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Dockets Management
Dockets Entered On March 20, 2006
Table of Contents
Docket # Title
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006P-0125 Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons
2006P-0126 Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie".
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 322 Archer Daniels Midland Company Vol #: 254
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 17254 XPL Innovations, Inc. Vol #: 158
LET 17255 Fitness Labs Vol #: 158
LET 17256 NOW Foods Vol #: 158
LET 17257 NOW Foods Vol #: 158
LET 17258 NOW Foods Vol #: 158
LET 17259 NOW Foods Vol #: 158
LET 17260 NOW Foods Vol #: 158
LET 17261 NDS Nutritional Products, Inc. Vol #: 158
LET 17262 NDS Nutritional Products, Inc. Vol #: 158
LET 17263 NDS Nutritional Products, Inc. Vol #: 158
LET 17264 Fitness Labs Vol #: 158
LET 17265 Fitness labs Nutrition Corporation Vol #: 158
LET 17266 Vergance Vol #: 158
LET 17267 Bionorica LLC Vol #: 158
LET 17268 Source Naturals Vol #: 158
LET 17269 Eu Yan Sang(Hong Kong) Limited Vol #: 158
LET 17270 RBC Life Sciences Vol #: 158
LET 17271 Solstice Medicine Company Vol #: 158
LET 17272 Enzymatic Therapy Vol #: 158
LET 17273 Enzymatic Therapy Vol #: 158
LET 17274 Enzymatic Therapy Vol #: 158
LET 17275 Nutriex,L.C. Vol #: 158
LET 17276 Herbalife International of America, Inc. Vol #: 158
LET 17277 Sante Active, Inc. Vol #: 158
LET 17278 Sante Active, Inc. Vol #: 158
LET 17279 AdvoCare International, L.P. Vol #: 158
LET 17280 AdvoCare International, L.P. Vol #: 158
LET 17281 Bio-Botanica, Inc. Vol #: 158
LET 17282 Bio-Botanica, Inc. Vol #: 158
LET 17283 Bio-Botanica, Inc. Vol #: 158
LET 17284 Bio-Botanica, Inc. Vol #: 158
LET 17285 NBTY Inc. Vol #: 158
LET 17286 NBTY Inc. Vol #: 158
LET 17287 NBTY Inc. Vol #: 158
LET 17288 NBTY Inc. Vol #: 158
LET 17289 NBTY Inc. Vol #: 158
LET 17290 NBTY Inc. Vol #: 158
LET 17291 NBTY Inc. Vol #: 158
LET 17292 NBTY Inc. Vol #: 158
LET 17293 NBTY Inc. Vol #: 158
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 3239 I Morales Vol #: 61
C 3240 J. Rim Vol #: 61
C 3241 R. Castellanos Vol #: 61
C 3242 S. Tweed Vol #: 61
C 3243 R. Landozuin Vol #: 61
C 3244 R. Lowen, MD Vol #: 61
C 3245 J. Carter Vol #: 61
C 3246 D. Carter Vol #: 61
C 3247 G. Shima, MD Vol #: 61
C 3248 K. Phelan Vol #: 61
C 3249 A. Welch Vol #: 61
C 3250 J. Palmer Vol #: 61
C 3251 S. Churchill Vol #: 61
C 3252 J. Sinner Vol #: 61
C 3253 J. Andritzakis Vol #: 61
C 3254 S. Sumian Vol #: 61
C 3255 K. Margolin, MD Vol #: 61
C 3256 D. Phillips Vol #: 61
C 3257 M. Lindlow Vol #: 61
C 3258 A. Woessner Vol #: 61
C 3259 J. Mead, MD Vol #: 61
C 3260 P. Linville Vol #: 61
C 3261 P. Smith Vol #: 61
C 3262 M. Bruce Vol #: 61
C 3263 C. Hallock Vol #: 61
C 3264 E. Beckerstrom Vol #: 61
C 3265 T. Peela Vol #: 61
C 3266 S. Savery Vol #: 61
C 3267 Dr. M. Giddens Vol #: 61
C 3268 E. Frankensteen Vol #: 61
C 3269 T. Weaver Vol #: 61
C 3270 C. Winstead Vol #: 61
C 3271 B. Sutherland Vol #: 61
C 3272 I. Rubio Vol #: 61
C 3273 D. Phipps Vol #: 61
C 3274 M. Kutson Vol #: 61
C 3275 B. Jeffords Vol #: 61
C 3276 M. Curist Vol #: 61
C 3277 M. Espinosa Vol #: 61
C 3278 M. Espinosa Vol #: 61
C 3279 D. Daane Vol #: 61
C 3280 E. Andrews Vol #: 61
C 3281 M. Hoeksema Vol #: 61
C 3282 B. Bettega Vol #: 61
C 3283 V. Williamson Vol #: 61
C 3284 J. Tacheny Vol #: 61
C 3285 C. Erlandsson Vol #: 61
C 3286 M. Smith Vol #: 61
C 3287 F. Ratcliffe Vol #: 61
C 3288 M. Parana Vol #: 61
C 3289 P. Creadon Vol #: 61
C 3290 M. O'Neill Vol #: 61
C 3291 L. Frebinz Vol #: 61
C 3292 N. Barbera Vol #: 61
C 3293 C. Hall Vol #: 61
C 3294 M. Jones Vol #: 61
C 3295 C. Feaster Vol #: 61
C 3296 M. Willis Vol #: 61
C 3297 E. Coe Vol #: 61
C 3298 T. Dibbs Vol #: 61
C 3299 B. King Vol #: 61
C 3300 G. Delia Vol #: 61
C 3301 B. Whitkop, R.Ph Vol #: 61
C 3302 R. Loficcolo Vol #: 62
C 3303 J. Osborn Vol #: 62
C 3304 D. McCabe Vol #: 62
C 3305 D. McCabe Vol #: 62
C 3306 S. LaDoe Vol #: 62
C 3307 M. McCormick Vol #: 62
C 3308 W. Blomquist Vol #: 62
C 3309 C. Hearst Vol #: 62
C 3310 C. Hearst Vol #: 62
C 3311 P. Godby Vol #: 62
C 3312 C. HEarst Vol #: 62
C 3313 C. Hearst Vol #: 62
C 3314 G. Hall Vol #: 62
C 3315 N. DeLong Vol #: 62
C 3316 D. Giel Vol #: 62
C 3317 B. Cissell Vol #: 62
C 3318 K. Hall Vol #: 62
C 3319 D. Kleinschuster Vol #: 62
C 3320 B. Cary Vol #: 62
C 3321 J. Costan Vol #: 62
C 3322 J. Weiss Vol #: 62
C 3323 J. Nickholds Vol #: 62
C 3324 V. Bunton Vol #: 62
C 3325 S. Dega Vol #: 62
C 3326 E. Nemeth Vol #: 62
C 3327 S. Oman Vol #: 62
C 3328 C. Johnson Vol #: 62
C 3329 P. Hutt Vol #: 62
C 3330 M. LArkin Vol #: 62
C 3331 P. Danemayer Vol #: 62
C 3332 A. Baldwin Vol #: 62
C 3333 K. Kluth Vol #: 62
C 3334 S. Nettum Vol #: 62
C 3335 E. Rial Vol #: 62
C 3336 P. Schrimps Vol #: 62
C 3337 J. Jarmusch Vol #: 62
C 3338 M. Krause Vol #: 62
C 3339 D. Edelberg, M.D. Vol #: 62
C 3340 B. Hummel Vol #: 62
C 3341 V. Prouin Vol #: 62
C 3342 D. Barutha Vol #: 62
C 3343 H. Lindemann Vol #: 62
C 3344 N. Michels Vol #: 62
C 3345 N. Oliphant Vol #: 62
C 3346 K. Wall Vol #: 62
C 3347 M. Gregory Vol #: 62
C 3348 O. Baker Vol #: 62
C 3349 D. Hellman Vol #: 62
C 3350 H. McDaniel Vol #: 62
C 3351 E. Pentecost Vol #: 62
C 3352 E. Lowers Vol #: 62
C 3353 P. Giannetti Vol #: 62
C 3354 I. Johnson Vol #: 62
C 3355 G. Angemi Vol #: 62
C 3356 K. Bushaw Vol #: 62
C 3357 H. Grant Vol #: 62
C 3358 R. Aarsh Vol #: 62
C 3359 N. Charleson Vol #: 62
C 3360 J. Karnell Vol #: 62
C 3361 E. Yasarhely Vol #: 62
C 3362 S. Fujimoto Vol #: 62
C 3363 M. Reimers Vol #: 62
C 3364 J. Goodrich Vol #: 62
C 3365 W. Smith Vol #: 62
C 3366 C. Gonzales Vol #: 62
C 3367 C. Gonzales Vol #: 62
C 3368 N. Williams Vol #: 62
C 3369 M. Rockamore Vol #: 62
C 3370 D. Harris Vol #: 62
C 3371 E. Beilman Vol #: 62
C 3372 J. Colby Vol #: 62
C 3373 S. Wolford Vol #: 62
C 3374 S. Randozzo Vol #: 62
C 3375 A. Wordworth Vol #: 62
C 3376 R. Aarsh Vol #: 62
C 3377 P. Ford Vol #: 62
C 3378 P. Ford Vol #: 62
C 3379 M. Spellman Vol #: 62
C 3380 L. Siqueira Vol #: 62
C 3381 M. Hilton Vol #: 62
C 3382 H. Kolodshey Vol #: 62
C 3383 L. Styczynski Vol #: 62
C 3384 E. Ruddell Vol #: 62
C 3385 I. Kerrivan Vol #: 62
C 3386 G. Johnson Vol #: 62
C 3387 D. Mathias Vol #: 62
C 3388 S. Marlowe Vol #: 62
C 3389 L. Alvarez Vol #: 62
C 3390 J. Abdai Vol #: 62
C 3391 J. Gehrisch Vol #: 62
C 3392 R. Mehnik Vol #: 62
C 3393 S. Clair Vol #: 62
C 3394 B. Helzner Vol #: 62
C 3395 J. Witten Vol #: 62
C 3396 P. Farnham Vol #: 62
C 3397 K. Cliburn Vol #: 62
C 3398 M. Jepson Vol #: 62
C 3399 S. Pepple Vol #: 62
C 3400 W. Young Vol #: 62
C 3401 D. Wieneke Vol #: 62
C 3402 D. Stock Vol #: 62
C 3403 N. Cole Vol #: 62
C 3404 N. Alexander Vol #: 62
C 3405 C. Wastal Vol #: 62
C 3406 K. Sullivan Vol #: 62
C 3407 D. Karably Vol #: 62
C 3408 D. Cline, M.D. Vol #: 62
C 3409 C. Hause Vol #: 62
C 3410 S. Meraj Vol #: 62
C 3411 S. Luke Vol #: 62
C 3412 J. Davidson Vol #: 62
C 3413 P. Boye Vol #: 62
C 3414 J. McKenzee Vol #: 62
C 3415 Eligible Vol #: 62
C 3416 B. Phillips Vol #: 62
C 3417 R. Pessin Vol #: 62
C 3418 C. Price Vol #: 62
C 3419 E. Marg Vol #: 62
C 3420 K. Wright Vol #: 62
C 3421 B. McMenamy Vol #: 62
C 3422 A. Rosplock Vol #: 62
C 3423 M. Witecki Vol #: 62
C 3424 K. Doheny Vol #: 62
C 3425 J. Trenary Vol #: 62
C 3426 A. Mahaffey Vol #: 62
C 3427 I. Mongrain Vol #: 62
C 3428 B. Covyeau Vol #: 62
C 3429 B. Covyeau Vol #: 62
C 3430 D. Stewart Vol #: 62
C 3431 K. Johnson Vol #: 62
C 3432 A. Stewart Vol #: 62
C 3433 N. Smith Vol #: 62
C 3434 B. Cortabitarte Vol #: 62
C 3435 P. Butterfield Vol #: 62
C 3436 F. Riedel Vol #: 62
C 3437 E. Raymond Vol #: 62
C 3438 L. Phelan Vol #: 62
C 3439 J. Hopkins Vol #: 62
C 3440 M. Chaney Vol #: 62
C 3441 J. McCallen Vol #: 62
C 3442 A. Hansen Vol #: 62
C 3443 E. Smith Vol #: 62
C 3444 J. DiQuattro Vol #: 62
C 3445 R. Patton Vol #: 62
C 3446 K. Jurich Vol #: 62
C 3447 L. Paxton Vol #: 62
C 3448 J. Michel, MD Vol #: 62
C 3449 C. Miller Vol #: 62
C 3450 J. Montoya Vol #: 62
C 3451 A. Montoya Vol #: 62
C 3452 C. Jaffe Vol #: 62
C 3453 D. Drew Vol #: 62
C 3454 D. Hardy Vol #: 62
C 3455 M. Durst Vol #: 62
C 3456 F. Leuschen Vol #: 62
C 3457 J. Beima Vol #: 62
C 3458 G. Mammana Vol #: 62
C 3459 C. Youman Vol #: 62
C 3460 L. Menas Vol #: 62
C 3461 M. Cawley Vol #: 62
C 3462 D. Yateman Vol #: 62
C 3463 J. West Vol #: 62
C 3464 S. Halbert, MD Vol #: 62
C 3465 C. Olson Vol #: 62
C 3466 A. Hessler Vol #: 62
C 3467 R. Scheffer Vol #: 62
C 3468 G. Jasher Vol #: 62
C 3469 E. Siqueioca Vol #: 62
C 3470 T. Borkore Vol #: 62
C 3471 E. Helmuth Vol #: 62
C 3472 P. Lewis Vol #: 62
C 3473 R. Arias, MD Vol #: 62
C 3474 E. Clair Vol #: 62
C 3475 Eligible Vol #: 62
C 3476 S. Schmidt Vol #: 62
C 3477 D. Dowe Vol #: 62
C 3478 J. Riley Vol #: 62
C 3479 E. Wolman Vol #: 62
C 3480 C. Rossezet Vol #: 62
C 3481 E. Runte, MD Vol #: 62
C 3482 S. Halbert, MD Vol #: 62
C 3483 S. Abston Vol #: 62
C 3484 L. McCendon Vol #: 62
C 3485 J. Wilson Vol #: 62
C 3486 R. Bailey Vol #: 62
C 3487 G. Voorhees Vol #: 62
C 3488 Eligible Vol #: 62
C 3489 K. Blanchard, PhD., MD Vol #: 62
C 3490 Eligible Vol #: 62
C 3491 K. Havens Vol #: 62
C 3492 S. Haske Vol #: 62
C 3493 S. Jewett Vol #: 62
C 3494 R. Woodcock Vol #: 62
C 3495 S. Walker Vol #: 62
C 3496 K. McEntee Vol #: 62
C 3497 B. Lee Vol #: 62
C 3498 S. Mahana Vol #: 62
C 3499 S. Petty Vol #: 62
C 3500 C. Wood Vol #: 62
C 3501 K. Chaney Vol #: 62
C 3502 D. Charland Vol #: 62
C 3503 T. Simon Vol #: 62
C 3504 T. Hadfield Vol #: 62
C 3505 D. Schoeneman Vol #: 62
C 3506 C. Farley Vol #: 62
C 3507 E. Angelett Vol #: 62
C 3508 R. Silva Vol #: 62
C 3509 V. Terry Vol #: 62
C 3510 L. Hall Vol #: 62
C 3511 E. Carr Vol #: 62
C 3512 B. Cortabitarte Vol #: 62
C 3513 G. Bowman Vol #: 62
C 3514 A. Hill Vol #: 62
C 3515 Eligible Vol #: 62
C 3516 J. Morton Vol #: 62
C 3517 N. Lutz Vol #: 62
C 3518 C. Platania Vol #: 62
C 3519 K. Swiger Vol #: 62
C 3520 L. Landrum Vol #: 62
C 3521 R. Calderon Vol #: 62
C 3522 D. Fincher Vol #: 62
C 3523 K. Perrill Vol #: 62
C 3524 D. Gray Vol #: 62
C 3525 G. Vanzant Vol #: 62
C 3526 K. Willis Vol #: 62
C 3527 B. Cimini Vol #: 62
C 3528 V. Horsley Vol #: 62
C 3529 D. Maria Vol #: 62
C 3530 J. Robertson Vol #: 62
C 3531 V. Barber Vol #: 61
C 3532 M. Clauer Vol #: 62
C 3533 B. Mattingly Vol #: 62
C 3534 C. Bluestein Vol #: 62
C 3535 S. Fenske Vol #: 62
C 3536 M. Morris Vol #: 62
C 3537 P. Bell Vol #: 62
C 3538 F. Andrews Vol #: 62
C 3539 B. Hogan Vol #: 62
C 3540 M. Ames Vol #: 62
C 3541 I. Iyer Vol #: 62
C 3542 D. Beabold Vol #: 62
C 3543 J. Rockwell Vol #: 62
C 3544 B. Ken Vol #: 62
C 3545 V. Montgomery Vol #: 62
C 3546 M. Kraus Vol #: 62
C 3547 R. Sullivan Vol #: 62
C 3548 M. Menn Vol #: 62
C 3549 J. Franscioni Vol #: 62
C 3550 D. Carson Vol #: 62
C 3551 G. Sparks Vol #: 62
C 3552 J. Heikel Vol #: 62
C 3553 R. DiMaggio Vol #: 62
C 3554 J. Edwards Vol #: 62
C 3555 B. Diehl Vol #: 62
C 3556 Dorothy Drachman Vol #: 63
C 3557 M. Noble Vol #: 63
C 3558 M. Pepper Vol #: 63
C 3559 S. Snyder Vol #: 63
C 3560 C. Sierakowski Vol #: 63
C 3561 K. Hood Vol #: 63
C 3562 S. Azer Vol #: 63
C 3563 P. BArrett Vol #: 63
C 3564 P. Mee Vol #: 63
C 3565 D. Lase Vol #: 63
C 3566 L. Moore Vol #: 63
C 3567 M. Donaldson Vol #: 63
C 3568 R. Shepherd Vol #: 63
C 3569 B. Higgins Vol #: 63
C 3570 N. Oxman Vol #: 63
C 3571 J. Hogan Vol #: 63
C 3572 K. Allan Vol #: 63
C 3573 R. Kirkland Vol #: 63
C 3574 W. Williams Vol #: 63
C 3575 P. Wise Vol #: 63
C 3576 E. Freitas Vol #: 63
C 3577 R. Glaudinie Vol #: 63
C 3578 P. LeGare Vol #: 63
C 3579 R. Loughin Vol #: 63
C 3580 L. Williams Vol #: 63
C 3581 R. Albis Vol #: 63
C 3582 M. McHugh Vol #: 63
C 3583 K. Lich Vol #: 63
C 3584 J. Devine Vol #: 63
C 3585 D. Schultz Vol #: 63
C 3586 S. Davis Vol #: 63
C 3587 J. Stavols Vol #: 63
C 3588 J. Stavols Vol #: 63
C 3589 C. Steinberg Vol #: 63
C 3590 J. Roseuear Vol #: 63
C 3591 D. Pfleger Vol #: 63
C 3592 J. Semmens Vol #: 63
C 3593 C. Harman Vol #: 63
C 3594 E. Born Vol #: 63
C 3595 B. Mueller Vol #: 63
C 3596 T. Myers Vol #: 63
C 3597 G. Ladislas, FNP Vol #: 63
C 3598 T. Ward Vol #: 63
C 3599 M. Kistner Vol #: 63
C 3600 E. Miller Vol #: 63
C 3601 J. Stievers Vol #: 63
C 3602 J. Schulte Vol #: 63
C 3603 D. Webster Vol #: 63
C 3604 J. Goe Vol #: 63
C 3605 C. Brummer, MD Vol #: 63
C 3606 V. Ohen Vol #: 63
C 3607 Eligible Vol #: 63
C 3608 D. August Vol #: 63
C 3609 K. Memmesheimer Vol #: 63
C 3610 Eligible Vol #: 63
C 3611 Dr. Kessler Vol #: 63
C 3612 J. Sheerin Vol #: 63
C 3613 L. Lore Vol #: 63
C 3614 I. Hillman Vol #: 63
C 3615 L. Coroas Vol #: 63
C 3616 I. Canepa Vol #: 63
C 3617 Eligible Vol #: 63
C 3618 A. Zwicker Vol #: 63
C 3619 L. Caputo Vol #: 63
C 3620 J. Chappell Vol #: 63
C 3621 P. Arlon Vol #: 63
C 3622 L. Weber Vol #: 63
C 3623 P. Jones Vol #: 63
C 3624 B. Cox Vol #: 63
C 3625 J. Hypiel Vol #: 63
C 3626 S. Dyer Vol #: 63
C 3627 Eligible Vol #: 63
C 3628 M. Leo Vol #: 63
C 3629 K. McDonald Vol #: 63
C 3630 G. Plotkin Vol #: 63
C 3631 R. Patterson Vol #: 63
C 3632 J. Padtke Vol #: 63
C 3633 M. Mehrer Vol #: 63
C 3634 C. Anderson Vol #: 63
C 3635 M. ALexander Vol #: 63
C 3636 M. Jamerson Vol #: 63
C 3637 L. Lehman Vol #: 63
C 3638 A. Watts Vol #: 63
C 3639 R. Glynn Vol #: 63
C 3640 A. Filsinger Vol #: 63
C 3641 S. Urban Vol #: 63
C 3642 D. Klemp Vol #: 63
C 3643 S. Fuchs Vol #: 63
C 3644 S. Thomas Vol #: 63
C 3645 J. Kinney Vol #: 63
C 3646 M. Brown Vol #: 63
C 3647 C. Brown Vol #: 63
C 3648 S. Patty Vol #: 63
C 3649 S. Nensel Vol #: 63
C 3650 M. Pennington Vol #: 63
C 3651 E. Altemose Vol #: 63
C 3652 S. Reimann Vol #: 63
C 3653 D. James Vol #: 63
C 3654 S. Erhardt Vol #: 63
C 3655 B. Pratt Vol #: 63
C 3656 L. Hightower Vol #: 63
C 3657 B. Smart Vol #: 63
C 3658 M. Brown Vol #: 63
C 3659 D. O'Dell Vol #: 63
C 3660 B. Annan Vol #: 63
C 3661 S. Reid Vol #: 63
C 3662 L. Campbell Vol #: 63
C 3663 S. Clark Vol #: 63
C 3664 E. Wilson Vol #: 63
C 3665 V. Cipolla Vol #: 63
C 3666 J. Greene Vol #: 63
C 3667 R. Metrinko Vol #: 63
C 3668 H. Lander Vol #: 63
C 3669 L. Szymanski Vol #: 63
C 3670 C. Kates Vol #: 63
C 3671 C. Terrell Vol #: 63
C 3672 J. Crist Vol #: 63
C 3673 J. Clayton Vol #: 63
C 3674 E. Crouse Vol #: 63
2006P-0125 Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn 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
2006P-0126 Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie".
ACK 1 HFA-305 to Richard S. Wyde, Esq. & Roberta Kraus Wyde, MPH, PhD Vol #: 1
CP 1 Richard S. Wyde, Esq. & Roberta Kraus Wyde, MPH, PhD Vol #: 1

Page created on April 27, 2006 dp

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