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 May 4, 2000

Table of Contents

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

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

 
96P-0155 ANDA for Effervescent Lactulose Crystals *
97N-0314 Prescription Drug Products; Levothyroxine Sodium *
98P-0203 Eliminate Forced Molting of Laying Birds *
99D-5347 Transmission of Zoonoses By Blood and Blood Products *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00N-0356 Parasitic Infections In US as Result of Raw Fish Consumption *
88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

NEC 1 Vol#: 3

90N-0056 Parenteral Drug Prod. Containing Aluminum as an Ingredient

N 1 Vol#: 1

SS 1 Supporting statement Vol#: 1

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

NEC 2 Vol#: 3

96P-0155 ANDA for Effervescent Lactulose Crystals

M 1 HFD-615 to Bennett and Co. Vol#: 1

97N-0314 Prescription Drug Products; Levothyroxine Sodium

PAV 1 HFC-1 to Knoll Pharmaceutical Co. Vol#: 1

98F-0430 Sodium acrylate/styrene sulfonate copolymer

NWL 1 Vol#: 1

98P-0203 Eliminate Forced Molting of Laying Birds

C 1948 Cindy M. McDaniel Vol#: 46

C 1949 Patricia J. Barnhart Vol#: 46

C 1950 Sandra Fortune Vol#: 46

99D-5347 Transmission of Zoonoses By Blood and Blood Products

C 30 American Red Cross Vol#: 8

99H-2351 Civil Money Penalty;Hickman Coleman,dba Irondale Food Mart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2457 Civil Money Penalty;Zamiri's Arco,dba Arco AM/PM

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2589 Civil Money Penalty;MFA Petroleum Company.dba Marston Fuel

LET 5 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2666 Civil Money Penalty;Dennis Yourczek,dba Newsette

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2708 Civil Money Penalty;Fuhr Enterprises Inc dba Sunray Amoco

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-3014 Civil Money Penalty;Roswil Inc,dba Ramey's Supermarket

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-3061 Civil Money Penalty;Eads News Inc,dba Eads News & Smoke Shop

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4012 Civil Money Penalty;Ingrams Market,dba Ingrams Market

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4192 Civil Money Penalty;Muzammil Columbia Heights Corp,dba Colum

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4736 Civil Money Penalty;Caton Service Inc,dba Caton Texaco

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4748 Civil Money Penalty;Linson 2 Inc,dba 7-Eleven Store #26753

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4834 Civil Money Penalty;High's of Baltimore Inc,High's of Baltim

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4882 Civil Money Penalty;Bayview Pharmacy Inc,dba Bayview Pharmac

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4889 Civil Money Penalty;High's of Baltimore Incorporated,dba Hig

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4890 Civil Money Penalty;High's of Baltimore Inc,dba High's #46

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4891 Civil Money Penalty;High's of Baltimore Inc,dba High's #95

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4899 Civil Money Penalty;Mt Carmel Medical Inc,dba Mt Carmel Phar

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4922 Civil Money Penalty;High's of Baltimore Incorporated,dba Hig

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4923

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4924 Civil Money Penalty;J & J Park Inc,dba J & J Discount Liquor

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4988 Civil Money Penalty;Yoon Lee;dba Midtown Grocery & Meat

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4990 Civil Money Penalty;Orton Motor, Inc;dba Orton's Wadena Amoc

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4991 Civil Money Penalty;David L. Palensky;dba 7-Eleven #11707

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4995 Civil Money Penalty;Snow Hill Star, Inc;dba Your Stop

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4996 Civil Money Penalty;So-Lo Foods, Inc;dba Valu Foods Supermar

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5003 Civil Money Penalty;Suk In Chung & Haeng Ja Chung,dba Vermon

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5108 Civil Money Penalty;Rich's Standard Inc,dba Rich's Amoco

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5207 Civil Money Penalty;Side Bar & Cafe, Inc;dba Side Bar & Gril

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5259 Civil Money Penalty;Anthony Koehler and Debbie Koehler;dba

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5282 Civil Money Penalty;Excel Marketing,Inc;dba Pennsylvania Ave

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5284 Civil Money Penalty;Janak Enterprises,Inc;dba Mountair Liquo

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5287 Civil Money Penalty;Marvin E. March;dba Foothills Liquors

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5296 Civil Money Penalty;William B. Michel,Jr;dba Ken Caryl Liquo

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5342 Civil Money Penalty;Carl E. Larson Jr,dba Sunshine Corners

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5343 Civil Money Penalty;Lexington Business Ventures Inc,dba Lexi

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5385 Civil Money Penalty;Vern Stover;dba Fast Stop #2

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5387 Civil Money Penalty;Farris Sukkar;dba Farmer's Market

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5406 Civil Money Penalty;James W. Suh;dba Sun Grocery

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5460 Civil Money Penalty;Beaver Park Investments, Inc;dba Kwik St

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5468 Civil Money Penalty;Donovan Woodburn,dba Hop & Sack #18

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5573 Civil Money Penalty;Belmar Avenues, Inc;dba Columbine Wines

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5580 Civil Money Penalty;Donovan Woodburn, Jr;dba Hop & Sack #22

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5582 Civil Money Penalty;Deli-Mart, Inc;dba Fourth Street Market

LET 3 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 10300 Elise Dean Vol#: 356

C 10301 Dr. & Mrs Allan Wasserman Vol#: 356

C 10302 Lois Holmes & John Smith Vol#: 356

C 10303 Kathy J. Trani Vol#: 356

C 10304 Mary A. Mandy Vol#: 356

C 10305 Kathy Albert Vol#: 356

C 10306 Barbara Kann Vol#: 356

C 10307 Darrell Wells Vol#: 356

C 10308 Rona Eisenberger Vol#: 356

C 10309 John Yu Vol#: 356

C 10310 Ken Kurtz & Leann Tourtillott Vol#: 356

C 10311 Jalisa White Vol#: 356

C 10312 Kyle Scroggins Vol#: 356

C 10313 Darion Diasgranads Vol#: 356

C 10314 Joseph Duckett Vol#: 356

C 10315 Florence Crumrine Vol#: 356

C 10316 Ross Pollard Vol#: 356

C 10317 Kimberly Olds Craig Vol#: 356

C 10318 Kim Pace Vol#: 356

C 10319 Jo W. Theye Vol#: 356

C 10320 Ben T. McDonald Coltret Vol#: 356

C 10321 Mary Lord Vol#: 356

C 10322 Gayle Chudd Vol#: 356

C 10323 Andre Kasche Vol#: 356

C 10324 Tori Karpenkco Vol#: 356

C 10325 Maija Kristen Sulend Vol#: 356

C 10326 Brenda L. Haak Vol#: 356

C 10327 Mary Ellsworth Vol#: 357

C 10328 Nancy L. Anderson Vol#: 357

C 10329 Meghan K. Morier Vol#: 357

C 10330 Mike Duncan Vol#: 357

C 10331 Pat Hunsicker Vol#: 357

C 10332 Grace Carbone Vol#: 357

C 10333 Alexandra Stockwell Vol#: 357

C 10334 Martha Plumlee Vol#: 357

C 10335 Shein Collom Vol#: 357

C 10336 Judy Meyer Vol#: 357

C 10337 Melody E. Kroth Vol#: 357

C 10338 Barbara Nutter Vol#: 357

C 10339 Linda J. Gibson Vol#: 357

C 10340 no signature Vol#: 357

C 10341 Jerry R. Bowen Vol#: 357

C 10342 Herschel E. Quarles, Jr. Vol#: 357

C 10343 Celia Ann De Frank Vol#: 357

C 10344 Carol Motosicky Vol#: 357

C 10345 Judith D. Mentzer Vol#: 357

C 10346 Aglaia Rouvalis Vol#: 357

C 10347 Marci Collier Vol#: 357

C 10348 Tion C. McGhee Vol#: 357

C 10349 Stewart & Nancy Steele Vol#: 357

C 10350 Janice L. Cowley Vol#: 357

C 10351 Doris Noe Vol#: 357

C 10352 Catherine Louise McMurray Vol#: 357

C 10353 Bryant Tiffy Vol#: 357

C 10354 Liz Boyles Vol#: 357

C 10355 Joanne Egerton Vol#: 357

C 10356 W. Barbara Toth Vol#: 357

C 10357 Lorraine Hughes Vol#: 357

C 10358 Curtis Martinson Vol#: 357

C 10359 Barbara Bankeroff Vol#: 357

C 10360 James Johnson Vol#: 357

C 10361 Ann Lemieux Vol#: 357

C 10362 Gustava A. Drumm Vol#: 357

C 10363 Julie M. Avery Vol#: 357

C 10364 Thea Jennifer & Nelson Olsen Vol#: 357

C 10365 Betty P. Palmer Vol#: 357

C 10366 Marsha Sutton Vol#: 357

C 10367 Neil & Katie Opitz Vol#: 357

C 10368 Justin Boeve Vol#: 357

C 10369 Alleyne Benson Vol#: 357

C 10370 Amy Black Vol#: 357

C 10371 Karen S. Kotash Vol#: 357

C 10372 Virginia A. Robbins Vol#: 357

C 10373 Kathy O'Brien Vol#: 357

C 10374 Rodger Bufford Vol#: 357

C 10375 Dana Grier Vol#: 357

C 10376 Jim Potter Vol#: 357

C 10377 Jennifer Grande Vol#: 357

C 10378 Virginia DeQuick Vol#: 357

C 10379 Ms. Jessie Carpenter Vol#: 357

C 10380 Debbie Willing Vol#: 357

C 10381 Mary M. Plude Vol#: 357

C 10382 Ms. Starkey Vol#: 357

C 10383 Nan Hawkin Vol#: 357

C 10384 Maren Smith Phillips Vol#: 357

C 10385 Daniel Martens Vol#: 357

C 10386 Amy A. Hansen Vol#: 357

C 10387 Joanne Rogers Vol#: 357

C 10388 Leif E. Winter Vol#: 357

C 10389 Annette Barbosa Vol#: 357

C 10390 Dennis Slotnick Vol#: 357

C 10391 Frieda Krupp Vol#: 357

C 10392 Renay A. Shaffer Vol#: 357

C 10393 Linda L. Peterson Vol#: 357

C 10394 Carrie Zizza Vol#: 357

C 10395 Tiffiny Anders Vol#: 357

C 10396 Amy Beth Kressel Vol#: 357

C 10397 Mrs. Robert L. Peters Vol#: 357

C 10398 Roman & Shelley Garcia Vol#: 357

C 10399 Deanna Sergi Rovse Vol#: 357

C 10400 Janice Riley Vol#: 357

C 10401 Amy Jo Vickery Vol#: 357

C 10402 Cheryl Boerger Vol#: 357

C 10403 Teresa Moorhead Vol#: 357

C 10404 Julia L. Wieck Vol#: 357

C 10405 Patricia Anne Wieck Vol#: 357

C 10406 Janet R. Baltes Vol#: 357

C 10407 Norma Horton Vol#: 357

C 10408 Jesse Rust Vol#: 357

C 10409 Juliet Traka Vol#: 357

C 10410 Rebecca S. Fortig Vol#: 357

C 10411 Kerry Brock Vol#: 357

C 10412 Dr. Susan Buhr Vol#: 357

C 10413 Susan Ripple Vol#: 357

C 10414 Cheryl E. Hartman Vol#: 357

C 10415 Jay Curtis Rockwell Vol#: 357

C 10416 Philip Holt Vol#: 357

C 10417 Marjorie Gordon Vol#: 357

C 10418 Sue Lopez Vol#: 357

C 10419 Arthur Rinehart Vol#: 357

C 10420 Susan Gordon Vol#: 357

C 10421 Mary A. Theodore Vol#: 357

C 10422 Rob & Kate Sorensen Vol#: 357

C 10423 Margarete Weber Vol#: 357

C 10424 Nancy J. Goebbert Vol#: 357

C 10425 Bob & Carol Andrews Vol#: 357

C 10426 Vivian Gutierrez Vol#: 357

C 10427 John V. Roth Vol#: 357

C 10428 Anne Cipkowski Vol#: 357

C 10429 Richard Schwab Vol#: 357

C 10430 Mr & Mrs L. Clinton Reese Vol#: 357

C 10431 Jeff Campbell Vol#: 357

C 10432 Jeff & Holly Murden & Penelope Welz Vol#: 357

C 10433 Dorothy Wallander Vol#: 357

C 10434 Hershel C. Johnson Vol#: 357

C 10435 Ruth L. Sarrett Vol#: 357

C 10436 Linda Fossa Vol#: 358

C 10437 Ishawrence Terrace Vol#: 358

C 10438 Glenda Vailey-Merstton Vol#: 358

C 10439 Robert Thompson Vol#: 358

C 10440 Martha Collier Vol#: 358

C 10441 Sue A. Rechmond Vol#: 358

C 10442 Kimberly Mulvaney Vol#: 358

C 10443 Dorothy Block Vol#: 358

C 10444 Linda C. Chung Vol#: 358

C 10445 Michele & Douglas Kamprath Vol#: 358

C 10446 Thomas K. Orr Vol#: 358

C 10447 Tracy Bechard Vol#: 358

C 10448 Hindy & Kevy Goldis Vol#: 358

C 10449 Sherry Bowlin Vol#: 358

C 10450 Sally Graves Jennings Vol#: 358

C 10451 Sandra Dowling Vol#: 358

C 10452 Kathy Pappalardo Vol#: 358

C 10453 Julie West Vol#: 358

C 10454 Diana Fogel Vol#: 358

C 10455 Eva K. Schulze Vol#: 358

C 10456 Ortwin Klose Vol#: 358

C 10457 Richard R. Blair Vol#: 358

C 10458 Nancy A. Notor Vol#: 358

C 10459 Peggy Boismier Vol#: 358

C 10460 Peggy Boismier Vol#: 358

C 10461 Donna M. VanSickell Vol#: 358

C 10462 Mr & Mrs Michael McGraw Vol#: 358

C 10463 David & Joan Sexton Vol#: 358

C 10464 Sandra Bales Williams Vol#: 358

C 10465 J. Fields Vol#: 358

C 10466 Dieter Siegmund Vol#: 358

C 10467 Shelley Tanner Vol#: 358

C 10468 Kathleen DeNucci Vol#: 358

C 10469 Jenny Wyatt Vol#: 358

C 10470 Timothy R. Williams, Jr. Vol#: 358

C 10471 Mark Shaffer Vol#: 358

C 10472 Friederike DeWolf Vol#: 358

C 10473 Cindy Kisic Vol#: 358

C 10474 P. & C. Kempner Vol#: 358

C 10475 Marion Schoolcraft Vol#: 358

C 10476 Thomas B. Jackson Vol#: 358

C 10477 Lois M. Rosenberg Vol#: 358

C 10478 Berna Welling Vol#: 358

C 10479 Gail Wenger Vol#: 358

C 10480 Sandy McPeake Vol#: 358

C 10481 Mary Inman Vol#: 358

C 10482 Gail Koepf Vol#: 358

C 10483 Carol Thompson Vol#: 358

C 10484 Lucille F. Hoge Vol#: 358

C 10485 Jennifer Wilson Vol#: 358

C 10486 David Schleiches Vol#: 358

C 10487 Nancy Scorcia Vol#: 358

C 10488 Chris Moberg Vol#: 358

C 10489 Patricia Schroer Vol#: 358

C 10490 Beatrice C. Carter Vol#: 358

C 10491 Thomas C. Reeser Vol#: 358

C 10492 Mark & Gillian Grumbo Vol#: 358

C 10493 Mr & Mrs Gary Al. Liggett Vol#: 358

C 10494 Lori Memmen Vol#: 358

C 10495 Sheila Smeltzer Vol#: 358

C 10496 Seth Elliott Vol#: 358

C 10497 Sarah Wilde Vol#: 358

C 10498 Lauranita F. Young Vol#: 358

C 10499 Eric Stafne & Richelle Sink Vol#: 358

C 10500 Vickie Jo Julian Vol#: 358

C 10501 Gail Atkins Vol#: 358

C 10502 Mark A. Gargano Vol#: 358

C 10503 Ellen E. Link Vol#: 358

C 10504 Shirley Jaynes Vol#: 358

C 10505 Carol A. Hale Vol#: 358

C 10506 Candy S. Proctor Vol#: 358

C 10507 Lezli A. Polm Vol#: 358

C 10508 Marie F. Reyburn Vol#: 358

C 10509 Mary Ellen Pettit Vol#: 358

C 10510 Nancy C. Cutcliffe Vol#: 358

C 10511 Nikia N. Morene Vol#: 358

C 10512 W. Becker Vol#: 358

C 10513 Karan Haynes Vol#: 358

C 10514 Lucile Belford Vol#: 358

C 10515 Janet Sudbrink Vol#: 358

C 10516 Jeanette Herring Vol#: 358

C 10517 Carol Burton Vol#: 358

C 10518 Hermann & Uta Zickfeld Vol#: 358

C 10519 Elizabeth A. Keaemer Vol#: 358

C 10520 Anne McDowell Vol#: 358

C 10521 Deanna Birkett Vol#: 358

C 10522 Julie Clark Vol#: 358

C 10523 Elaine M. Niemann Vol#: 358

C 10524 Gayle King Vol#: 358

C 10525 Bruce & Robin Tabano Vol#: 358

C 10526 Nancy Harroth Vol#: 358

C 10527 Mr & Mrs Stanley Kaminski Vol#: 358

C 10528 Michelangelo Salmoiraghi Vol#: 358

C 10529 Daniel L. Wing Vol#: 358

C 10530 Martha S. Gibson Vol#: 358

C 10531 B. Vanderlice Vol#: 358

C 10532 Beth McGuinn Vol#: 358

C 10533 Cheryl Sweeney Vol#: 358

C 10534 Elaine Kraus-Kissam Vol#: 358

C 10535 Kimberleai Thorpe Vol#: 358

C 10536 Edward F. De Rosa Vol#: 358

C 10537 Carlene F. Anderson Vol#: 358

C 10538 Hans Schweiger Vol#: 358

C 10539 S. A. St. Clair Vol#: 358

C 10540 Carmine Buonauito Vol#: 358

C 10541 Joy & David Shirley Vol#: 358

C 10542 Christine Zachai Vol#: 358

C 10543 M & M Coste Vol#: 358

C 10544 Betty King Vol#: 358

C 10545 Tina Tyler Vol#: 358

C 10546 Celia Harlow Vol#: 358

C 10547 Frank G. Schmunk Vol#: 358

C 10548 Kirk Anderson Vol#: 358

C 10549 Winifred P. Wilhelm Vol#: 358

C 10550 LaRee Maucher Vol#: 358

C 10551 Jerry & Hannah Nosh Vol#: 358

C 10552 Allen J. Thiel, Jr. Vol#: 358

C 10553 Dr. Bob Vargo Vol#: 358

C 10554 Jamie Langeler Vol#: 358

C 10555 Allison L. Peak Vol#: 358

C 10556 Glen Shipley Vol#: 358

C 10557 Barbara G. Burgess Vol#: 358

C 10558 Martha Tanjuish Vol#: 358

C 10559 Mary Specht Vol#: 358

C 10560 Keith W. MacKenzie Vol#: 358

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2452 Norm Fluegel Vol#: 185

C 2453 Ms. Linda Hacker Vol#: 185

00N-0356 Parasitic Infections In US as Result of Raw Fish Consumption

C 1 National Food Processors Assn Vol#: 1