurie Richardson Vol#: 200

C 5344 Kevin Parkhurst Vol#: 200

C 5345 Grace D. Thomas Vol#: 200

C 5346 Judy Hendrickson Vol#: 200

C 5347 Bernbeck Reichard Vol#: 200

00P-1431 ANDA for elixir containing 10mg hydrocodone bitartrate/650mg

CR 1 HFA-305 Vol#: 1