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| Dockets Entered
On March 21, 2005
Table of Contents
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| Docket #
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| Title
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0290
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| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
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| 2004P-0488
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| Refrain from receiving, reviewing, and approving any ANDA for a nasal mupirocin calcium product that contains the amophous form of the active pharmaceutical ingredient.
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| SUP
38
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| Northfield Laboratories Inc BB IND 10719
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| Vol #:
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| 42
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 1121
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| Center for Veterinary Medicine
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| Vol #:
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| 443
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| EXB 1122
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| Center for Veterinary Medicine
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| Vol #:
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| 443
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| 2003P-0064
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| Withhold Approval of Generic Lovenox (enoxaparin sodium inje
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| RC
2
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| Aventis Pharmaceuticals Inc.
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| Vol #:
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| 3
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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| C
4
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| GlaxoSmithKline (GSK)
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| Vol #:
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| 1
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| C
15
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| Generic Pharmaceutical Assn (GPhA)
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| Vol #:
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| 4
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| 2004P-0290
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| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
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| SUP
2
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| Hogan & Hartson, LLP
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| Vol #:
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| 1
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| 2004P-0488
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| Refrain from receiving, reviewing, and approving any ANDA for a nasal mupirocin calcium product that contains the amophous form of the active pharmaceutical ingredient.
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| SUP
2
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| Hogan & Harston, LLP
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| Vol #:
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| 1
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