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| Dockets Entered
On October 27, 2004
Table of Contents
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| Docket #
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| Title
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| 1998D-0785
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| Medical imaging drugs and biologics
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2002P-0029
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| Mylan estradiol transdermal system as generic substitute
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2004M-0467
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| P030032/S001 - Hylaform Plus, Approved 10/13/04
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| 2004M-0471
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| Syncardia Systems, Inc., Premarket Approval for Syncardia Temporary CardioWest Total Artificial Heart (TAH-t
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| 2004P-0206
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| No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2004P-0472
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| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
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| 1998D-0785
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| Medical imaging drugs and biologics
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| C
32
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| Council on Radionuclides and Radiopharmaceuticals (CORAR) and Medical Imaging Contrast Agent A
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| 6
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| C
279
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| Goldsboro Milling Company
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| Vol #:
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| 99
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| C
280
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| American College of Poultry Veterinarians
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| Vol #:
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| 99
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| 2002P-0029
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| Mylan estradiol transdermal system as generic substitute
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| PDN
1
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| HFD-001 to Berlex Laboratories, Inc.
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| Vol #:
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| 1
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| C
33
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| Natural Resources Defense Council (NRDC)
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| 6
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| 2004M-0467
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| P030032/S001 - Hylaform Plus, Approved 10/13/04
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| AAV
1
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| Genzyme Biosurgery
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| 1
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| 2004M-0471
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| Syncardia Systems, Inc., Premarket Approval for Syncardia Temporary CardioWest Total Artificial Heart (TAH-t
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| AAV
1
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| Syncardia Systems, Inc.
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| Vol #:
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| 1
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| 2004P-0206
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| No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies
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| LET
2
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| HFD-005 to Bell, Boyd & Lloyd LLC
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| Vol #:
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| 1
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| 2004P-0349
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| Action on Products containing added Mercury
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| C
4
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| The Genetic Centers of America
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| Vol #:
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| 1
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| C
5
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| MedCon, Inc.
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| Vol #:
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| 1
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| C
6
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| Children HAving Advocates Against Mercury Poisoning (CHAMP)
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| Vol #:
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| 1
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| 2004P-0472
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| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
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| ACK
1
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| HFA-305 to Dr. Daniel Brookoff
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| Vol #:
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| 1
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