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Dockets Management
Dockets Entered On March 31, 2006
Docket # Title
1976N-0052N OTC Nasal Decongestants
2003E-0030 Patent Term Extension Application for FASLODEX No. 4,659,516
2004E-0427 Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone
Replacement Therapy Drugs
2006P-0072 ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL.
2006P-0144 delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and
therefore suibable for ANDA
2006P-0145 ANDA suitability for Gemcitabine
2006P-0146 Request for Promulgation of an Amended Regulation for Prescription Drug Advertising to Establish Separate Criteria
for Practitioner-Directed and Consumer-Directed Advertising and to Establish a Standi
2006P-0147 Determine whether Risperdal M Tab (Risperidone) Orally Disintegrating Tablets, 3 mg and 4 mg (NDA No. 21-444),
was voluntarily withdrawn or withheld from sale for safety or efficacy reasons
1976N-0052N OTC Nasal Decongestants
CP 20 Wyeth Vol #: 87
2003E-0030 Patent Term Extension Application for FASLODEX No. 4,659,516
LET 4 HFD-5 to U.S. Patent and Trademark Office Vol #: 1
2004E-0427 Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
LET 2 HFD-5 to U.S. Patent and Trademark Office Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical
Hormone Replacement Therapy Drugs
C 4375 G. Zimmermann Vol #: 69
C 4376 C. Bingham Vol #: 69
C 4377 G. Schovan Vol #: 69
C 4378 S. Gilman Vol #: 69
C 4379 M. Vieyra Vol #: 69
C 4380 V. Garske Vol #: 69
C 4381 R and C Williams Vol #: 69
C 4382 N. Halpin Vol #: 69
C 4383 A. Stahlberg Vol #: 69
C 4384 C. Turner Vol #: 69
C 4385 J. Montgomery Vol #: 69
C 4386 T. McCabe Vol #: 69
C 4387 K. Connolly Vol #: 69
C 4388 G. Cass Vol #: 69
C 4389 J. Stearns Vol #: 69
C 4390 C. Nordling Vol #: 69
C 4391 K. Brown Vol #: 69
C 4392 L. Vandiver Vol #: 69
C 4393 S. Starry Vol #: 69
C 4394 A. Hausner Vol #: 69
C 4395 T. Long Vol #: 69
C 4396 M. Cox Vol #: 69
C 4397 L. Wrobleski Vol #: 69
C 4398 D. Kleinbak Vol #: 69
C 4399 C. Rock Vol #: 69
C 4400 J. Mullen Vol #: 69
C 4401 J. Blackford Vol #: 69
C 4402 G. Billings Vol #: 69
C 4403 J. C. Wavra Vol #: 69
C 4404 J. Anderson Vol #: 69
C 4405 D. Merritt Vol #: 69
C 4406 J. Bernier Vol #: 69
C 4407 S. McKain Vol #: 69
C 4408 R. Bartug Vol #: 69
C 4409 S. Ostlund Vol #: 69
C 4410 B. Webber Vol #: 69
C 4411 S. Walker Vol #: 69
C 4412 J. Deich Vol #: 69
C 4413 C. Lambert Vol #: 69
C 4414 N. Doan Vol #: 69
C 4415 D. Morton Vol #: 69
C 4416 C. Gordon Vol #: 69
C 4417 K. King Vol #: 69
C 4418 A. King Vol #: 69
C 4419 M. Flynn Vol #: 69
C 4420 J. Kebler Vol #: 69
C 4421 M. Tollstrup Vol #: 69
C 4422 S. Wing Vol #: 69
C 4423 D. Anderson Vol #: 69
C 4424 C. Betterley Vol #: 69
C 4425 J. Steiner Vol #: 69
C 4426 C. Henke Vol #: 77
C 4427 B. Levy Vol #: 77
C 4428 L. Morgan Vol #: 77
C 4429 D. Campbell Vol #: 77
C 4430 C. Heuer Vol #: 77
C 4431 D. Piel Vol #: 77
C 4432 D. Wunderle Vol #: 77
C 4433 S. Hunter Vol #: 77
C 4434 D. Weidema Vol #: 77
C 4435 M. Walrath Vol #: 77
C 4436 J. Roberts Vol #: 77
C 4437 J. Bowden Vol #: 77
C 4438 A. Ruffin Vol #: 77
C 4439 C. Bush Vol #: 77
C 4440 J. Untz Vol #: 77
C 4441 L. Rueth Vol #: 77
C 4442 C. Peakin Vol #: 77
C 4443 U. Muench Vol #: 77
C 4444 D. Gerndt Vol #: 77
C 4445 S. Castelli Vol #: 77
C 4446 D. Mulhall Vol #: 77
C 4447 S. Pincs Vol #: 77
C 4448 Ms Gad Vol #: 77
C 4449 C. Slotnick Vol #: 77
C 4450 S. Luccini Vol #: 77
C 4451 D. Kubin Vol #: 77
C 4452 N. Brown Vol #: 77
C 4453 C. Ponto Vol #: 77
C 4454 L. Roman Vol #: 77
C 4455 D. Rey Vol #: 77
C 4456 D. Rosalind Vol #: 77
C 4457 A. Hargrave Vol #: 77
C 4458 S. Davidson Vol #: 77
C 4459 D. Seiler Vol #: 77
C 4460 N. Arredondo Vol #: 77
C 4461 M. Hoke Vol #: 77
C 4462 D. Alzola Vol #: 77
C 4463 M. Froehlich Vol #: 77
C 4464 C. Lueckenotte Vol #: 77
C 4465 J. Wallis Vol #: 77
C 4466 E. Averill Vol #: 77
C 4467 E. Schatz Vol #: 77
C 4468 E. Farhie Vol #: 77
C 4469 P. Waller Vol #: 77
C 4470 E. Chiang Vol #: 77
C 4471 R. Stuffle Vol #: 77
C 4472 F. Bucher Vol #: 77
C 4473 S. Oicles Vol #: 77
C 4474 N. Dillon Vol #: 77
C 4475 B. Harmon Vol #: 77
C 4476 M. Donhoff Vol #: 77
C 4477 L. Donato Vol #: 77
C 4478 N. Apgar Vol #: 77
C 4479 C. Houge Vol #: 77
C 4480 D. Robinson Vol #: 77
C 4481 C. Colwell Vol #: 77
C 4482 C. Rosenfield Vol #: 77
C 4483 S. Upshaw Vol #: 77
C 4484 J. Fredyma Vol #: 77
C 4485 J. Genovese Vol #: 77
C 4486 P. Simon Vol #: 77
C 4487 C. Rosa Vol #: 77
C 4488 C. Larsen Vol #: 77
C 4489 Giulia Ehrich Vol #: 77
C 4490 C. Dunham Vol #: 77
C 4491 S. Harris Vol #: 77
C 4492 Eligible Vol #: 77
C 4493 M. Mahammed Vol #: 77
C 4494 F. Lovejoy Vol #: 77
C 4495 C. Melton Vol #: 77
C 4496 L. Mortensen Vol #: 77
C 4497 J. Vranesh Vol #: 77
C 4498 S. Boynton Vol #: 77
C 4499 S. Sunday Vol #: 77
C 4500 D. Peat, MD Vol #: 77
C 4501 R. Shubeck Vol #: 77
C 4502 K. Crewse Vol #: 77
C 4503 C. Peat Vol #: 77
C 4504 S. McEvilly Vol #: 77
C 4505 V. Moore Vol #: 77
C 4506 C. Witkowski Vol #: 77
C 4507 A. Miller Vol #: 77
C 4508 J. Barnes Vol #: 77
C 4509 N. Haines Vol #: 77
C 4510 A. Stack Vol #: 77
C 4511 L. Salamina Vol #: 77
C 4512 T. Finnigan Vol #: 77
C 4513 C. Powell Vol #: 77
C 4514 J. Martin Vol #: 77
C 4515 E. Gnotke Vol #: 77
C 4516 L. Brent Vol #: 77
C 4517 S. Battistello Vol #: 77
C 4518 M. Saile Vol #: 77
C 4519 M. Friedman Vol #: 77
C 4520 B. Bowers Vol #: 77
C 4521 B. Rosa Vol #: 78
C 4522 L. Howard Vol #: 78
C 4523 B. Bomer Vol #: 78
C 4524 S. Witten Vol #: 78
C 4525 L. Teal Vol #: 78
C 4526 V. Finstad Vol #: 78
C 4527 D. Mello Vol #: 78
C 4528 C. Cox Vol #: 78
C 4529 S. Freeman Vol #: 78
C 4530 P. Greene Vol #: 78
C 4531 Dr. Coats, D.O. Vol #: 78
C 4532 R. Gillis Vol #: 78
C 4533 A. McGrigg Vol #: 78
C 4534 K. Pollack Vol #: 77
2006P-0072 ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL.
WDL 1 Olsson,Frank and Weeda, P.C. Vol #: 1
2006P-0144 delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore
suibable for ANDA
ACK 1 HFA-305 to CUSTOpharm, Inc. Vol #: 1
2006P-0145 ANDA suitability for Gemcitabine
ACK 1 HFA-305 to Lachman Consultant Services, Inc. Vol #: 1
CP 1 Lachman Consultant Services, Inc. Vol #: 1
2006P-0146 Request for Promulgation of an Amended Regulation for Prescription Drug Advertising to Establish Separate Criteria for
Practitioner-Directed and Consumer-Directed Advertising and to Establish a Standi
ACK 1 HFA-305 to Wiley, Rein & Fielding L.L.P. Vol #: 1
CP 1 Coalition for Healthcare Communication Vol #: 1
2006P-0147 Determine whether Risperdal M Tab (Risperidone) Orally Disintegrating Tablets, 3 mg and 4 mg (NDA No. 21-444),
was voluntarily withdrawn or withheld from sale for safety or efficacy reasons
ACK 1 HFA-305 to Lachman Consultant Services, Inc. Vol #: 1
CP 1 Lachman Consultant Services, Inc. Vol #: 1

Page created on April 3, 2006 kk

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