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| Dockets Entered
On October 21, 2004
Table of Contents
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| Docket #
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| Title
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002E-0340
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| Antagon, U.S. Patent No. 4,801,577
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| 2003D-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| 2003E-0406
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| Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804
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| 2003E-0411
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| Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262
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| 2003E-0416
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| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
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| 2003E-0419
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| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
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| 2003E-0448
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| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944
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| 2003E-0449
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| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468
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| 2003E-0458
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| Patent Extension, Velcade, bortezomib, #5,780,454
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2004E-0325
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| Patent Extension for Myfortic (mycophenolic acid) Delayed-Release Tablets, U.S. Patent No. 6,306,900
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| |
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| 2004N-0181
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| Critical Path Initiative
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| 2004P-0326
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| ANDA for Adenosine Injection, USP 3 mg/mL with 6 mL and 10 mL fill volumes
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| |
|
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| 2004P-0365
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| Refrain from approving ANDA for Agrylin (anagrelide hydrochloride) Capsules
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7458
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| Mr and MRs G Peterson
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| Vol #:
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| 319
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| C 7459
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| C. Sewarc
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| Vol #:
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| 319
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C
2038
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| Massachusetts Emergency Contraception Network
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| Vol #:
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| 295
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| EMC 10867
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| J. Kallander
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| Vol #:
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| 294
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| EMC 10868
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| S. Groot
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| Vol #:
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| 294
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| EMC 10869
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| A. Nagle
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| Vol #:
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| 294
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| EMC 10870
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| N. Burton
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| Vol #:
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| 294
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| EMC 10871
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| R. Johnson
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| Vol #:
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| 294
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| EMC 10872
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| R. Little
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| Vol #:
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| 294
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| EMC 10873
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| A. Hurley
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| Vol #:
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| 294
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| EMC 10874
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| R. Blank
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| Vol #:
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| 294
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| EMC 10875
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| A. Oberheim
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| Vol #:
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| 294
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| EMC 10876
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| K. Etzler
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| Vol #:
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| 294
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| EMC 10877
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| K. Franklin
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| Vol #:
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| 294
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| EMC 10878
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| J. Sterling
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| Vol #:
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| 294
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| EMC 10879
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| K. Etheredge
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| Vol #:
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| 294
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| EMC 10880
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| J. Armistead
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| Vol #:
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| 294
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| EMC 10881
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| K. Stine
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| Vol #:
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| 294
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| EMC 10882
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| R. Mizerak
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| Vol #:
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| 294
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| EMC 10883
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| A. Scherer
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| Vol #:
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| 294
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| EMC 10884
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| S. Celentano
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| Vol #:
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| 294
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| EMC 10885
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| D. Steele
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| Vol #:
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| 294
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| EMC 10886
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| J. Manders
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| Vol #:
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| 294
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| 2002E-0340
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| Antagon, U.S. Patent No. 4,801,577
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| LET
3
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| HFD-005 to U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2003D-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| |
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| LET 1
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| M. Hoef,MD,PhD,MBA
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| Vol #:
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| 1
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|
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| 2003E-0406
|
| Patent Term Restoration Application for Fabrazime, U.S. Patent No. 5,356,804
|
| |
|
|
| LET
5
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| HFD-005 to U.S. Patent & Trademark Office
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| Vol #:
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| 1
|
| |
|
|
| 2003E-0411
|
| Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262
|
| |
|
|
| LET
4
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| HFD-005 to U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2003E-0416
|
| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
|
| |
|
|
| LET
5
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| HFD-005 to U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
| |
|
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| 2003E-0419
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| Iprivask, Patent Term Extension Application; U.S. Patent No. 4,745,177
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| |
|
|
| LET
5
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| HFD-005 to U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2003E-0448
|
| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944
|
| |
|
|
| LET
4
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| HFD-005 to U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2003E-0449
|
| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468
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| |
|
|
| LET
3
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| HFD-005 to U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
| |
|
|
| 2003E-0458
|
| Patent Extension, Velcade, bortezomib, #5,780,454
|
| |
|
|
| LET
5
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| HFD-005 to U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
| |
|
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 436
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| G. Hajart
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| Vol #:
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| 9
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| EMC 437
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| R. Mizerak
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| Vol #:
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| 9
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| |
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| 2004E-0325
|
| Patent Extension for Myfortic (mycophenolic acid) Delayed-Release Tablets, U.S. Patent No. 6,306,900
|
| |
|
|
| LET
2
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| HFD-005 to U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
|
| | | | | | | | |
| |
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| |
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|
| C 143
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| E. Waggoner
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| Vol #:
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| 13
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| C 144
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| D. Cray
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| Vol #:
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| 13
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| 2004N-0181
|
| Critical Path Initiative
|
| |
|
|
| CR
1
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| L. Platt et al
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| Vol #:
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| 3
|
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|
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| 2004P-0326
|
| ANDA for Adenosine Injection, USP 3 mg/mL with 6 mL and 10 mL fill volumes
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| |
|
|
| LET
1
|
| Fijisawa Healthcare, Inc.
|
| Vol #:
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| 1
|
| |
|
|
| SUP
1
Attachment
A, B
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| Fujisawa Healthcare, Inc.
|
| Vol #:
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| 1
|
| |
|
|
| 2004P-0365
|
| Refrain from approving ANDA for Agrylin (anagrelide hydrochloride) Capsules
|
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|
| C
2
Attachment
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| Barr Laboratories, Inc.
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| Vol #:
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| 2
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