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| Dockets Entered
On September 18, 2007
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| Docket #
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| Title
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| 1996V-0474
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| Variance Application for High Pressure Mercury Vapor Lamps
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| 1997N-0497
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| Allogeneic Peripheral and Placental/ Umbilical Cord Blood
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2004E-0300
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
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| 2004E-0301
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
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| 2004E-0302
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| Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
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| 2004E-0303
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
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| 2004E-0304
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
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| 2004E-0306
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
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| 2004E-0426
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
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| 2006E-0206
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| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
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| 2006E-0236
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| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
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| 2006E-0252
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| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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| 2006E-0355
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| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
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| 2006E-0356
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| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006P-0487
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| Health Claim Petition: Isomaltulose and Dental Caries
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| 2007N-0186
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| 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
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| 2007V-0349
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| Laser Light Show
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| 2007V-0350
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| Laser Light Show Display
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| 1996N-0417
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| CGMP in Mfg. Packing or Holding Dietary Supplements
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| C 282
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| Arthur J. Hollowell
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| Vol #:
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| 54
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| 1996V-0474
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| Variance Application for High Pressure Mercury Vapor Lamps
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| EXP 2
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| GE Consumer abnd Industrial
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| Vol #:
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| 1
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| 1997N-0497
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| Allogeneic Peripheral and Placental/ Umbilical Cord Blood
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| SUP 9
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| National Marrow Donor
Program (NMDP)
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| Vol #:
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| 7
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 20771
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| NOW Foods
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| Vol #:
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| 181
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| LET 20772
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| NOW Foods
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| Vol #:
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| 181
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| LET 20773
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| NOW Foods
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| Vol #:
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| 181
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| | | | | | | |
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| LET 20774
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| NOW Foods
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| Vol #:
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| 181
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| LET 20775
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| NOW Foods
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| Vol #:
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| 181
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| LET 20776
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| NOW Foods
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| Vol #:
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| 181
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| LET 20777
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| NOW Foods
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| Vol #:
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| 181
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| LET 20778
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| NOW Foods
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| Vol #:
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| 181
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| LET 20779
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| NOW Foods
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| Vol #:
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| 181
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| LET 20780
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| NOW Foods
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| Vol #:
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| 181
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| LET 20781
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| NOW Foods
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| Vol #:
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| 181
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| LET 20782
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| NOW Foods
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| Vol #:
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| 181
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| LET 20783
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| NOW Foods
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| Vol #:
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| 181
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| LET 20784
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| NOW Foods
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| Vol #:
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| 181
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| LET 20785
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| NOW Foods
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| Vol #:
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| 181
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| LET 20786
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| NOW Foods
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| Vol #:
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| 181
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| LET 20787
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| NOW Foods
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| Vol #:
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| 181
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| LET 20788
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| NOW Foods
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| Vol #:
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| 181
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| LET 20789
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| NOW Foods
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| Vol #:
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| 181
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| LET 20790
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| NOW Foods
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| Vol #:
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| 181
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| LET 20791
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| NOW Foods
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| Vol #:
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| 181
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| LET 20792
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| NOW Foods
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| Vol #:
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| 181
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| LET 20793
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| NOW Foods
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| Vol #:
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| 181
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| LET 20794
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| NOW Foods
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| Vol #:
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| 181
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| LET 20795
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| NOW Foods
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| Vol #:
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| 181
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| LET 20796
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| NOW Foods
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| Vol #:
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| 181
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| LET 20797
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| NOW Foods
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| Vol #:
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| 181
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| LET 20798
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| NOW Foods
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| Vol #:
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| 181
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| LET 20799
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| NOW Foods
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| Vol #:
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| 181
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| LET 20800
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| NOW Foods
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| Vol #:
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| 181
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| LET 20801
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| NOW Foods
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| Vol #:
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| 181
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| LET 20802
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| NOW Foods
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| Vol #:
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| 181
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| LET 20803
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| NOW Foods
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| Vol #:
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| 181
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| LET 20804
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| NOW Foods
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| Vol #:
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| 181
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| LET 20805
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| Source Naturals
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| Vol #:
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| 181
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| LET 20806
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| NOW Foods
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| Vol #:
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| 181
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| LET 20807
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| NOW Foods
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| Vol #:
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| 181
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| LET 20808
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| NOW Foods
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| Vol #:
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| 181
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| LET 20809
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| Doctors' Research, Inc.
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| Vol #:
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| 181
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| LET 20810
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| Doctors' Research, Inc.
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| Vol #:
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| 181
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| | | | | | | | |
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| LET 20811
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| Doctors' Research, Inc.
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| Vol #:
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| 181
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| LET 20812
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| Doctors' Research, Inc.
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| Vol #:
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| 181
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| LET 20813
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| Doctors' Research, Inc.
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| Vol #:
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| 181
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| LET 20814
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| DMD Pharmaceuticals
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| Vol #:
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| 181
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| LET 20815
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| Enzmatic
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| Vol #:
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| 181
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| LET 20816
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| Enzmatic
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| Vol #:
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| 181
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| LET 20817
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| Enzmatic
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| Vol #:
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| 181
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| LET 20818
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| Enzmatic
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| Vol #:
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| 181
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| LET 20819
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| Enzmatic
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| Vol #:
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| 181
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| LET 20820
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| Enzmatic
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| Vol #:
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| 181
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|
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| LET 20821
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| Enzmatic
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| Vol #:
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| 181
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|
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| LET 20822
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| Enzmatic
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| Vol #:
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| 181
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|
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| LET 20823
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| Enzmatic
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| Vol #:
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| 181
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|
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| LET 20824
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| Enzmatic
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| Vol #:
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| 181
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| LET 20825
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| Enzmatic
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| Vol #:
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| 181
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|
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| LET 20826
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| Enzmatic
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| Vol #:
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| 181
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| LET 20827
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| Enzmatic
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| Vol #:
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| 181
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| LET 20828
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| Enzmatic
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| Vol #:
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| 181
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| LET 20829
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| Enzmatic
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| Vol #:
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| 181
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| LET 20830
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| NBTY
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| Vol #:
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| 181
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| LET 20831
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| NBTY
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| Vol #:
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| 181
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|
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| LET 20832
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| NBTY
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| Vol #:
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| 181
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|
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| LET 20833
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| NBTY
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| Vol #:
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| 181
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|
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| LET 20834
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| NBTY
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| Vol #:
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| 181
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| LET 20835
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| NBTY
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| Vol #:
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| 181
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|
|
| 2004E-0300
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,800,509
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
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| 2004E-0301
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,891,190
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004E-0302
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| Patent Extenstion for S8 Over-the Wire System ( Driver Stent Delivery System), U.S. Patent No. 6,309,402
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|
|
| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
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| 2004E-0303
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,879,382
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|
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
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| 2004E-0304
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,292,331
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|
| | | | | | | | |
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| LET 8
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
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| 2004E-0306
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 5,836,965
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|
|
| LET 8
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
|
| 2004E-0426
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| Patent Extension for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,344,053
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|
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
|
| 2006E-0206
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| Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
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|
|
| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
|
| 2006E-0236
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| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
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|
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
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| 2006E-0252
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| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
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|
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
|
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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|
|
| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
|
| 2006E-0355
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| Patent Extension Application for AMITIZA (lubiprostone), U.S. Patent No. 5,284,858
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|
|
| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
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| 2006E-0356
|
| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
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|
|
| LET 5
|
| FDA/CDER to the U.S. Patent and Trademark Office
|
| Vol #:
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| 1
|
|
|
| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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|
| C 2423
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| G Walker
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| Vol #:
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| 26
|
|
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| C 2424
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| D Sheldon
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| Vol #:
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| 26
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|
|
| C 2425
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| T Forbes
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| Vol #:
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| 26
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|
|
| C 2426
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| P Hotchkiss
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| Vol #:
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| 26
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|
|
| C 2427
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| E Pieri
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| Vol #:
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| 26
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|
|
| C 2428
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| I Lowndes
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| Vol #:
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| 26
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|
|
| C 2429
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| R Howard
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| Vol #:
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| 26
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|
|
| C 2430
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| L Hans
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| Vol #:
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| 26
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|
|
| C 2431
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| B Mahaney
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| Vol #:
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| 26
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|
|
| C 2432
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| A Hopkins
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| Vol #:
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| 26
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|
|
| C 2433
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| S Leone
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| Vol #:
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| 26
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|
|
| C 2434
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| D Fiedler
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| Vol #:
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| 26
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|
|
| C 2435
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| M Bumbulis
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| Vol #:
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| 26
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|
| | | | | | | |
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| C 2436
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| M Sager
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| Vol #:
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| 26
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|
|
| C 2437
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| M Borcherding
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| Vol #:
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| 26
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|
|
| C 2438
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| M Hulka
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| Vol #:
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| 26
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|
|
| C 2439
|
| W Dadisman
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| Vol #:
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| 26
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|
|
| C 2440
|
| W Moore
|
| Vol #:
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| 26
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|
|
| C 2441
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| A Pyle
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| Vol #:
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| 26
|
|
|
| C 2442
|
| M Kritner
|
| Vol #:
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| 27
|
|
|
| C 2443
|
| J LePage
|
| Vol #:
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| 27
|
|
|
| C 2444
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| K Allen
|
| Vol #:
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| 27
|
|
|
| C 2445
|
| E Sparks
|
| Vol #:
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| 27
|
|
|
| C 2446
|
| A Levy
|
| Vol #:
|
| 27
|
|
|
| C 2447
|
| M Virden
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| Vol #:
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| 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
|
|
|