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| Dockets Entered
On June 9, 2004
Table of Contents
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| Docket
#
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| Title
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| 2004N-0086
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| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
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| 2004N-0221
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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| 2004P-0061
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| Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
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| 2004P-0131
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| ANDA Suitability for Tofin (tobramycin for Inhalation)
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrade
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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-0227
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| Adhere to the statutory limitations of section 505(j)(5)(B)(iv) of the Act in issuing final approvals to ANDA applicants
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| 2004V-0155
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| Valley Forge Composite Technologies Explosive Detection Systems
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 79
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 80
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 81
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 82
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 83
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 6987
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| K. Ailor
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| Vol #:
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| 237
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| EMC 6988
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| D. Bailey
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| Vol #:
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| 237
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| EMC 6989
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| P. Parsick
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| Vol #:
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| 237
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| EMC 6990
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| J. M.Jackman MD
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| Vol #:
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| 237
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| EMC 6991
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| T. Gumbiner
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| Vol #:
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| 237
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| EMC 6992
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| T. Hester
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| Vol #:
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| 237
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| EMC 6993
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| B. C. Balmer
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| Vol #:
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| 237
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| EMC 6994
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| G. Melnic
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| Vol #:
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| 237
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| EMC 6995
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| A. Talbert
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| Vol #:
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| 237
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| EMC 6996
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| K. Grant
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| Vol #:
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| 237
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| EMC 6997
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| J. Beers
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| Vol #:
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| 237
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| EMC 6998
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| A. Ryberg
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| Vol #:
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| 237
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| EMC 7036
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| J. Mackey
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| Vol #:
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| 237
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| EMC 7037
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| L. Frattarelli
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| Vol #:
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| 237
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| EMC 7038
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| M. Howell
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| Vol #:
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| 237
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| EMC 7039
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| G. Robertson
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| Vol #:
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| 237
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| EMC 7040
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| E. Maxwell
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| Vol #:
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| 237
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| EMC 7041
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| C. Heyde
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| Vol #:
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| 237
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| EMC 7042
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| R. J. W. Bantsimba
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| Vol #:
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| 237
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| EMC 7043
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| M. Abbott
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| Vol #:
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| 237
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| EMC 7044
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| R. Sanchez
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| Vol #:
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| 237
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| EMC 7045
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| W. Bain
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| Vol #:
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| 237
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| EMC 7046
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| C. L. Pattillo
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| Vol #:
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| 237
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| EMC 7047
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| P. M. Jordan
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| Vol #:
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| 237
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| EMC 7048
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| J. L. Frattarelli
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| Vol #:
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| 237
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| EMC 7049
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| M. Siemer
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| Vol #:
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| 237
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| EMC 7050
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| N. Lapitan
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| Vol #:
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| 237
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| C
339
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| Retail Industry Leaders Association
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| Vol #:
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| 29
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| C
340
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| Canadian Produce Marketing Association
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| Vol #:
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| 29
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| C
341
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| Taormina Sales Company Inc
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| Vol #:
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| 29
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| C
342
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| Government of Japan
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| Vol #:
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| 29
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| C
343
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| International Express Carriers Conference (IECC)
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| Vol #:
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| 29
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| C
344
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| British Airways
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| Vol #:
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| 29
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| C
345
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| J F Braun & Sons Inc
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| Vol #:
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| 29
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| C
346
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| Latvijas Pasts
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| Vol #:
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| 29
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| C
347
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| Family Winemakers of California
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| Vol #:
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| 29
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| EC 484
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| AIR-SEA FORWARDERS, INC.
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| Vol #:
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| 29
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| EC 485
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| Mr. Mikus Grinbergs
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| Vol #:
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| 29
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| EC 486
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| Ontario Pork
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| Vol #:
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| 29
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| EC 487
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| Dr. Boris Osgnach
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| Vol #:
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| 29
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| EC 488
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| North Pacific International
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| Vol #:
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| 29
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| EMC 203
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| M Foster
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| Vol #:
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| 29
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| EMC
204
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| La Poste
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| Vol #:
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| 29
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| EXT
2
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| The Scotch Whisky Association
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| Vol #:
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| 29
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| EXT
3
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| The Scotch Whisky Association
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| Vol #:
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| 29
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| TS 1
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| Number not used
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| Vol #:
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| 0
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| TS 2
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| Number not used
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| Vol #:
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| 0
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| 2003N-0342
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| Toll-Free Number
for Reporting Adverse Events on Labeling for Human Drug Products
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| NCR
1
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| FDA
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| Vol #:
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| 2
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| 2004D-0187
|
| Guidance for Industry
on Premarketing Risk Assessment
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|
|
|
|
| C
1
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| Risk Management Resources
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| Vol #:
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| 1
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| 2004D-0188
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| Guidance for Industry
on Development and Use of Risk Minimization Action Plans
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|
|
|
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| C
1
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| Risk Management Resources
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| Vol #:
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| 1
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|
|
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| 2004D-0189
|
| Guidance for Industry
on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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|
|
|
|
| C
1
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| Risk Management Resources
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| Vol #:
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| 1
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| 2004N-0086
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| Diabetes: Targeting
Safe and Effective Prevention and Treatment; Public Meeting
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| C 8
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| A. Andersson
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| Vol #:
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| 1
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| C
9
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| Paperboy Ventures, LLC
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| Vol #:
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| 1
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| 2004N-0221
|
| Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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|
|
|
|
| C
1
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| Rush University College of Medicine
|
| Vol #:
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| 1
|
|
|
|
|
| 2004P-0061
|
| Take actions to
establish guidance and clarify requirements for abbreviated new drug
applications with regard to levothyroxine sodium products
|
|
|
|
|
| SUP
1
|
| Abbott Laboratories (Abbott)
|
| Vol #:
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| 1
|
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| 2004P-0131
|
| ANDA Suitability
for Tofin (tobramycin for Inhalation)
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|
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|
|
| C
2
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| Drug Royalty Corporation, Inc.
(DRC)
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| Vol #:
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| 1
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| 2004P-0202
|
| Notify State &
Federal regulators of GRAS requirements of milk protein Concentrade
|
|
|
|
|
| C 4
|
| K. Darnmstadt
|
| Vol #:
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| 1
|
|
|
|
|
| 2004P-0206
|
| No abbreviated
new drug application (ANDA) for Fluticasone Propionate Nasel Spray
will be approval, unless it contains bioavailability and bioequivalence
studies
|
|
|
|
|
| LET
1
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0227
|
| Adhere to the statutory
limitations of section 505(j)(5)(B)(iv) of the Act in issuing final
approvals to ANDA applicants
|
|
|
|
|
| C
1
|
| Teva Pharmaceutical Industries
Ltd (Teva) and Purepac Pharmaceutical Co. (Purepac)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004V-0155
|
| Valley Forge Composite
Technologies Explosive Detection Systems
|
|
|
|
|
| CR
1
|
| R. Broadright
|
| Vol #:
|
| 1
|
|
