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Dockets Management

Dockets Entered On February 6, 2007
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998E-0849 Patent Extension 4,490,351 VITREON
1999E-5116 Patent Extension: Xoponex, levalbuterol hcl, #5,362,755
2001E-0096 Dantochlor RW/Dantobrom RW, Patent Extension Application
2002E-0100 Patent Application for Dutrasteride
2003E-0243 Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
2003E-0244 Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
2003E-0252 Patent Extension for A180 (danofloxacin mesylate), 4,861,779
2003E-0254 Patent Extension for Inspra (eplerenone), 4,559,332
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
2003N-0573 Draft Animal Cloning Risk Assessment
2004E-0314 Patent Extension for Spiriva HandiHaler (tiotropium bromide inhalation powder), U.S. Patent No. 5,610,163
2004E-0389 Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
2005E-0258 Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
2005N-0105 Proposal to Debar James T. Kimball; Notice of Opportunity for Hearing
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
2006D-0413 Guidance for Industry: Blue Bird Medicated Feed Labels
2007E-0046 Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
2007N-0016 Sentinel Network To Promote Medical Product Safety
2007P-0044 Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 18253 NBTY Inc. Vol #: 168
LET 18254 NBTY Inc. Vol #: 168
LET 18255 New Chapter Inc. Vol #: 168
LET 18256 New Chapter Inc. Vol #: 168
LET 18257 New Chapter Inc. Vol #: 168
LET 18258 New Chapter Inc. Vol #: 168
LET 18259 New Chapter Inc. Vol #: 168
LET 18260 New Chapter Inc. Vol #: 168
LET 18261 New Chapter Inc. Vol #: 168
LET 18262 NBTY Inc. Vol #: 168
LET 18263 NBTY Inc. Vol #: 168
LET 18264 NBTY Inc. Vol #: 168
LET 18265 NBTY Inc. Vol #: 168
LET 18266 NBTY Inc. Vol #: 168
LET 18267 NBTY Inc. Vol #: 168
LET 18268 NBTY Inc. Vol #: 168
LET 18269 NBTY Inc. Vol #: 168
LET 18270 NBTY Inc. Vol #: 168
LET 18271 NBTY Inc. Vol #: 168
LET 18272 NBTY Inc. Vol #: 168
LET 18273 NBTY Inc. Vol #: 168
LET 18274 New Chapter, Inc. Vol #: 168
LET 18275 New Chapter, Inc. Vol #: 168
LET 18276 New Chapter, Inc. Vol #: 168
LET 18277 New Chapter, Inc. Vol #: 168
LET 18278 New Chapter, Inc. Vol #: 168
LET 18279 New Chapter, Inc. Vol #: 168
LET 18280 New Chapter, Inc. Vol #: 168
LET 18281 New Chapter, Inc. Vol #: 168
LET 18282 New Chapter, Inc. Vol #: 168
LET 18283 New Chapter, Inc. Vol #: 168
LET 18284 New Chapter, Inc. Vol #: 168
LET 18285 New Chapter, Inc. Vol #: 168
LET 18286 New Chapter, Inc. Vol #: 168
LET 18287 New Chapter, Inc. Vol #: 168
LET 18288 New Chapter, Inc. Vol #: 168
LET 18289 New Chapter, Inc. Vol #: 168
LET 18290 New Chapter, Inc. Vol #: 168
LET 18291 New Chapter, Inc. Vol #: 168
LET 18292 New Chapter, Inc. Vol #: 168
LET 18293 New Chapter, Inc. Vol #: 168
LET 18294 Dietary Ingredient Solutions, LLC Vol #: 168
LET 18295 Hillestad Pharmaceuticals USA, Inc. Vol #: 168
LET 18296 Perrigo Company of South Carolina Vol #: 168
LET 18297 Perrigo Company of South Carolina Vol #: 168
LET 18298 Perrigo Company of South Carolina Vol #: 168
LET 18299 Perrigo Company of South Carolina Vol #: 168
LET 18300 Perrigo Company of South Carolina Vol #: 168
LET 18301 Perrigo Company of South Carolina Vol #: 168
LET 18302 Perrigo Company of South Carolina Vol #: 168
LET 18303 Perrigo Company of South Carolina Vol #: 168
LET 18304 Perrigo Company of South Carolina Vol #: 168
LET 18305 Perrigo Company of South Carolina Vol #: 168
LET 18306 Perrigo Company of South Carolina Vol #: 168
LET 18307 Perrigo Company of South Carolina Vol #: 168
LET 18308 Perrigo Company of South Carolina Vol #: 168
LET 18309 Perrigo Company of South Carolina Vol #: 168
LET 18310 NBTY Inc. Vol #: 168
LET 18311 NBTY Inc. Vol #: 168
LET 18312 NBTY Inc. Vol #: 168
LET 18313 NBTY Inc. Vol #: 168
LET 18314 NBTY Inc. Vol #: 168
LET 18315 NBTY Inc. Vol #: 168
LET 18316 NBTY Inc. Vol #: 168
LET 18317 NBTY Inc. Vol #: 168
LET 18318 NBTY Inc. Vol #: 168
LET 18319 NBTY Inc. Vol #: 168
LET 18320 NBTY Inc. Vol #: 168
LET 18321 NBTY Inc. Vol #: 168
1998E-0849 Patent Extension 4,490,351 VITREON
CEP 1 U.S. Patent and Trademark Office to Wood, Herron & Evans, LLP Vol #: 1
1999E-5116 Patent Extension: Xoponex, levalbuterol hcl, #5,362,755
CEP 1 U.S. Patent and Trademark Office Vol #: 1
2001E-0096 Dantochlor RW/Dantobrom RW, Patent Extension Application
LET 3 U.S. Patent and Trademark Office to Darby & Darby PC Vol #: 1
2002E-0100 Patent Application for Dutrasteride
LET 6 U.S. Patent and Trademark Office to GlaxoSmithKline Vol #: 1
2003E-0243 Patent Extension for InFuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device, 5,984,967
LET 3 U.S. Patent and Trademark Office to FDA/CDER (HFD-7) Vol #: 1
2003E-0244 Patent InFuse Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, 5,782,919
LET 3 U.S. Patent and Trademark Office to FDA/CDER (HFD-7) Vol #: 1
2003E-0252 Patent Extension for A180 (danofloxacin mesylate), 4,861,779
LET 4 U.S. Patent and Trademark Office to Pfizer Inc. Vol #: 1
2003E-0254 Patent Extension for Inspra (eplerenone), 4,559,332
LET 5 U.S. Patent and Trademark Office to Pharmacia Corporation of Pfizer Inc. Vol #: 1
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
EC 39 None Vol #: 8
2003N-0573 Draft Animal Cloning Risk Assessment
EC 3228 Ms. Amanda Hall Vol #: 17
EC 3229 Ms. Jeanne Charles Vol #: 17
EC 3230 Mr. Byron Rendar Vol #: 17
EC 3231 Dr. Catherine Kettrick Vol #: 17
EC 3232 Mr. P Wiyda Vol #: 17
EC 3233 Mrs. julie pfender Vol #: 17
EC 3234 Mr. Patrick Weber Vol #: 17
EC 3235 Ms. Alison Oscar Vol #: 17
EC 3236 Ms. christine barnett Vol #: 17
EC 3237 Ms. Adrienne Dale Vol #: 17
EC 3238 Ms. Adriana Faria Vol #: 17
EC 3239 Ms. Stefanie Weaver Vol #: 17
EC 3240 Mrs. Amber Johnson Vol #: 17
EC 3241 Miss. Jennifer Baugus Vol #: 17
EC 3242 Ms. Beth McDermott Vol #: 17
EC 3243 Ms. Dorolyn Barnett Vol #: 17
EC 3244 Ms. Gabrielle Suh Vol #: 17
EC 3245 Ms. Beth Duggan Vol #: 17
EC 3246 Ms. Angela Black Vol #: 17
EC 3247 Mr. Joseph Gross Vol #: 17
EC 3248 Mrs. Cheyenne Denny Vol #: 17
EC 3249 Ms. darynne jessler Vol #: 17
EC 3250 none Vol #: 17
EC 3251 Ms. Dawn Robinson Vol #: 17
EC 3252 Ms. Diane Knudson Vol #: 17
EC 3253 Miss. Christine Bittner Vol #: 17
EC 3254 Ms. Beth Heffernan Vol #: 17
EC 3255 Mr. Chris Corley Vol #: 17
EC 3256 Ms. Sheila HUBBARD Vol #: 17
EC 3257 Ms. Edith Simpson Vol #: 17
EC 3258 Ms. CINDY DE LA GARZA Vol #: 17
EC 3259 Ms. CINDY DE LA GARZA Vol #: 17
EC 3260 Ms. CINDY DE LA GARZA Vol #: 17
EC 3261 Ms. debra dillon Vol #: 17
EC 3262 Ms. Dianna Whitley Vol #: 17
EC 3263 Ms. Gretchen Schneider Vol #: 17
EC 3264 Ms. Deniz Bolbol Vol #: 17
EC 3265 American Medical Association Vol #: 17
EC 3266 Mrs. Barbara Kerkhoff Vol #: 17
EC 3267 Ms. gina blum Vol #: 17
EC 3268 Ms. robin thompson Vol #: 17
EC 3269 Mr. adam blumenthal Vol #: 17
EC 3270 Ms. Deborah Meldahl Vol #: 17
EC 3271 Ms. Evelyn Kimber Vol #: 17
EC 3272 Mrs. Cheryl Martin Vol #: 17
EC 3273 Mrs. doreen rudnick Vol #: 17
EC 3274 Ms. D Brown Vol #: 17
EC 3275 Mr. Christophe Ouedec Vol #: 17
EC 3276 Ms. jan Boggesss Vol #: 17
EC 3277 Miss. Jeanette Holmgren Vol #: 17
EC 3278 Ms. Barbara OBrien Vol #: 17
EC 3279 Ms. Elizabeth McKibbin Vol #: 17
EC 3280 Miss. Natalie Van Leekwijck Vol #: 17
EC 3281 Ms. Elsie Zecchino Vol #: 17
EC 3282 Ms. Patricia Browne Vol #: 17
EC 3283 Ms. Janet Pearson Vol #: 17
EC 3284 Mrs. Gretchen Ryan Vol #: 17
EC 3285 Mr. John L. Keiser Vol #: 17
EC 3286 Mrs. Sherry Frey-Brown Vol #: 17
EC 3287 Ms. Heidi Liebwein Vol #: 17
EC 3288 Mrs. Heather Savino Vol #: 17
EC 3289 Mrs. Mary Schilder Vol #: 17
EC 3290 Ms. Joan Bull Vol #: 17
EC 3291 Ms. Janis Galligan Vol #: 17
EC 3292 Mrs. Jamie Pratt Vol #: 17
EC 3293 Ms. elaine mcCall Vol #: 17
EC 3294 Manes and Tails Organization Vol #: 17
EC 3295 Humanity Vol #: 17
EC 3296 Mrs. Rochelle Abrams Vol #: 17
EC 3297 Mr. Justin Shull Vol #: 17
EC 3298 Mrs. Karen Blumensaadt Vol #: 17
EC 3299 Mrs. Amy Traxler Vol #: 17
EC 3300 Mr. George Shrewsbury Vol #: 17
EC 3301 Ms. Jacqueline Burdi Vol #: 17
EC 3302 Mrs. Kelly Ohl Vol #: 17
EC 3303 Dr. Marcia Weinstein Vol #: 17
EC 3304 Licensed Veterinary Technician Vol #: 17
EC 3305 Mrs. Kristina Muck Vol #: 17
EC 3306 Mrs. Eve Bieber Vol #: 17
EC 3307 Ms. Sherry Arnold Vol #: 17
EC 3308 Ms. Cherie Rachel Vol #: 17
EC 3309 Ms. Barbara Lochte Vol #: 17
EC 3310 Ms. Kelly Kramer Vol #: 17
EC 3311 Ms. Kathleen Lawton Vol #: 17
EC 3312 Ms. Jennifer Inga Vol #: 17
EC 3313 Mr. shannon abernathy Vol #: 17
EC 3314 Miss. Lauren Barker Vol #: 17
EC 3315 Ms. LaRue Moore Vol #: 17
EC 3316 Dr. Alberto Rutger Vol #: 17
EC 3317 University of South Florida Vol #: 17
EC 3318 Dr. Laura Johnson Vol #: 17
EC 3319 Mrs. Leslie Seki Vol #: 17
EC 3320 Ms. Beverlee Goynes Vol #: 17
EC 3321 Mrs. Elizabeth Day Vol #: 17
EC 3322 Mrs. Marian McAleenan Vol #: 17
EC 3323 Mrs. Lisa Campbell Vol #: 17
EC 3324 Ms. Joanne O Regan Vol #: 17
EC 3325 Ms. Luiza Grunebaum Vol #: 17
EC 3326 Mrs. Kelli Cool Vol #: 17
EC 3327 Ms. Kristie O'Keefe Vol #: 17
EC 3328 Ms. Jill Anderson Vol #: 17
EC 3329 peta Vol #: 17
EC 3330 Ms. Carmela Egitto Vol #: 17
EC 3331 Ms. Lisa Stewart Vol #: 17
EC 3332 Mrs. Katherine Boccuzzi Vol #: 17
EC 3333 Mrs. kathrina hardman Vol #: 17
EC 3334 Ms. Lynn Ready Vol #: 17
EC 3335 Scripps Institution of Oceanography Vol #: 17
EC 3336 Mrs. Laurie Saggan Vol #: 17
EC 3337 Mr. Dennis Amaya Vol #: 17
EC 3338 Ms. Laurie Rando Vol #: 17
EC 3339 Ms. Bryan Kelley Vol #: 17
EC 3340 Ms. Lynda Nelms Vol #: 17
EC 3341 Mrs. Harriette Frank Vol #: 17
EC 3342 Mr. Manuel Otero Vol #: 17
EC 3343 Dr. MIchael Selig Vol #: 17
EC 3344 Mrs. Helen Bilowus Vol #: 17
EC 3345 Ms. Melanie Gong Vol #: 17
EC 3346 Ms. Mary Nell Bryan Vol #: 17
EC 3347 Ms. Michelle Kruse-Crocker Vol #: 17
EC 3348 Ms. Jill Strathdee Vol #: 17
EC 3349 Ms. Beverly Rae Vol #: 17
EC 3350 Ms. Carla Morin Vol #: 17
EC 3351 Mr. Eric Gilmartin Vol #: 17
EC 3352 b sachau Vol #: 17
EC 3353 Mrs. mandy corder Vol #: 17
EC 3354 n/a Vol #: 17
EC 3355 none Vol #: 17
EC 3356 Mrs. MICHELLE UNGER Vol #: 17
EC 3357 Mrs. Cristina Williamson Vol #: 17
EC 3358 Ms. J D Vol #: 17
EC 3359 Mr. Jose Ricardo Bondoc Vol #: 17
EC 3360 Mrs. Lisa Dillow Vol #: 17
EC 3361 Mrs. Theresa Carlson Vol #: 17
EC 3362 Ms. Karen Bacon Vol #: 17
EC 3363 Mrs. Nancy Beavers Vol #: 17
EC 3364 Ms. Michele Koskinen Vol #: 17
EC 3365 Miss. Marni Schmid Vol #: 17
EC 3366 Miss. Marcella Mirata Vol #: 17
EC 3367 Ms. Marci De Sart Vol #: 17
EC 3368 Miss. Lisa Johnson Vol #: 17
EC 3369 Dr. Colette Erickson Vol #: 17
EC 3370 Miss. Magaly Sandoval Vol #: 17
EC 3371 Ms. Marilie Sage Vol #: 17
EC 3372 Mrs. Laura Herndon Vol #: 17
EC 3373 Ms. Cynthia Kucera Vol #: 17
EC 3374 Ms. amalia zarranz Vol #: 17
EC 3375 Ms. Kim Johnson Vol #: 17
EC 3376 Mrs. Kelli Wallace Vol #: 17
EC 3377 WSPA Vol #: 17
EC 3378 WSPA, Best Friends, IFAW, etc. Vol #: 17
EC 3379 Mrs. Patricia Scanlon Vol #: 17
EC 3380 Ms. Linda Nicholas Vol #: 17
EC 3381 Mrs. James Denison Vol #: 17
EC 3382 Mrs. Patricia Maisonnave Vol #: 17
EC 3383 Miss. Elena Lemmo Vol #: 17
EC 3384 Miss. Bo Vega Vol #: 17
EC 3385 Mrs. Christy Smith Vol #: 17
EC 3386 Miss. Lauren Barker Vol #: 17
EC 3387 Ms. Deborah Martin Vol #: 17
EC 3388 Mr. Nigel Sawyer Vol #: 17
EC 3389 Ms. NK Acevedo Vol #: 17
EC 3390 Mrs. nancy walker Vol #: 17
EC 3391 Critter Corner Pet Supplies Vol #: 17
EC 3392 Mrs. Mary Zack Vol #: 17
EC 3393 Mr. Robert F Vol #: 17
EC 3394 Ms. Beverly Fannin Vol #: 17
EC 3395 Ms. Juliane Kaiss Vol #: 17
EC 3396 Ms. Samantha Grieves Vol #: 17
EC 3397 Mrs. Roberta Thurmond Vol #: 17
EC 3398 Housewife Vol #: 17
EC 3399 Mrs. Marie Kovar Vol #: 17
EC 3400 Ms. Jane Clifford Vol #: 17
2004E-0314 Patent Extension for Spiriva HandiHaler (tiotropium bromide inhalation powder), U.S. Patent No. 5,610,163
LET 7 U.S. Patent and Trademark Office to Boerhinger Ingelheim Corporation Vol #: 1
2004E-0389 Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
LET 6 U.S. Patent and Trademark Office to Morgan Lewis & Bockius, LLP Vol #: 1
2005E-0258 Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
LET 4 U.S. Patent and Trademark Office to Buchanan Ingersoll PC Vol #: 1
2005N-0105 Proposal to Debar James T. Kimball; Notice of Opportunity for Hearing
LET 2 FDA/DDM to James T. Kimball Vol #: 1
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
EREG 1 B. Sachau Vol #: 7
EREG 2 C. J. D. Watch Vol #: 7
2006D-0413 Guidance for Industry: Blue Bird Medicated Feed Labels
C 2 National Grain and Feed Association Vol #: 1
2007E-0046 Patent Extension Application for ZILMAX (zilpaterol hydrochloride), U.S. Patent No. 4,900,735
APP 1 Intervet Inc. Vol #: 1
LET 1 U.S. Patent and Trademark Office to FDA/CDER (HFD-7) Vol #: 1
2007N-0016 Sentinel Network To Promote Medical Product Safety
EAPE 95 Dombrowski, Cathy Vol #: 1
EAPE 96 Lagarenne, Paul Vol #: 1
EAPE 97 Hornbuckle, Ken Vol #: 1
EAPE 98 Peddicord, Doug Vol #: 1
EAPE 99 Lieberman, Michael Vol #: 1
EAPE 100 Ward, Steven Vol #: 1
EAPE 101 Blum, Michael Vol #: 1
EAPE 102 Gupta, Tanuj Vol #: 1
EAPE 103 Klein, Bill Vol #: 1
2007P-0044 Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
ACK 1 FDA/DDM to Public Citizen's Health Research Group Vol #: 1
CP 1 Public Citizen's Health Research Group Vol #: 1

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