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Dockets Management
Dockets Entered On February 24, 2006
Table of Contents
Docket # Title
1980N-0476 Antifungal Drug Products for OTC Human Use
1998P-0724 Prohibition of Cochineal Extract and Carmine Color Additives
1999P-5106 Identify Sources of Natural Flavorings
2000N-1269 Labeling for human prescription drug/Biologic Products
2004E-0039 Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
2005E-0235 Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
2005N-0506 Medical Devices; Cardiovascular Devices; Classification of Implantable Intra-Aneurysm Pressure Measurement System
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006P-0087 To declare that the drug product, Propoxyphene Napsylate, 50 mg and Acetaminophen, 300 mg tablets are suitable for consideration in an abbreviated new drug application (ANDA).
1980N-0476 Antifungal Drug Products for OTC Human Use
ACK 3 HFA-305 to Martha D. Smith Vol #: 21
1998P-0724 Prohibition of Cochineal Extract and Carmine Color Additives
C 6 M. Sook Vol #: 1
C 7 Form Letters Vol #: 4
1999P-5106 Identify Sources of Natural Flavorings
C 71 K. Bothe Vol #: 3
2000N-1269 Labeling for human prescription drug/Biologic Products
C 69 Oklahoma Osteopathic Association Vol #: 5
C 70 Commonwealth of Virginia House of Delegates Vol #: 5
C 71 Senate of Virginia Vol #: 5
C 72 Alliance for Health, Education and Development (AHEAD) Vol #: 5
C 73 Florida Medical Association et al. Vol #: 5
C 74 Commonwealth of Virginia Vol #: 5
C 75 State of Louisiana Vol #: 5
LET 10 HF-40 to Oklahoma Osteopathic Association Vol #: 5
LET 11 HF-40 to Commonwealth of Virginia House of Delegates Vol #: 5
LET 12 HF-40 to Senate of Virginia Vol #: 5
LET 13 HF-40 to Alliance for Health, Education and Development (AHEAD) Vol #: 5
LET 14 HF-40 to Florida Academy of Family Physicians Vol #: 5
LET 15 HF-40 to Commonwealth of Virginia Vol #: 5
LET 16 HF-40 to State of Louisiana Vol #: 5
2004E-0039 Patent Extension for CRESTOR (rosuvastatin), U.S. Patent No. RE37,314
LET 3 HFD-5 to the U.S. Patent and Tradmark Office Vol #: 1
2005E-0235 Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
LET 4 HFD-5 to U.S. Patent and Trademark Office Vol #: 1
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
C 8 Bristol-Myers Squibb Company (BMS) Vol #: 4
C 9 Form Letters Vol #: 13
2005N-0506 Medical Devices; Cardiovascular Devices; Classification of Implantable Intra-Aneurysm Pressure Measurement System
BKG 1 Petition from CardioMEMS, Inc. Vol #: 1
NFR 1 FDA Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EC 5213 Mrs. Barbara Curtis Vol #: 20
EC 5214 Mrs. Susan Lopez Vol #: 20
EC 5215 Ms. Linda Jones Vol #: 20
EC 5216 Global Family Education Center, Inc. Vol #: 20
EC 5217 Mr. James Lopez Vol #: 20
EC 5218 Dr. Robyn Graber Vol #: 20
EC 5219 Ms. deborah stadlin Vol #: 20
EC 5220 Mrs. elizabeth hoffman Vol #: 20
EC 5221 Center for Natural Health Vol #: 20
EC 5222 Ms. Anne Kirvan Vol #: 20
EC 5223 Ms. Connie Musante Vol #: 20
EC 5224 Ms. Stephanie Rushton Vol #: 20
EC 5225 Mrs. Kimberly Thomas Vol #: 20
EC 5226 Mrs. Staci Kalvaitis Vol #: 20
EC 5227 Mrs. Shirley Isenberg Vol #: 20
EC 5228 Ms. Karen Kinney Vol #: 20
EC 5229 Mrs. Susan Berenguer Vol #: 20
EC 5230 Ms. Susan Berndt Vol #: 20
EC 5231 Ms. Janet Delgado Vol #: 20
EC 5232 Arbonne Vol #: 20
EC 5233 Ms. Anne LaFriniere Vol #: 20
EC 5234 Educator Vol #: 20
EC 5235 Mrs. Donna Thorwaldson Vol #: 20
EC 5236 None Vol #: 20
EC 5237 Ms. Lynn Deen Vol #: 20
EC 5238 Mrs. Sheryl Hewett Vol #: 20
EC 5239 Ms. Marie Oswald Vol #: 20
EC 5240 Mrs. Regan Halkyard Vol #: 20
EC 5241 Mrs. Patricia Schneider Vol #: 20
EC 5242 Mrs. KATHY CLEM Vol #: 20
EC 5243 Ms. diane Grover Vol #: 20
EC 5244 Ms. Elaine Van Gunst Vol #: 20
EC 5245 Mrs. SANDRA SANTIAGO Vol #: 20
EC 5246 Mrs. Lisa Boynick Vol #: 20
EC 5247 Ms. Debra Germain Vol #: 20
EC 5248 Mrs. Penny Long Vol #: 20
EC 5249 Ms. Janet Yunker Vol #: 20
EC 5250 Ms. Elizabeth Mainella Vol #: 20
EC 5251 Ms. Mary Sadler Vol #: 20
EC 5252 Mrs. Nona Ferguson Vol #: 20
EC 5253 Ms. Marilyn Wood Vol #: 20
EC 5254 Mrs. Theresa Polley Vol #: 20
EC 5255 Consumer Vol #: 20
EC 5256 Massachusetts General Hospital Vol #: 20
EC 5257 Ms. Patricia Eubanks Vol #: 20
EC 5258 Ms. Rebecca Downs Vol #: 20
EC 5259 Ms. Deborah Blake Vol #: 20
EC 5260 Ms. Lisa Hoffman Vol #: 20
EC 5261 Ms. Carol Lett Vol #: 20
EC 5262 Mrs. Barbara Davids Vol #: 20
EC 5263 N/A Vol #: 20
EC 5264 Mrs. Nancy Renwick Vol #: 20
EC 5265 Ms. Mary Reed Vol #: 20
EC 5266 Mrs. patricia enloe Vol #: 20
EC 5267 Ms. arleen kern Vol #: 20
EC 5268 Mrs. Diane Wilson Vol #: 20
EC 5269 Ms. Susan Carey Vol #: 20
EC 5270 Ms. Pamela Schmidt Vol #: 20
EC 5271 Dr. fiona lovely Vol #: 20
EC 5272 Mrs. Cheryl Mackie Vol #: 20
EC 5273 Mrs. Valerie White Vol #: 20
EC 5274 Mrs. Bonnie Bemis Vol #: 20
EC 5275 Ms. Karen Ross Vol #: 20
EC 5276 Mrs. Stephanie Zoley Vol #: 20
EC 5277 Ms. Caroline Brown Vol #: 20
EC 5278 Mrs. Denise Gluhan Vol #: 20
EC 5279 Ms. Audra Shope Vol #: 20
EC 5280
Attachment
Ms. Terri Weisenbach Vol #: 20
EC 5281 Mrs. Phyllis McGinnis Vol #: 20
EC 5282 Mrs. Monica Jordan Vol #: 20
EC 5283 Community Drug Compounding Center Vol #: 20
EC 5284 Mrs. Debra Velez Vol #: 20
EC 5285 Mrs. Maria Holtkamp Vol #: 20
EC 5286 Mrs. Ann Slattery Vol #: 20
EC 5287 Miss. alyce hinkle Vol #: 20
EC 5288 Mrs. Phyllis McGinnis Vol #: 20
EC 5289 Ms. Glennis Peterson Vol #: 20
EC 5290 Private practice Vol #: 20
EC 5291 Ms. Anna Cassilly Vol #: 20
EC 5292 Mrs. Beverly Parton Vol #: 20
EC 5293 Dr. M Keoppen Vol #: 20
EC 5294 Mrs. Kayella Bickes Vol #: 20
EC 5295 Mrs. Mary Kate MacKenzie Vol #: 20
EC 5296 Mrs. Katherine Doyle Vol #: 20
EC 5297 Ms. Paula Scarpellino Vol #: 20
EC 5298 Miss. Eden Venti Vol #: 20
EC 5299 Ms. christine orrall Vol #: 20
EC 5300 Ms. Lisa Danford Vol #: 20
EC 5301 NONE Vol #: 20
EC 5302 Ms. Melissa Brinkerhoff Vol #: 20
EC 5303 Dr. Gary Keel Vol #: 20
EC 5304 Mrs. Jennifer Fiebelkorn Vol #: 20
EC 5305 Ms. Sharon Bertsch Vol #: 20
EC 5306 Ms. Carolyn Bowen Vol #: 20
EC 5307 Mrs. Nicole Rose Vol #: 20
EC 5308 Mrs. debra flaherty Vol #: 20
EC 5309 Ms. Kathy Finn Vol #: 20
EC 5310 Mrs. JoAnne Smith Vol #: 20
EC 5311 Dr. Gayle DeBay Vol #: 20
EC 5312 Miss. Elizabeth Jinks Vol #: 20
EC 5313 Mrs. Jo Yeargan Vol #: 20
EC 5314 Mrs. louise waddick Vol #: 20
EC 5315 Mrs. Alice pollard Vol #: 20
EC 5316 Ms. Femida Dhanani Vol #: 20
EC 5317 Mrs. Linda Dowd Vol #: 20
EC 5318 Miss. Kathleen Fodrek Vol #: 20
EC 5319 Ms. Tamara Loring Vol #: 20
EC 5320 Mr. Mike Riepl, R.Ph. Vol #: 20
EC 5321 Mrs. Dorothy Troyer Vol #: 20
EC 5322 Mrs. Jodie Shull Vol #: 20
EC 5323 Ms. Patricia MacMillan Vol #: 20
EC 5324 Mrs. Patricia Vaughan Vol #: 20
EC 5325 Mrs. Lisa DeBuse Vol #: 20
EC 5326 Ms. Martha Morrill Vol #: 20
EC 5327 Ms. Julie Piankoff Vol #: 20
EC 5328 Mrs. Dodie O'Donnell Vol #: 20
EC 5329 Mrs. Karen Lombard Vol #: 20
EC 5330 Moondance Acupuncture Vol #: 20
EC 5331 Miss. Katherine Shelton Vol #: 20
EC 5332 Certified Professional Midwife, MANA Vol #: 20
EC 5333 Mrs. Dawn Phillips Vol #: 20
EC 5334 Ms. Maryfrances Phillippi Vol #: 20
EC 5335 Ms. Wendy Langenderfer Vol #: 20
EC 5336 Ms. Kathy Fieberling Vol #: 20
EC 5337 Mrs. Langley Ruede Vol #: 20
EC 5338 Ms. Angela Benner Vol #: 20
EC 5339 Mrs. Wendy DaSilva Vol #: 20
EC 5340 Mrs. Carol Gessner Vol #: 20
EC 5341 Mrs. Marian Szymanski Vol #: 20
EC 5342 Ms. Sheila Larkin Vol #: 20
EC 5343 Mrs. Jean Ballew Vol #: 20
EC 5344 Ms. Sharon Krantz Vol #: 20
EC 5345 Ms. melanie parsons Vol #: 20
EC 5346 Ms. Susan Reinhardt Vol #: 20
EC 5347 Mandalyn Academy, Skin Vol #: 20
EC 5348 Ms. M. Diane Born Vol #: 20
EC 5349 Ms. Julie Johnson Vol #: 20
EC 5350 Ms. Alison Roth Vol #: 20
EC 5351 Ms. Jane P. Murphy Vol #: 20
EC 5352 Ms. Karin Pine Vol #: 20
EC 5353 Ms. Lori SchraderBachar Vol #: 20
EC 5354 Ms. Yolanda Rodriguez Vol #: 20
EC 5355 Ms. Eileen Campbell Vol #: 20
EC 5356 Ms. Beverly Gill Vol #: 20
EC 5357 Ms. JSue Robertson Vol #: 20
EC 5358 Southern Nevada Neonatal Services Vol #: 20
EC 5359 Mrs. Jamie Hetherington Vol #: 20
EC 5360 Mrs. Doreen Christensen Vol #: 20
EC 5361 Mrs. Josie Showalter Vol #: 20
EC 5362 Mrs. Debra Belk Vol #: 20
EC 5363 Mrs. Sandy Throne Vol #: 20
EC 5364 Mrs. Carol Thompson Vol #: 20
EC 5365 Mrs. Nancy Radford Vol #: 20
EC 5366 Mrs. Cindy LeMarr Vol #: 20
EC 5367 Ms. Susan O'Neill, NP Vol #: 20
EC 5368 Mr. Richard Grant Vol #: 20
EC 5369 Dr. Mayo Friedlis MD Vol #: 20
EC 5370 Ms. Melissa Cook Vol #: 20
EC 5371 Mr. John Williams Vol #: 20
EC 5372 Ms. Cynthia Sinclair Vol #: 20
EC 5373 Dr. Jan Maher Vol #: 20
EC 5374 Ms. Melanie Kelman Vol #: 20
EC 5375 Ms. Carolyn McDonald Vol #: 20
EC 5376 Mrs. Susan Villalobos-Boehm Vol #: 20
EC 5377 Ms. Elaine Stattman Vol #: 20
EC 5378 Dr. Alexa Laurie Vol #: 20
EC 5379 Embrace- The Mind, Body Vol #: 20
EC 5380 Mrs. Deborah Limoge Vol #: 20
EC 5381 Mr. Steven Guy Vol #: 20
EC 5382 Ms. Patricia Steele Vol #: 20
EC 5383 Mrs. Sue Ducklow Vol #: 20
EC 5384 Ms. Jeanine Jamieson Vol #: 20
EC 5385 Ms. Ann Masai Jones Vol #: 20
EC 5386 Mrs. Amy Price Vol #: 20
EC 5387 Mrs. Sherry Ollison Vol #: 20
EC 5388 Mrs. Jennifer Ackim Vol #: 20
EC 5389 Mr. Allen Foley Vol #: 20
EC 5390 Mrs. Phillipa Lion Vol #: 20
EC 5391 Mrs. Amanda Mize Vol #: 20
EC 5392 Ms. Bonnie Marshall Vol #: 20
EC 5393 Mrs. Helena Aktar Vol #: 20
EC 5394 Dr. Brian Seifferth Vol #: 20
EC 5395 Mrs. Barbara Perry Vol #: 20
EC 5396 Ms. Mary O'Neal Vol #: 20
EC 5397 Ms. Cindy Abernathy Vol #: 20
EC 5398 Mrs. Julie Meress Vol #: 20
EC 5399 Mrs. Ginny Charles Vol #: 20
EC 5400 New Day Communication, Incorporated Vol #: 20
EC 5401 Mrs. Della Gunning Vol #: 20
EC 5402 Ms. Sherri Q Vol #: 20
EC 5403 Mrs. linda starkey Vol #: 20
EC 5404 Mrs. Lori Mang Vol #: 20
EC 5405 Ms. Darla Wilson Vol #: 20
EC 5406 Mrs. Kerry Stefano Vol #: 20
EC 5407 Mrs. Mindy Albert Vol #: 20
EC 5408 Mrs. Martha Bossick-Campbell Vol #: 20
EC 5409 Mrs. Lucy Heffelfinger Vol #: 20
2006P-0087 To declare that the drug product, Propoxyphene Napsylate, 50 mg and Acetaminophen, 300 mg tablets are suitable for consideration in an abbreviated new drug application (ANDA).
ACK 1 HFA-305 to Lachman Consultant Services, Inc. Vol #: 1
CP 1 Lachman Consultant Services, Inc. Vol #: 1

Page created on March 23, 2006 RSC

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