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Dockets Management
Dockets Entered On July 27, 2006
Table of Contents
Docket # Title
2000D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers
2001N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0275 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems
2006E-0250 Patent Extension Application for SOLTAMOX (tamoxifen citrate for oral administration), U.S. Patent No. 6,127,425
2006M-0293 P050044 - Vitagel Surgical Hemostat - Approved 6/16/06
2006M-0294 P050017 - Zilver Vascular Stent - Approved 6/26/06
2006M-0295 P050014 - Fuji Computed Radiography Mammography Suite (FCRMS) - Approved 7/10/06
2006N-0276 Medical Devices; Immunology and Microbiology Devices; Classification of Fecal Calprotectin Immunological Test Systems
2006P-0052 Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
2006P-0205 Require Vitamin D be added to cereal-grain products
2000D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers
C 24 S DeMonte Vol #: 6
2001N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits
BKG 3 Background Material Vol #: 6
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 17942 M. Sample Vol #: 193
C 17943 R. Ennis Vol #: 193
C 17944 G. Stephens Vol #: 193
C 17945 K. Recudi Vol #: 193
C 17946 J. Kimelman Vol #: 193
C 17947 J. Kimelman Vol #: 193
C 17948 R. Masselas Vol #: 193
C 17949 S. Miller Vol #: 193
C 17950 D. Lucido Vol #: 193
C 17951 K. Bettger Vol #: 193
C 17952 C. Ashlock Vol #: 193
EMC 3322 C. Wise Vol #: 176
EMC 3323 G. Moncke Vol #: 176
EMC 3324 D. Sclar Vol #: 176
EMC 3325 D. Morrow Vol #: 176
EMC 3326 K. Snell Vol #: 176
EMC 3327 J. Mertens Vol #: 176
EMC 3328 K. Olander Vol #: 176
EMC 3329 T. Brown Vol #: 176
EMC 3330 M. Overman Vol #: 176
EMC 3331 C. Harris Vol #: 176
EMC 3332 D. Pettibone Vol #: 176
EMC 3333 H. Thomson Vol #: 176
EMC 3334 B. Evans Vol #: 176
EMC 3335 M. & R. Vol #: 176
EMC 3336 R. Miller Vol #: 176
EMC 3337 M. Overman Vol #: 176
EMC 3338 P. Ballingham Vol #: 176
EMC 3339 C. DeGroot Vol #: 176
EMC 3340 C. DeGroot Vol #: 176
EMC 3341 N. Taylor Vol #: 176
EMC 3342 C. Collins Vol #: 176
EMC 3343 C. Collins Vol #: 176
EMC 3344 C. DeGroot Vol #: 176
EMC 3345 C. Collins Vol #: 176
EMC 3346 G. Green Vol #: 176
EMC 3347 C. Yeagley Vol #: 176
EMC 3348 S. Singingtree Vol #: 176
EMC 3349 K. Bryson Vol #: 176
EMC 3350 S. Woodward Vol #: 176
EMC 3351 S. Woodward Vol #: 176
EMC 3352 B. Clemens Vol #: 176
EMC 3353 E. Foltz Vol #: 176
EMC 3354 C. DeGroot Vol #: 176
EMC 3355 A. Brockway Vol #: 176
EMC 3356 D. Jacob Vol #: 176
EMC 3357 C. DeGroot Vol #: 176
EMC 3358 E. Hay Vol #: 176
EMC 3359 R. Bryson Vol #: 176
EMC 3360 D. Painter Vol #: 176
EMC 3361 M. Hall Vol #: 176
EMC 3362 R. Schneider Vol #: 176
EMC 3363 M. Grindlinger Vol #: 176
EMC 3364 W. Brewer Vol #: 176
EMC 3365 J. Wright Vol #: 176
EMC 3366 L. Wine Vol #: 176
EMC 3367 Y. Brockdorf Vol #: 176
EMC 3368 S. Hennings Vol #: 176
EMC 3369 R. Cox Vol #: 176
EMC 3370 B. & L. Fry Vol #: 176
EMC 3371 A. Jacobi Vol #: 176
EMC 3372 M. Stein Vol #: 176
EMC 3373 M. Davenport Vol #: 176
EMC 3374 A. Hussein Vol #: 176
EMC 3375 J. McCourt Vol #: 176
EMC 3376 J. McCourt Vol #: 176
EMC 3377 M. Bentov Vol #: 176
EMC 3378 N. Nausbaum Vol #: 176
EMC 3379 K. Mervosh Vol #: 176
EMC 3380 K. Mervosh Vol #: 176
EMC 3381 S. Miller Vol #: 176
EMC 3382 C. Hawn Vol #: 176
EMC 3383 R. Freed Vol #: 176
EMC 3384 S. Baker Vol #: 176
EMC 3385 D. Riggle Vol #: 176
EMC 3386 D. Andreychuk Vol #: 176
EMC 3387 D. Mejia Vol #: 176
EMC 3388 K. Kajer Vol #: 176
EMC 3389 G. Antares Vol #: 176
EMC 3390 N. Bartetzko Vol #: 176
EMC 3391 J. Held Vol #: 176
EMC 3392 C. Post Vol #: 176
EMC 3393 M. Aspinwall Vol #: 176
EMC 3394 M. Aspinwall Vol #: 176
EMC 3395 D. Troxell Vol #: 176
EMC 3396 J. Terlizzi Vol #: 176
EMC 3397 T. Scroggins Vol #: 176
EMC 3398 C. Conti Vol #: 176
EMC 3399 H. Coleman Vol #: 176
EMC 3400 M. Wrobleski Vol #: 176
EMC 3401 W. Hahn Vol #: 176
EMC 3402 L. Havran Vol #: 176
EMC 3403 M. Lenker Vol #: 176
EMC 3404 M. Lenker Vol #: 176
EMC 3405 C. Haditsch Vol #: 176
EMC 3406 K. Sullivan Vol #: 176
EMC 3407 M. Lenker Vol #: 176
EMC 3408 M. Lenker Vol #: 176
EMC 3409 R. Lindsay Vol #: 176
EMC 3410 R. Mulligan Vol #: 176
EMC 3411 R. Lindsay Vol #: 176
EMC 3412 J. Knuttila Vol #: 176
EMC 3413 H. McLeod Vol #: 176
EMC 3414 T. Seely Vol #: 176
EMC 3415 L. Stoecker Vol #: 176
EMC 3416 E. Carlson Vol #: 176
EMC 3417 L. Grace Vol #: 176
EMC 3418 P. Clem Vol #: 176
EMC 3419 N. Stewart Vol #: 176
EMC 3420 K. Caprino-Burg Vol #: 176
EMC 3421 C. Schudda Vol #: 176
EMC 3422 R. Reitan Vol #: 176
EMC 3423 B. Dragoo Vol #: 176
EMC 3424 G. Knouse Vol #: 176
EMC 3425 M. Orecchio Vol #: 176
EMC 3426 B. Cole Vol #: 176
2006D-0275 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2006E-0250 Patent Extension Application for SOLTAMOX (tamoxifen citrate for oral administration), U.S. Patent No. 6,127,425
LET 2 HFD-005 to U.S. Patent and Trademark Office Vol #: 1
2006M-0293 P050044 - Vitagel Surgical Hemostat - Approved 6/16/06
AAV 1 Orthovita, Inc. Vol #: 1
2006M-0294 P050017 - Zilver Vascular Stent - Approved 6/26/06
AAV 1 Cook, Inc. Vol #: 1
2006M-0295 P050014 - Fuji Computed Radiography Mammography Suite (FCRMS) - Approved 7/10/06
AAV 1 Fujifilm Medical Systems, USA, Inc. Vol #: 1
2006N-0276 Medical Devices; Immunology and Microbiology Devices; Classification of Fecal Calprotectin Immunological Test Systems
BKG 1 Background Vol #: 1
NFR 1 FDA Vol #: 1
2006P-0052 Determine whether Sustiva (efavirenz) Tablets, 300 mg (NDA 21-360), has been voluntarily withdrawn for safety or effectiveness reasons
LET 1 FDA/CDER to Lachman Consultant Services, Inc. Vol #: 1
2006P-0205 Require Vitamin D be added to cereal-grain products
C 2 University of Minnesota Vol #: 2

Page created on August 18, 2006 kk

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