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| Dockets Entered
On January 9, 2007
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| Docket #
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| Title
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 1997E-0013
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| Reteplase; Patent Term Extension Application No. 5,223,256
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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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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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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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-0234
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| Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
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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-0356
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| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
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| 2007E-0009
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| Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
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| 2007E-0010
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| Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
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| 2007E-0011
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| Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
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| 2007E-0012
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| Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 6,425,892
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| 2007E-0013
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| Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 5,697,896
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| 2007P-0008
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| Create a new policy to achieve expanded and accelerated development and production of pre-pandemic and pandemic vaccine
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT 773
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| Statistical Report - Month of December 2006
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| Vol #:
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| 55
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| 1997E-0013
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| Reteplase; Patent Term Extension Application No. 5,223,256
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| LET 3
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| U.S. Patent and Trademark Office tp FDA/CDER (HFD-7)
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| Vol #:
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| 1
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| EMC 3391
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| Number Not Used
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| Vol #:
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| 295
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| EMC 3392
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| Number Not Used
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| Vol #:
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| 295
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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 4
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
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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 4
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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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 4
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
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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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| LET 4
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
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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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| LET 6
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| U.S Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
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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 6
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
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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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| LET 4
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
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| 2006D-0344
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| Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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| C 14
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| Bristol-Myers Squibb Company
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| Vol #:
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| 1
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| C 422
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| R and M Sorensen
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| Vol #:
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| 33
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| C 423
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| M. Marsden
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| Vol #:
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| 33
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| C 424
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| T and V Young
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| Vol #:
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| 33
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| C 425
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| A. Bell
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| Vol #:
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| 33
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| C 426
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| B. Duffy
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| Vol #:
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| 33
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| C 427
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| J. Rovan
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| Vol #:
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| 33
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| C 428
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| B.Broyles
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| Vol #:
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| 33
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| C 429
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| K. Brune
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| Vol #:
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| 33
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| C 430
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| M. Birzten
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| Vol #:
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| 33
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| C 431
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| M. Henning
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| Vol #:
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| 33
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| C 432
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| D. Henry
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| Vol #:
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| 33
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| C 433
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| V. Stollus
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| Vol #:
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| 33
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| C 434
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| W. Baumgartner
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| Vol #:
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| 33
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| C 435
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| A. Grejdus
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| Vol #:
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| 33
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| C 436
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| M. Digna
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| Vol #:
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| 33
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| C 437
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| R. Bendel
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| Vol #:
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| 33
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| C 438
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| M. Kelly
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| Vol #:
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| 33
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| C 439
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| P. Birch
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| Vol #:
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| 33
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| C 440
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| L. Bate
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| Vol #:
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| 33
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| C 441
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| R. Reicher
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| Vol #:
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| 33
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| C 442
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| J. Gritt
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| Vol #:
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| 33
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| C 443
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| A. Janson
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| Vol #:
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| 33
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| C 444
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| A. Drager
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| Vol #:
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| 33
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| C 445
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| M. Anderson
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| Vol #:
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| 33
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| C 446
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| G. Crain
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| Vol #:
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| 33
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| C 447
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| P. McNellis
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| Vol #:
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| 33
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| C 448
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| M. Samuel
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| Vol #:
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| 33
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| C 449
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| M. Quinton
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| Vol #:
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| 33
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| C 450
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| D. Storms
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| Vol #:
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| 33
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| C 451
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| J. Krzebiot
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| Vol #:
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| 33
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| C 452
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| L. Wehling
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| Vol #:
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| 33
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| C 453
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| S and K Marshall
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| Vol #:
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| 33
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| C 454
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| W and B Bennes
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| Vol #:
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| 33
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| C 455
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| G. Hogan
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| Vol #:
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| 33
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| C 456
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| S. Knapp
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| Vol #:
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| 33
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| C 457
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| B. Fonferek
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| Vol #:
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| 33
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| C 458
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| P. Hayes
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| Vol #:
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| 33
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| C 459
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| P and R Roberts
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| Vol #:
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| 33
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| C 460
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| P. Kacsir
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| Vol #:
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| 33
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| C 461
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| A. Ruiz
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| Vol #:
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| 33
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| C 462
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| M. Ruiz
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| Vol #:
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| 33
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| C 463
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| R. McCafferty
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| Vol #:
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| 33
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| C 464
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| H. Anderson
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| Vol #:
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| 33
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| C 465
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| M. O'Connor
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| Vol #:
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| 33
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| C 466
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| E. Volkenburg
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| Vol #:
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| 33
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| C 467
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| R and E Fredette
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| Vol #:
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| 33
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| C 468
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| K. Webken
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| Vol #:
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| 33
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| C 469
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| D. Anderson
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| Vol #:
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| 33
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| C 470
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| H. Reuter
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| Vol #:
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| 33
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| C 471
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| S. Rog
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| Vol #:
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| 33
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| C 472
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| Mr and Mr R. Henneberry
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| Vol #:
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| 33
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| C 473
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| F and D Vandecttei
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| Vol #:
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| 33
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| C 474
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| B. Thiel
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| Vol #:
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| 33
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| C 475
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| R. Catello
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| Vol #:
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| 33
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| C 476
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| T. Tranel
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| Vol #:
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| 33
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| C 477
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| T. Hutt, MD
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| Vol #:
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| 33
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| C 478
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| M. Banyra
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| Vol #:
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| 33
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| C 479
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| V. Balchunch
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| Vol #:
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| 33
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| C 480
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| C. Swanson
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| Vol #:
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| 33
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| C 481
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| M. DeLand
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| Vol #:
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| 33
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| C 482
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| D. Wood
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| Vol #:
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| 33
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| C 483
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| M. Thelen
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| Vol #:
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| 33
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| C 484
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| M. Abbamonte
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| Vol #:
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| 33
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| C 485
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| T. Krupa
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| Vol #:
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| 33
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| C 486
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| A. Burke
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| Vol #:
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| 33
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| C 487
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| S. Moravsik
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| Vol #:
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| 33
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| C 488
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| P. Michelin
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| Vol #:
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| 33
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| C 489
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| C. Lindsay
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| Vol #:
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| 33
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| |
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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 4
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
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| |
|
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| 2006E-0234
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| Patent Extension Application for GEM 21S Growth-factor Enhanced Matrix, U.S. Patent No. 5,124,316
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| |
|
|
| LET 2
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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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| 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 3
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
|
| |
|
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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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| |
|
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| LET 3
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
|
| |
|
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| 2007E-0009
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| Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
|
| |
|
|
| APP 1
|
| Genzyme Corporation, Erasmus MC, Erasmus Universiteit, The Universteit Leiden
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| Vol #:
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| 1
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| |
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| LET 1
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| U.S. Patent & Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
|
| |
|
|
| 2007E-0010
|
| Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
|
| |
|
|
| APP 1
|
| Pfizer, Inc.
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| Vol #:
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| 1
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| |
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| LET 1
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
|
| |
|
|
| 2007E-0011
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| Patent Extension Application for Lantus (insulin glargine rDNA origin), U.S. Patent No. 5,101,013
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| |
|
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| APP 1
|
| Hoechst AG
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| Vol #:
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| 1
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| | | | | | | | |
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| |
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| LET 1
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
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| Vol #:
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| 1
|
| |
|
|
| 2007E-0012
|
| Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 6,425,892
|
| |
|
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| APP 1
|
| ALZA Corporation
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| Vol #:
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| 1
|
| |
|
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| LET 1
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| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
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| 1
|
| |
|
|
| 2007E-0013
|
| Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 5,697,896
|
| |
|
|
| APP 1
|
| ALZA Corporation
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| Vol #:
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| 1
|
| |
|
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| LET 1
|
| U.S. Patent & Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0008
|
| Create a new policy to achieve expanded and accelerated development and production of pre-pandemic and pandemic vaccine
|
| |
|
|
| CR 1
|
| FDA/DDM to Vaccine for All LLC
|
| Vol #:
|
| 1
|
|
|
