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| Dockets Entered
On July 8, 2005
Table of Contents
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| Docket #
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| Title
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| 2004P-0013
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| Review safety of Nutropin Depot Injection, issue direction to Genentech Inc. to add warnings regarding diabetes in their safety literature, and consider amending 21 CFR 314.80(e) Postmarketing studies
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| 2004P-0068
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| Establish specific bioequivalence requirements for oral products contanining desmopressin
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| 2005N-0137
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| Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
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| 2005N-0276
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| prior notice and recordkeeping requirements (21 CFR Part 1,subpart I and J) to food samples for quality assurance,research, or analysis purposes
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| 2005P-0170
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| ANADA for a generic ivermectin soft chew that differs in dosage form for horses
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| 2005P-0277
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| ANADA Suitability for generic version of EXCENEL RTU, ceftiofur hydrochloride sterile suspension
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| 2005P-0278
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| prior notice of imports (21 CFR part 1,subpart I) and establishment and maintenance of records (21CFR Part 1,subpart J).
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| EMC
15
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| Food Research Inc (California Kiwifruit Commission, Chilean Fresh Fruit Association, et al
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| Vol #:
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| 5
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| EMC
16
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| University of Hawaii at Manoa
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| Vol #:
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| 5
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| EMC
17
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| University of Hawaii at Manoa
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| Vol #:
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| 5
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| EMC
18
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| China WTO/TBT National Notification & Enquiry Center
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| Vol #:
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| 5
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| EMC
19
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| Produce for Better Health Foundation (PBH)
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| Vol #:
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| 5
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| EMC
20
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| U S Apple Association
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| Vol #:
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| 5
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| EMC
21
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| California Strawberry Commission (CSC)
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| Vol #:
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| 5
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| EMC
22
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| United Fresh Fruit and Vegetable Association
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| Vol #:
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| 5
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| EMC
23
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| National Watermelon Promotion Board
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| Vol #:
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| 5
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| 2004P-0013
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| Review safety of Nutropin Depot Injection, issue direction to Genentech Inc. to add warnings regarding diabetes in their safety literature, and consider amending 21 CFR 314.80(e) Postmarketing studies
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| SUP
1
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| Consumer
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| 1
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| 2004P-0068
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| Establish specific bioequivalence requirements for oral products contanining desmopressin
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| REF
1
Appendix
1
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| HFD-1 re: NDA 19-955 (Review of Two Pharmacokinetic Studies in a new NDA)
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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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| EXT
1
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2005N-0276
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| prior notice and recordkeeping requirements (21 CFR Part 1,subpart I and J) to food samples for quality assurance,research, or analysis purposes
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| CP 1
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| number not used
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| Vol #:
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| 1
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| 2005P-0170
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| ANADA for a generic ivermectin soft chew that differs in dosage form for horses
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| PAV
1
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| HFV-1 to Intervet, Inc
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| Vol #:
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| 1
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| 2005P-0277
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| ANADA Suitability for generic version of EXCENEL RTU, ceftiofur hydrochloride sterile suspension
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| ACK
1
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| HFA-305 to Pfizer Animal Health
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| Vol #:
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| 1
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| CP
1
Attachment
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| Pfizer Animal Health
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| Vol #:
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| 1
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| 2005P-0278
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| prior notice of imports (21 CFR part 1,subpart I) and establishment and maintenance of records (21CFR Part 1,subpart J).
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| ACK
1
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| HFA-305 to National Institute of Oilseed Products
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| Vol #:
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| 1
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| CP
1
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| National Institute of Oilseed Products
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| Vol #:
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| 1
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