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

DOCKETS ENTERED on July 28, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]

98D-0481 180-day Generic Drug Exclusivity - Hatch-Waxman Amendmen *
98N-1265 Distribution of Compounded Drug Products *
98P-0145 Requirements for demonstrating In Vivo Bioequivalence *
99N-2079 Assessment of Preclinical Reproductive Toxicity Data *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99V-2536 Laser Light Show *
97N-0435 New animal drug regulation/substantial evidence

NFR 1 HFV-6 Vol#: 1

98D-0017 Validation of Analytical Procedures: Definition & Terminolog

GDL 3 HFV-140 Vol#: 1

NAD 2 HFV-12 Vol#: 1

98D-0481 180-day Generic Drug Exclusivity under Hatch-Waxman Amendmen

C 14 Andrx Corp. Vol#: 1

98N-0222 Dissemination of Information on Unapproved/New Uses

N 2 Vol#: 1

98N-0320 Health Claim or Nutrient Content Claim;Information Collectio

N 3 Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 4385 Mrs Mable Mattox Vol#: 144

C 4386 Valerie Greco Vol#: 144

C 4387 Charlotte DeVeno Vol#: 144

C 4388 Sally L Wallace Vol#: 144

C 4389 Phyllis Dolinger Vol#: 144

C 4390 Marjorie Batz Vol#: 144

C 4391 N Doniger Vol#: 144

C 4392 Catherine J Brown Vol#: 144

C 4393 Janet K Nash Vol#: 144

C 4394 Debra Fecht Vol#: 144

C 4395 Gloria M Horne Vol#: 144

C 4396 Susan Dorto Vol#: 144

C 4397 Susan Durling Vol#: 144

C 4398 Barbara Mallek Vol#: 144

C 4399 Margaret A McKenny Vol#: 144

C 4400 Catherine T Luce Vol#: 144

C 4401 Robert L Way Vol#: 144

C 4402 Nell Firmender Vol#: 144

C 4403 Frances A Way Vol#: 144

C 4404 Sister Maria R Rodriguez Vol#: 144

C 4405 Kathryn M Gabbard Vol#: 144

C 4406 Jim H Stucker Vol#: 144

C 4407 Pam Crowe Vol#: 144

C 4408 Sharon Horn Vol#: 144

C 4409 Dawn Barrett Vol#: 144

C 4410 Monika N Macezinskas Vol#: 144

C 4411 Joan DeRosa Vol#: 144

C 4412 Maxine Marple Vol#: 144

C 4413 Susan May Vol#: 144

C 4414 Mary Ann Franks Vol#: 144

C 4415 Lil Collier Vol#: 144

C 4416 Wandra Frisen Vol#: 144

C 4417 Margaret M Giordano Vol#: 144

C 4418 Martha Bullock Vol#: 144

C 4419 Nancy Gardner Vol#: 144

C 4420 M A McRedmond Vol#: 144

C 4421 Lynn Molenda Vol#: 144

C 4422 Mary B Barbush Vol#: 144

C 4423 Shirley Dewitt Vol#: 144

C 4424 Janice R Veetman Vol#: 144

C 4425 Joanne M Biscone Vol#: 144

C 4426 Barbara L Buzuit Vol#: 144

C 4427 Collien Tait Vol#: 144

C 4428 Marie Cluifevri Vol#: 144

C 4429 Denise DeFeua Vol#: 144

C 4430 Victoria Chillemi Vol#: 144

C 4431 Sharon Mitchell Vol#: 144

C 4432 Gayle Herrman Vol#: 144

C 4433 Joan DeRosa Vol#: 144

C 4434 Jeanne M Biscone Vol#: 144

C 4435 JoAnn Strachan Bruzek Vol#: 144

C 4436 Nancy Ponr Vol#: 144

C 4437 Kathy Chase Vol#: 144

C 4438 Belinda C Martin Vol#: 144

C 4439 Beverly Silverman Vol#: 144

C 4440 Veronica Wardwell Vol#: 144

C 4441 Jewell S Clark Vol#: 144

C 4442 Denise S Pais Vol#: 144

C 4443 Gale Killion Vol#: 144

C 4444 Joanne Rockhalt Vol#: 144

C 4445 Patricia Wohn Vol#: 144

C 4446 Mrs Russell Hedinger Vol#: 144

C 4447 Sandra J Kube Vol#: 144

C 4448 Deborah M Finley Vol#: 144

C 4449 Kathryn Warren-Pandolio Vol#: 144

C 4450 J Lessila Vol#: 144

C 4451 Pat Bergles Vol#: 144

C 4452 Marcia Barritt Vol#: 144

C 4453 Jane Gerken Vol#: 144

C 4454 Paula M Woods Vol#: 144

C 4455 Sandra Harris Vol#: 144

C 4456 Illegible Vol#: 144

C 4457 Mary Garnett-Hayes Vol#: 144

C 4458 Sharon Ricardo Vol#: 144

C 4459 Yvonne M Hansen Vol#: 144

C 4460 Janan Cohen Vol#: 144

C 4461 Dorothy Ballantine Vol#: 144

C 4462 Eleanore Juza Vol#: 144

C 4463 William M Smith Jr Vol#: 144

C 4464 Janelle Miller Vol#: 144

C 4465 Roxanne Paisns Vol#: 144

C 4466 Rita Merk Vol#: 144

C 4467 Illegible Vol#: 144

C 4468 Carolann A Selwood Vol#: 144

C 4469 Joanne Willen PhD Vol#: 144

C 4470 Anna Van Gunten Vol#: 144

C 4471 Lillian A Wiebeld Vol#: 144

C 4472 Anne B Jenkins Vol#: 144

C 4473 Carol de Harak Vol#: 144

C 4474 Joan Rottenberg Vol#: 144

C 4475 Flora Fraternali Vol#: 144

C 4476 Vivian C Scott Vol#: 144

C 4477 Karen Muli Vol#: 144

C 4478 Mary C Dewitt Vol#: 144

C 4479 Darcy F Wallen Vol#: 144

C 4480 Mary Lou Coffvan Vol#: 144

C 4481 Selma Mindes PhD Vol#: 144

C 4482 Sandra Semple-Nelson Vol#: 144

C 4483 Judith Joosten Vol#: 144

C 4484 Dorothy M Smith Vol#: 144

C 4485 Diane Liebst Vol#: 144

C 4486 Linda E Savage PhD Vol#: 144

98P-0145 Requirements for demonstrating In Vivo Bioequivalence

C 14 Andrx Corp. Vol#: 4

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 185 Form Letter Count 640 Vol#: 11

99D-2248 Efficacy of Anthelmintics for Bovines,Ovines and Caprines

GDL 1 Vol#: 1

NAD 1 Vol#: 1

99H-0675 Civil Money Penalties;Hamrick's Inc,d/b/a Carousel Liquor

CS 1 HFA-305 Vol#: 1

MO 1 GCF-1 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99N-2079 Assessment of Preclinical Reproductive Toxicity Data

C 1 Tap Holdings Inc Vol#: 1

LST 1 Agenda of June 24, 1999 meeting Vol#: 1

NM 1 Vol#: 1

TR 1 Transcript of June 24, 1999 meeting Vol#: 2

TS 1 HFD-24 Vol#: 1

TS 2 HFD-530 Vol#: 1

TS 3 HFD-570 Vol#: 1

TS 4 Patrick Wier Vol#: 1

TS 5 R.W.Johnson Pharmaceutical Research Inst Vol#: 1

TS 6 Pharmacia & Upjohn Vol#: 1

TS 7 Ed Fisher Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1234 Monica E. Vol#: 20

C 1235 Saul Robbins Vol#: 20

C 1236 Sandra Smith Vol#: 20

C 1237 Neil Kolwey Vol#: 20

C 1238 Charlette Plinneke Vol#: 20

C 1239 Joyce Zaccaro Vol#: 20

C 1240 Mr. Manfred McArthur Vol#: 20

C 1241 Richard Davis Vol#: 20

C 1242 Sandra & Douglas Lawrence Vol#: 20

C 1243 Roald Cann Vol#: 20

C 1244 Holly Odell Vol#: 20

C 1245 Betsi Lattimer Vol#: 20

C 1246 Phily Simon Vol#: 20

C 1247 Geraldine Johnson Vol#: 20

C 1248 Colleen Kunkel Vol#: 20

C 1249 Wheaton Franciscan Sisters Vol#: 20

C 1250 Michael Kunkel Vol#: 20

C 1251 Sandra F. Walters Vol#: 20

C 1252 John Gear Vol#: 20

C 1253 Walt Socha Vol#: 20

C 1254 Rhoda & Mike Freier Vol#: 20

C 1255 Mary H. Gerwin Vol#: 20

C 1256 George E. Milkowski Vol#: 20

C 1257 Linda Rogers, RN Vol#: 20

C 1258 E. Goffin Vol#: 20

C 1259 Susan L. Halvorsen Vol#: 20

C 1260 Claire A. Nivola Vol#: 20

C 1261 Nancy Johansson Vol#: 20

C 1262 Guy Gray Vol#: 20

C 1263 Joan M. Goodwin Vol#: 20

C 1264 Martha E. Martin Vol#: 20

C 1265 Mrs. Edgar Lehman Vol#: 20

C 1266 Mary J. Honeycutt Vol#: 20

C 1267 Susan Clayton Vol#: 20

C 1268 Adele Martin Vol#: 20

C 1269 Steven Roesch Vol#: 20

C 1270 Joline N. Ozanne Vol#: 20

C 1271 Wanda Cawein Vol#: 20

C 1272 Matthew Papertsian Vol#: 20

C 1273 Paul Baker Vol#: 20

C 1274 Cathryn Baker Vol#: 20

C 1275 Doris E. Bouwensch Vol#: 20

C 1276 James F. Montgomery Vol#: 20

C 1277 Martha Bushnell, Ph.D. Vol#: 20

C 1278 Olivia Mandel Vol#: 20

C 1279 Rendon Holloway Vol#: 20

C 1280 Marie E. Verbout Vol#: 21

C 1281 Shirl Thomas Vol#: 21

C 1282 Stephen & Karen Flint Vol#: 21

C 1283 Michele Cella Vol#: 21

C 1284 Nouror Bashshur Vol#: 21

C 1285 Judy Simon Vol#: 21

C 1286 Mrs. Emily S. McConnell Vol#: 21

C 1287 Eleni Mott Vol#: 21

C 1288 Ardis J. Browne Vol#: 21

C 1289 Alfred Lockwood Vol#: 21

C 1290 Christopher A. Mason Vol#: 21

C 1291 Katharine C. Hunvald Vol#: 21

C 1292 Habib Rathle, M.D., FAAP Vol#: 21

C 1293 Mollie Portner Vol#: 21

C 1294 Robert Littlefield Vol#: 21

C 1295 Mr. & Mrs. Dale Sheldon Vol#: 21

C 1296 Jan Kramer Vol#: 21

C 1297 Carol Hayman Vol#: 21

C 1298 Michael Letendre Vol#: 21

C 1299 Eric Starnes Vol#: 21

C 1300 Patricia A. Longoria Vol#: 21

C 1301 Jeanette Woolsey Vol#: 21

C 1302 Mary B. Dekleva Vol#: 21

C 1303 David R. Sokol Vol#: 21

C 1304 Kelley Smith Vol#: 21

C 1305 Letty Terrens Vol#: 21

C 1306 Mona Cardell Vol#: 21

C 1307 Silvia Fiondo Vol#: 21

C 1308 Carey Vol#: 21

C 1309 Carol Strayer Vol#: 21

C 1310 Daniel Silver, M.D. Vol#: 21

C 1311 Mary B. Vant Hull Vol#: 21

C 1312 Doris S. Johnston Vol#: 21

C 1313 Charlotte Cimino Vol#: 21

C 1314 Susan M. Smith Vol#: 21

C 1315 Joe Barbosa, M.D. Vol#: 21

C 1316 Kay M. Yeuell Vol#: 21

C 1317 Andrew Kolosseus Vol#: 21

C 1318 Edward C. Pope Vol#: 21

C 1319 Susan Bradfield Vol#: 21

C 1320 David M. Matthews Vol#: 21

C 1321 Wina Mortenson Vol#: 21

C 1322 Joseph Mayer Vol#: 21

C 1323 Julie Beer Vol#: 21

C 1324 Elizabeth J. Hohman Vol#: 21

C 1325 Sally Smithern Vol#: 21

C 1326 Frances Lamberts Vol#: 21

C 1327 Carol Legarra Vol#: 21

C 1328 Melinda Roy Vol#: 21

C 1329 Michael N. & Pearl S. Held Vol#: 21

C 1330 Jim Mosser Vol#: 21

C 1331 Kathy VanDame Vol#: 21

C 1332 Sandra Morrison Vol#: 21

C 1333 John Spezia Vol#: 21

C 1334 J. T. Montpas Vol#: 21

C 1335 Darrell G. Wells Vol#: 21

C 1336 Marion & Kenneth Harris Vol#: 21

99V-2536 Laser Light Show

VAR 1 Thunderbolt sound & Lighting, Inc. Vol#: 1