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| Dockets Entered
On May 7, 2004
Table of Contents
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| Docket
#
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| Title
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| 1995S-0117
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| Human Drugs Patent Term Extension & New Patents
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2003D-0206
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| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2003N-0205
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| Exocrine Pancreatic Insufficiency Drug Products
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| 2003N-0565
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys
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| 2004D-0146
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| Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds
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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-0159
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| Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| 2004P-0219
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| ANDA Suitability for Doxycycline Monohydrate Capsules, 150mg
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| 2004P-0220
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| determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
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| 2004V-0218
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| Laser Light Show
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| 1995S-0117
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| Human Drugs Patent Term Extension & New Patents
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| LST
92
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| List as of March 5, 2004
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| Vol #:
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| 7
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
13891
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13892
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13893
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13894
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13895
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13896
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13897
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13898
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13899
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13900
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13901
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13902
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13903
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13904
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13905
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| Enzymatic Therapy
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| Vol #:
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| 118
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| | | | | | | | |
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| LET
13906
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| Enzymatic Therapy
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| Vol #:
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| 118
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| LET
13907
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13908
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13909
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13910
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13911
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13912
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13913
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13914
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13915
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13916
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13917
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13918
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| Enzymatic Therapy
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| Vol #:
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| 119
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| LET
13919
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| Enzymatic Therapy
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| Vol #:
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| 119
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EMC 747
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| Lisa Wood
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| Vol #:
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| 271
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| EXB 32
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| CVM
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| Vol #:
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| 403
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| EXB 33
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| CVM
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| Vol #:
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| 403
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| EMC 5835
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| Maria Chambers
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| Vol #:
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| 789
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| EMC 5836
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| Maria Chambers
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| Vol #:
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| 789
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| EMC 5837
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| Carlos Guillermo
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| Vol #:
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| 789
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| 2003D-0206
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| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
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|
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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|
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| LST
1
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| Korangy Radiology Associates, P.A., et al
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| Vol #:
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| 2
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| LST
2
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| GCF-1
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| Vol #:
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| 2
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| 2003N-0205
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| Exocrine Pancreatic Insufficiency Drug Products
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| BKG
1
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| Background Information Refs
1 - 18
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| Vol #:
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| 1
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0565
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys
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| N
2
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| FDA
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| Vol #:
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| 1
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| | | | | | | | |
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| 2004D-0146
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| Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds
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|
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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|
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| NAD
1
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| FDA
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| Vol #:
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| 1
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|
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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|
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| NAD
1
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| FDA
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| Vol #:
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| 1
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|
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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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| GDL
1
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| Guideline
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| Vol #:
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| 1
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|
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| NAD
1
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| FDA
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| Vol #:
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| 1
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|
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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|
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| GDL
1
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| Guideline
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| Vol #:
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| 1
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|
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| NAD
1
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| FDA
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| Vol #:
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| 1
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|
|
| 2004N-0159
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| Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications
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|
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| NWL
1
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| FDA
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| Vol #:
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| 1
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|
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| BKG 1
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| Background Material Refs 1 - 16
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| Vol #:
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| 1
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|
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| NPR
1
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| FDA
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| Vol #:
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| 1
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|
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| 2004P-0219
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| ANDA Suitability for Doxycycline Monohydrate Capsules, 150mg
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| ACK 1
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| HFA-305 to Lachman Consultant Services, Inc.
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| Vol #:
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| 1
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| CP
1
Attachment
1, 2, 3
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| Lachman Consultant Services, Inc.
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| Vol #:
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| 1
|
|
|
| 2004P-0220
|
| determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
|
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| ACK 1
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| Wapner,Newman,Wigrizer,Brecher
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| Vol #:
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| 1
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| CP 1
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| Wapner,Newman,Wigrizer,Brecher
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| Vol #:
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| 1
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| 2004V-0218
|
| Laser Light Show
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|
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| ACK 1
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| HFA-305 to Dreamlight Laser Productions
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| Vol #:
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| 1
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| VAR
1
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| Dreamlight Laser Productions
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| Vol #:
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| 1
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|