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| Dockets Entered
On May 24, 2004
Table of Contents
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| Docket #
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| Title
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2003D-0538
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| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment
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| 2004P-0243
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| Oxycodone and Acetaminophen tablet USP, 2.5 mg/400 mg. 5 mg/400 mg,7.5 mg/ 400 mg and 10 mg/400 mg
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 6829
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| Sarah Beck
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| Vol #:
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| 235
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| EMC 6830
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| B. Dyke
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| Vol #:
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| 235
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| EMC 6831
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| S. F. Parnes
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| Vol #:
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| 235
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| EMC 6832
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| J. Pence
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| Vol #:
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| 235
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| EMC 6833
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| V. Siauw
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| Vol #:
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| 235
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| EMC 6834
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| J. Baldwin
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| Vol #:
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| 235
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| EMC 6835
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| J. Oneil
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| Vol #:
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| 235
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| EMC 6836
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| C. J. Heilman
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| Vol #:
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| 235
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| EMC 6837
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| S. Langnas
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| Vol #:
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| 235
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| EMC 6838
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| E. Viernes
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| Vol #:
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| 235
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| EMC 6839
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| E. T. Kimball
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| Vol #:
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| 235
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| EMC 6840
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| L. D. Mabbott
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| Vol #:
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| 235
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| EMC 6841
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| Dorothy Flowers
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| Vol #:
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| 235
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| EMC 6842
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| R. Graves
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| Vol #:
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| 235
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| EMC 6843
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| E. M. Schneider, M.D.
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| Vol #:
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| 235
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| EMC 6844
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| B. Clark
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| Vol #:
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| 235
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| EMC 6845
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| M. L. Hicks
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| Vol #:
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| 235
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| EMC 6846
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| R. Martine
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| Vol #:
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| 235
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| EMC 6847
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| C. Wilson
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| Vol #:
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| 235
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| EMC 6848
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| M. Azawi
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| Vol #:
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| 235
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| EMC 6849
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| J. Kim
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| Vol #:
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| 235
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| EMC 6850
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| Cj Dupont
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| Vol #:
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| 235
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| EMC 6851
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| D. Wwelch
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| Vol #:
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| 235
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| EMC 6852
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| CJ Dupont
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| Vol #:
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| 235
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| EMC 6853
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| Thalia Johnson
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| Vol #:
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| 235
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| EMC 6854
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| R. Wickberg
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| Vol #:
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| 235
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| EMC 6855
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| S. Steffy
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| Vol #:
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| 235
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| EMC 6856
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| L. Walker
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| Vol #:
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| 235
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| EMC 6857
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| J. Suitt
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| Vol #:
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| 235
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| EMC 6858
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| W. Root
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| Vol #:
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| 235
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| EMC 6859
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| Y. Chen
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| Vol #:
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| 235
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| EMC 6860
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| Y. Chen
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| Vol #:
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| 235
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| EMC 6861
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| D. Hind
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| Vol #:
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| 235
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| EMC 6862
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| D. Burroughs
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| Vol #:
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| 235
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| EMC 6863
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| K. Burkhardt
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| Vol #:
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| 235
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| EMC 6864
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| R. Mesek
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| Vol #:
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| 235
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| EMC 6865
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| R. Mesek
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| Vol #:
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| 235
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| EMC 6866
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| M. J. Pane
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| Vol #:
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| 235
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| EMC 6867
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| G. Rainley
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| Vol #:
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| 235
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| EMC 6868
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| D. Melander
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| Vol #:
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| 235
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| EMC 6869
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| J. Espe
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| Vol #:
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| 235
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| EMC 6870
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| E. Frampton
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| Vol #:
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| 235
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| EMC 6871
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| K. Meagher
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| Vol #:
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| 235
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| EMC 6872
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| Erlene Jackson
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| Vol #:
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| 235
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| EMC 6873
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| G. Pollak
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| Vol #:
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| 235
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| EMC 6874
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| Sara Nay Feltner
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| Vol #:
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| 235
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| EMC 6875
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| C. Westervelt
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| Vol #:
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| 235
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| EMC 6876
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| S. Pitcher
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| Vol #:
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| 235
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| EMC 6877
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| K. Simmons
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| Vol #:
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| 235
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| EMC 6878
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| D. J. Volatile
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| Vol #:
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| 234
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| EMC 6879
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| V. Vantuil
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| Vol #:
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| 235
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| EMC 6880
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| J. Ferraro
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| Vol #:
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| 235
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| EMC 6881
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| Kathleen Cutler
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| Vol #:
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| 235
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| EMC 6882
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| M. K. Marin
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| Vol #:
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| 235
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| EMC 6883
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| Y. Bolitho
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| Vol #:
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| 235
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| EMC 6884
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| E. Schmitz
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| Vol #:
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| 235
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| EMC 6885
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| P. Clark
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| Vol #:
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| 235
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| EMC 6886
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| E. Snyder
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| Vol #:
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| 235
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| EMC 6887
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| J. Bello
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| Vol #:
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| 235
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| EMC 6888
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| E. Snyder
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| Vol #:
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| 235
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| EMC 6889
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| L. Delap
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| Vol #:
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| 235
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| EMC 6890
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| J. E. Fisher
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| Vol #:
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| 235
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| EMC 6891
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| S. Greenwald
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| Vol #:
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| 235
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| EMC 6892
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| Tammy Leech
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| Vol #:
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| 235
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| EMC 6893
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| V. McCarter
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| Vol #:
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| 235
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| EMC 6894
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| M. Carlisle
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| Vol #:
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| 235
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| EMC 6895
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| M. Steinberg
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| Vol #:
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| 235
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| EMC 6896
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| M. Summer
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| Vol #:
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| 235
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| EMC 6897
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| J. Newman
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| Vol #:
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| 235
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| EMC 6898
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| A. Stueve
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| Vol #:
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| 235
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| EMC 6899
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| M. R. Roberts
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| Vol #:
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| 234
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| EMC 6900
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| D. Hadler
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| Vol #:
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| 235
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| 2003D-0538
|
| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification Submissions 510(k): Effect on FDA Review Clock and Performance Assessment
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0243
|
| Oxycodone and Acetaminophen tablet USP, 2.5 mg/400 mg. 5 mg/400 mg,7.5 mg/ 400 mg and 10 mg/400 mg
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| |
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| ACK
1
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| Lachman Consultant Services, Inc.
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| Vol #:
|
| 1
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| CP
1
Attachment A,
B,
C
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| Lachman Consultant Services, Inc.
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| Vol #:
|
| 1
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