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Dockets Management

Dockets Entered On September 18, 2007
Docket # Title
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
1996V-0474 Variance Application for High Pressure Mercury Vapor Lamps
1997N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2004E-0300 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
2004E-0301 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
2004E-0302 Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
2004E-0303 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
2004E-0304 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
2004E-0306 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
2004E-0426 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
2006E-0206 Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
2006E-0236 Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
2006E-0252 Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
2006E-0261 Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
2006E-0355 Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
2006E-0356 Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0487 Health Claim Petition: Isomaltulose and Dental Caries
2007D-0083 Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
2007N-0186 Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
2007V-0349 Laser Light Show
2007V-0350 Laser Light Show Display
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
C 282 Arthur J. Hollowell Vol #: 54
1996V-0474 Variance Application for High Pressure Mercury Vapor Lamps
EXP 2 GE Consumer abnd Industrial Vol #: 1
1997N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood
SUP 9 National Marrow Donor Program (NMDP) Vol #: 7
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 20771 NOW Foods Vol #: 181
LET 20772 NOW Foods Vol #: 181
LET 20773 NOW Foods Vol #: 181
LET 20774 NOW Foods Vol #: 181
LET 20775 NOW Foods Vol #: 181
LET 20776 NOW Foods Vol #: 181
LET 20777 NOW Foods Vol #: 181
LET 20778 NOW Foods Vol #: 181
LET 20779 NOW Foods Vol #: 181
LET 20780 NOW Foods Vol #: 181
LET 20781 NOW Foods Vol #: 181
LET 20782 NOW Foods Vol #: 181
LET 20783 NOW Foods Vol #: 181
LET 20784 NOW Foods Vol #: 181
LET 20785 NOW Foods Vol #: 181
LET 20786 NOW Foods Vol #: 181
LET 20787 NOW Foods Vol #: 181
LET 20788 NOW Foods Vol #: 181
LET 20789 NOW Foods Vol #: 181
LET 20790 NOW Foods Vol #: 181
LET 20791 NOW Foods Vol #: 181
LET 20792 NOW Foods Vol #: 181
LET 20793 NOW Foods Vol #: 181
LET 20794 NOW Foods Vol #: 181
LET 20795 NOW Foods Vol #: 181
LET 20796 NOW Foods Vol #: 181
LET 20797 NOW Foods Vol #: 181
LET 20798 NOW Foods Vol #: 181
LET 20799 NOW Foods Vol #: 181
LET 20800 NOW Foods Vol #: 181
LET 20801 NOW Foods Vol #: 181
LET 20802 NOW Foods Vol #: 181
LET 20803 NOW Foods Vol #: 181
LET 20804 NOW Foods Vol #: 181
LET 20805 Source Naturals Vol #: 181
LET 20806 NOW Foods Vol #: 181
LET 20807 NOW Foods Vol #: 181
LET 20808 NOW Foods Vol #: 181
LET 20809 Doctors' Research, Inc. Vol #: 181
LET 20810 Doctors' Research, Inc. Vol #: 181
LET 20811 Doctors' Research, Inc. Vol #: 181
LET 20812 Doctors' Research, Inc. Vol #: 181
LET 20813 Doctors' Research, Inc. Vol #: 181
LET 20814 DMD Pharmaceuticals Vol #: 181
LET 20815 Enzmatic Vol #: 181
LET 20816 Enzmatic Vol #: 181
LET 20817 Enzmatic Vol #: 181
LET 20818 Enzmatic Vol #: 181
LET 20819 Enzmatic Vol #: 181
LET 20820 Enzmatic Vol #: 181
LET 20821 Enzmatic Vol #: 181
LET 20822 Enzmatic Vol #: 181
LET 20823 Enzmatic Vol #: 181
LET 20824 Enzmatic Vol #: 181
LET 20825 Enzmatic Vol #: 181
LET 20826 Enzmatic Vol #: 181
LET 20827 Enzmatic Vol #: 181
LET 20828 Enzmatic Vol #: 181
LET 20829 Enzmatic Vol #: 181
LET 20830 NBTY Vol #: 181
LET 20831 NBTY Vol #: 181
LET 20832 NBTY Vol #: 181
LET 20833 NBTY Vol #: 181
LET 20834 NBTY Vol #: 181
LET 20835 NBTY Vol #: 181
2004E-0300 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2004E-0301 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2004E-0302 Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2004E-0303 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2004E-0304 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
LET 8 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2004E-0306 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
LET 8 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2004E-0426 Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0206 Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
LET 6 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0236 Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0252 Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0261 Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0355 Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0356 Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
LET 5 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 2423 G Walker Vol #: 26
C 2424 D Sheldon Vol #: 26
C 2425 T Forbes Vol #: 26
C 2426 P Hotchkiss Vol #: 26
C 2427 E Pieri Vol #: 26
C 2428 I Lowndes Vol #: 26
C 2429 R Howard Vol #: 26
C 2430 L Hans Vol #: 26
C 2431 B Mahaney Vol #: 26
C 2432 A Hopkins Vol #: 26
C 2433 S Leone Vol #: 26
C 2434 D Fiedler Vol #: 26
C 2435 M Bumbulis Vol #: 26
C 2436 M Sager Vol #: 26
C 2437 M Borcherding Vol #: 26
C 2438 M Hulka Vol #: 26
C 2439 W Dadisman Vol #: 26
C 2440 W Moore Vol #: 26
C 2441 A Pyle Vol #: 26
C 2442 M Kritner Vol #: 27
C 2443 J LePage Vol #: 27
C 2444 K Allen Vol #: 27
C 2445 E Sparks Vol #: 27
C 2446 A Levy Vol #: 27
C 2447 M Virden Vol #: 27
C 2448 H Hrivnak Vol #: 27
C 2449 V Carter Vol #: 27
C 2450 B Jolly Vol #: 27
C 2451 L Cornier Vol #: 27
C 2452 R Nolan Vol #: 27
C 2453 D Schwanbeck Vol #: 27
C 2454 D Stutzman Vol #: 27
C 2455 G Ailshie Vol #: 27
C 2456 L Sweeney Vol #: 27
C 2457 N Chaples Vol #: 27
C 2458 T Jacks Vol #: 27
C 2459 G Schroeder Vol #: 27
C 2460 L Kirschner Vol #: 27
C 2461 M Yunginger Vol #: 27
C 2462 B Lindenmuith Vol #: 27
C 2463 R Bennett Vol #: 27
C 2464 G Jara Vol #: 27
C 2465 A Heaney Vol #: 27
C 2466 A Stec Vol #: 27
C 2467 W Kelley Vol #: 27
C 2468 M Heldt Vol #: 27
C 2469 B Forest Vol #: 27
C 2470 E Taylor Vol #: 27
C 2471 M Saunders Vol #: 27
C 2472 G Prendergast Vol #: 27
C 2473 E Raasch Vol #: 27
C 2474 no signature Vol #: 27
C 2475 A Hudson Vol #: 27
C 2476 T Espinola Vol #: 27
C 2477 R Jefferys Vol #: 27
C 2478 R Morgan Vol #: 27
C 2479 A Preston Vol #: 27
C 2480 J Magnusson Vol #: 27
C 2481 C Pratt Vol #: 27
C 2482 C Sutton Vol #: 27
C 2483 A Gerndt Vol #: 27
C 2484 L Mora Vol #: 27
C 2485 L Mazepink Vol #: 27
C 2486 J Kendall Vol #: 27
C 2487 L Kendall Vol #: 27
C 2488 L Morphis Vol #: 27
C 2489 M Jacobson Vol #: 27
C 2490 J Evans Vol #: 27
C 2491 D Young Vol #: 27
C 2492 Asthma and Allergy Foundation of America Vol #: 27
C 2493 K Lorance Vol #: 27
C 2494 J Moler Vol #: 27
C 2495 G Fisher Vol #: 27
C 2496 M Sexson Vol #: 27
C 2497 B Simonowitz Vol #: 27
C 2498 L Mazepink Vol #: 27
C 2499 V Bouckaert Vol #: 27
C 2500 R Terry Vol #: 27
C 2501 M Dopperschmidt Vol #: 27
C 2502 S Schwesiq Vol #: 27
C 2503 E Bigley Vol #: 27
C 2504 T Thacker Vol #: 24
C 2505 S Kanovsky Vol #: 27
C 2506 N Bale Vol #: 27
C 2507 S Miller Vol #: 27
C 2508 S Rudolph Vol #: 27
C 2509 K Lane Vol #: 27
C 2510 P Mason Vol #: 27
C 2511 L McJunkins Vol #: 27
C 2512 R Voss Vol #: 27
C 2513 N Blackmon Vol #: 27
C 2514 D Hantsman Vol #: 27
C 2515 J Wood Vol #: 27
C 2516 W Fish Vol #: 27
C 2517 W Tuffiash Vol #: 27
C 2518 D Huntley Vol #: 27
C 2519 J Davis Vol #: 27
C 2520 L Mitchell Vol #: 27
C 2521 E Lanwill Vol #: 27
C 2522 A LeGasse Vol #: 27
C 2523 N Brown Vol #: 27
C 2524 G LaRousse Vol #: 27
C 2525 B Melnin Vol #: 27
C 2526 F DiOim Vol #: 27
C 2527 L Sey Vol #: 27
C 2528 P Wolfe Vol #: 27
C 2529 G Blinn Vol #: 27
C 2530 H Hackney Vol #: 27
C 2531 A Gillespie Vol #: 27
C 2532 H Wallis Vol #: 27
C 2533 J Robbin Vol #: 27
C 2534 K Aubart Vol #: 27
C 2535 V Pytlik Vol #: 27
C 2536 R Humphreys Vol #: 27
C 2537 D Thompson Vol #: 27
C 2538 S Holderle Vol #: 27
C 2539 L Gohil Vol #: 27
C 2540 I Roberts Vol #: 27
C 2541 F Rapier Vol #: 27
C 2542 H Albers Vol #: 27
C 2543 G Scores Vol #: 27
C 2544 F Parkers Vol #: 27
C 2545 K Bunch Vol #: 27
C 2546 R Kerr Vol #: 27
C 2547 M Mitchell Vol #: 27
C 2548 W Bledsoe Vol #: 27
C 2549 F Smarro Vol #: 27
C 2550 J Cyphert Vol #: 27
C 2551 H Rosengren Vol #: 27
C 2552 V Jane Hartmeier Vol #: 27
C 2553 G Gilliam Vol #: 27
C 2554 R Foote Vol #: 27
C 2555 D Konth Vol #: 27
C 2556 L Pieke Vol #: 27
C 2557 C O'Neil Vol #: 27
2006P-0487 Health Claim Petition: Isomaltulose and Dental Caries
EREG 1 B. Sachau Vol #: 1
2007D-0083 Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
C 6 AdvaMed Vol #: 1
2007N-0186 Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
EREG 1 B. Sachau Vol #: 1
2007V-0349 Laser Light Show
ACK 1 FDA/ DDM/ to Amanda Kushner Vol #: 1
VAR 1 Amanda Kushner Vol #: 1
2007V-0350 Laser Light Show Display
ACK 1 FDA/ DDM/ to Vestar Temple Market Place Vol #: 1
VAR 1 Vestar Temple Market Place Vol #: 1

Page created on September 18, 2007 ue

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