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| Dockets Entered
On May 20, 2005
Table of Contents
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| Docket #
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| Title
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| 1977N-0231
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| PENICILLIN IN ANIMAL FEEDS
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| 1998D-0514
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| Industry on ANDA's: Impurities in Drug Substances
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 2002P-0312
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| Periostat (doxycycline hyclate) 20 mg Capsules
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| 2002P-0367
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| Doxycycline hyclate capsules 20mg,Periostat capsules,20mg
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| 2004D-0465
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| Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| 2004P-0153
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| ANDA Suitability for Oxycodone Hydrochloride Capsules for Oral administration, 5 mg, 10 mg, 20 mg, and 30 mg.
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| 2005D-0133
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| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2005P-0085
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| Provide a generic form of Endrate Disodium Injection, USP in secondary package configurations of a single box containing one vial and or trays containing twenty-five vials per tray
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| 2005P-0127
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| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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| 2005P-0139
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| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| 1977N-0231
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| PENICILLIN IN ANIMAL FEEDS
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| ANS 53
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| HF-1 to Hon Bill Archer
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| Vol #:
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| 3
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| ANS 54
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| HF-1 to Hon Sam B. Hall, Jr.
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| Vol #:
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| 3
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| ANS 55
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| HF-1 to Hon Sam B. Hall, Jr.
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| Vol #:
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| 3
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| ANS 56
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| HF-1 to Hon Ken Holland
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| Vol #:
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| 3
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| ANS 57
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| HF-1 to Hon Floyd Spence
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| Vol #:
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| 3
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| ANS 58
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| HF-1 to Hon Floyd D. Spence
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| Vol #:
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| 3
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| ANS 59
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| HF-1 to Hon Bill Hefner
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| Vol #:
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| 3
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| ANS 60
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| HF-1 toHon Bill Archer
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| Vol #:
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| 3
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| ANS 61
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| HF-1 to Hon Olin E. Teague
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| Vol #:
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| 3
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| ANS 62
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| HF-1 to Hon William M. Ketchum
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| Vol #:
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| 3
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| ANS 63
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| HF-1 to Hon Ed Jones
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| Vol #:
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| 3
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| ANS 64
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| HF-1 to Hon James T. Broyhill
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| Vol #:
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| 3
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| ANS 65
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| HF-1 to Hon James M. Hanley
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| Vol #:
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| 3
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| ANS 66
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| HFW-1 to Hon Addlai E. Stevenson
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| Vol #:
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| 3
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| ANS 67
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| HFW-1 toHon Adlai E. Stevenson
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| Vol #:
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| 3
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| ANS 68
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| HFW-1 to Hon Robert P. Griffin
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| Vol #:
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| 3
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| ANS 69
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| HFW-1 to Hon Robert P. Griffin
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| Vol #:
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| 3
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| ANS 70
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| HFW-1 to Hon Edmund S. Muskie
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| Vol #:
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| 3
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| ANS 71
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| HFW-1 to Hon Russell Long
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| Vol #:
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| 3
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| ANS 72
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| HFW -1 to Hon Jake Garn
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| Vol #:
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| 3
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| ANS 73
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| HFW-1 to Hon Eldon Rudd
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| Vol #:
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| 3
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| ANS 74
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| HFW-1 to Hon Howard W. Cannon
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| Vol #:
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| 3
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| ANS 75
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| HFW-1 to Hon Edward Zorinsky
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| Vol #:
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| 3
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| ANS 76
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| HFW-1 to Hon William Proxmire
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| Vol #:
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| 3
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| 1998D-0514
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| Industry on ANDA's: Impurities in Drug Substances
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| C
9
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 1
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7482
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| F. Castner
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| Vol #:
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| 319
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| C 7483
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| J. Williams
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| Vol #:
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| 319
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| C 18229
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| C. Stirling
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| Vol #:
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| 516
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| 2002P-0312
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| Periostat (doxycycline hyclate) 20 mg Capsules
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| LET
4
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| HFD-007 to CollaGenex Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2002P-0367
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| Doxycycline hyclate capsules 20mg,Periostat capsules,20mg
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| LET
4
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| HFD-7 to West-Ward Pharmaceutical Corp.
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| Vol #:
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| 1
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| 2004D-0465
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| Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
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| C
2
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| U.S. Pharmacopeia
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| Vol #:
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| 1
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| LST
1
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| GCF-1
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| Vol #:
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| 1
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| STP
1
Tab
A, Tab
B
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| HFZ-215, et al.
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| Vol #:
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| 1
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| C
6
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| Pediatric Pharmacology Research Unit Network
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| Vol #:
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| 2
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| C 50
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| G. Mondrut
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| Vol #:
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| 5
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| 2004N-0527
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| Medical Devices; Medical Device Reporting
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| C
5
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| Siemens Medical Solutions USA, Inc. (SIEMENS)
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| Vol #:
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| 1
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| 2004P-0153
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| ANDA Suitability for Oxycodone Hydrochloride Capsules for Oral administration, 5 mg, 10 mg, 20 mg, and 30 mg.
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| PDN
1
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| HFD-600 to The Weinberg Group Inc.
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| Vol #:
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| 1
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| 2005D-0047
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| Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
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| C
1
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| Wyeth Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| C
2
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| AIDS Vaccine Advocacy Coalition (AVAC)
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| Vol #:
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| 1
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| 2005D-0133
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| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
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| C
1
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| National Hemophilia foudation (NHF)
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| Vol #:
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| 1
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| C 4
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| P. Singer, M.D.
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| Vol #:
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| 1
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| 2005P-0085
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| Provide a generic form of Endrate Disodium Injection, USP in secondary package configurations of a single box containing one vial and or trays containing twenty-five vials per tray
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| WDL
1
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| McGuff Pharmaceuticals Inc.
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| Vol #:
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| 1
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| 2005P-0127
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| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
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| C
2
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| Olsson, Frank and Weeda, P.C.
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| Vol #:
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| 2
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| 2005P-0139
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| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
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| EMC 1
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| Form Letter
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| Vol #:
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| 2
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