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| Dockets Entered
On May 17, 2007
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| 2002E-0156
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| Galileo Intravascular Radiotherapy System
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004E-0319
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| Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| 2005E-0251
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| 2006D-0526
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| International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics
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| 2006E-0332
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
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| 2006E-0333
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
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| 2006E-0495
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| Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
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| 2006E-0516
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| Patent Extension Application for SPRYCEL (dasatinib), U.S. Patent No. 6,596,746
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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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| 2006P-0462
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| Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe
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| 2006P-0511
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| Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| 2007E-0002
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| Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
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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-0148
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| Patent Extension Application for TYZEKA (telbivudine), U.S. Patent No. 6,569,837
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007P-0044
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| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
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| 1976N-0052N
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| OTC Nasal Decongestants
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| C 252
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| Yale University School of Medicine
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| Vol #:
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| 86
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| C 129
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| Yale University School of Medicine
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| Vol #:
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| 98
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| 2002E-0156
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| Galileo Intravascular Radiotherapy System
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| LET 4
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| FDA/CDER to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 1023
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| Form Letter count
1714
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| 0
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| C 1024
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| Form Letter count
1750
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| Vol #:
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| 0
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| EMC 404
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| D. Atwood
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| Vol #:
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| 5
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| EMC 405
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| P. Polland
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| Vol #:
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| 5
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| EMC 406
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| J. Thompson
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| Vol #:
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| 5
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| EMC 407
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| C. Osborn
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| Vol #:
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| 5
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| EMC 408
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| L. French
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| Vol #:
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| 5
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| EMC 409
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| C. Fair
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| Vol #:
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| 5
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| EMC 410
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| V. Mcaleter
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| Vol #:
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| 5
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| EMC 411
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| R. Trott
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| Vol #:
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| 5
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| EMC 412
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| E. Jones
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| Vol #:
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| 5
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| EMC 413
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| J. Humiston
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| Vol #:
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| 5
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| EMC 414
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| E. Perchonock
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| Vol #:
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| 5
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| EMC 415
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| C. Maris
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| Vol #:
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| 5
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| EMC 416
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| H. Goulding
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| Vol #:
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| 5
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| EMC 417
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| L. Cantor
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| Vol #:
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| 5
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| EMC 418
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| S. Beattie
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| Vol #:
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| 5
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| EMC 419
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| A. Hayes
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| Vol #:
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| 5
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| EMC 420
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| A. Meisel
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| Vol #:
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| 5
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| EMC 421
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| M. Neria
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| Vol #:
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| 5
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| EMC 422
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| D. Nichols
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| Vol #:
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| 5
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| EMC 423
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| S. Glazier
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| Vol #:
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| 5
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| EMC 424
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| M. Allen
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| Vol #:
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| 5
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| EMC 425
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| R. Aster
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| Vol #:
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| 5
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| EMC 426
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| J. Berry
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| Vol #:
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| 5
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| EMC 427
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| P. Belcastro
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| Vol #:
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| 5
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| EMC 428
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| G. Ruiz
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| Vol #:
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| 5
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| 2004E-0319
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| Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
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| LET 4
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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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| 2004P-0448
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| DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
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| SUP 4
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| Hill Dermaceuticals, Inc.
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| Vol #:
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| 1
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| 2005E-0251
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| Patent Extension Application for Mycamine (micafungin sodium)(NDA 21-506), U.S. Patent No. 5,376,634
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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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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| C 30
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| J. Reese
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| Vol #:
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| 1
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| | | | | | | | |
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| C 17
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| St. Jude Medical (SJM)
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| Vol #:
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| 9
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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| EC 4
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| Just a retired radio general manager
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| Vol #:
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| 1
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| EC 5
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| Ms. Susan Longtin
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| Vol #:
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| 1
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| 2006D-0526
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| International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics
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| EC 1
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| Eli Lilly and Company
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| Vol #:
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| 1
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| EC 2
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC 3
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| Bio
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| Vol #:
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| 1
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| EC 4
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| Sanofi-aventis
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| Vol #:
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| 1
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| 2006E-0332
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,061,703
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|
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| LET 4
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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-0333
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| Patent Extension Application for NAMENDA (memantine hydrochloride), U.S. Patent No. 5,614,560
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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-0495
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| Patent Extension Application for Model KDR401 and KRD403 Pacemaker, U.S. Patent No. 4,958,632
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| LET 4
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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-0516
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| Patent Extension Application for SPRYCEL (dasatinib), U.S. Patent No. 6,596,746
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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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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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| C 3
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| Mylan Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| 2006P-0462
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| Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe
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| LET 1
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| FDA/CDER to Robert W. Pollock
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| Vol #:
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| 1
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| 2006P-0511
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| Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
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| C 2
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| Mallinckrodt
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| Vol #:
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| 1
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| 2007D-0101
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| Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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| M 1
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| FDA/OP
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| Vol #:
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| 1
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| 2007E-0002
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| Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
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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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| 2007E-0010
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| Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
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| LET 4
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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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| 2007E-0148
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| Patent Extension Application for TYZEKA (telbivudine), U.S. Patent No. 6,569,837
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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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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 199
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| Mazzarella, Charlie
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| Vol #:
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| 7
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| EAPE 200
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| Zwanziger, Lee
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| Vol #:
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| 7
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| EAPE 201
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| cranston, joseph
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| Vol #:
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| 7
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| EAPE 202
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| Governale, Laura
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| Vol #:
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| 7
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| EAPE 203
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| Goodrum, Jennifer
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| Vol #:
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| 7
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| EAPE 204
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| King, L.D.
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| Vol #:
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| 7
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| EAPE 205
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| Williamson, Brian
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| Vol #:
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| 7
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| EAPE 206
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| Flottman, Tom
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| Vol #:
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| 7
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| 2007P-0044
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| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
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| C 2
Attachments
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| Organon USA Inc
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| Vol #:
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| 7
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