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| Dockets Entered
On November 19, 2004
Table of Contents
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| Docket #
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| Title
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| 2004D-0499
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| Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004P-0383
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| ANADA for different concentration of active in Ivermectin Pour-On for cattle
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| 2004P-0384
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| ANADA for Levamisole Hydrochloride for cattle and sheep
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| 2004P-0517
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| Stay approval of any ANDAs submitted by Ivax Pharmaceuticals, Inc., CorePharma LLC, or any other party for which CollaGenex's Periostat (doxycycline hyclate 20 mg)
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| 2004P-0518
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| ANDA for Terbutaline Sulfate Injection
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| NEC
3
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| FDA
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| Vol #:
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| 7
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| 1995P-0241
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| Implied Nutrient Content Claim 'Healthy' & Health Claims
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| NEC
3
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| FDA
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| 9
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14813
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14814
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14815
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14816
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14817
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| Enzmyatic Therapy
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| Vol #:
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| 130
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| LET
14818
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14819
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14820
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14821
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14822
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14823
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14824
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14825
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14826
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| Enzymatic Therapy
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| Vol #:
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| 130
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| LET
14827
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| Enzymatic Therapy
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| Vol #:
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| 130
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| C
1
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| Aventis Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004D-0499
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| Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
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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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| NAD
1
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| FDA
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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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| MO
2
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| GCF-1
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| Vol #:
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| 1
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| 2004P-0383
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| ANADA for different concentration of active in Ivermectin Pour-On for cattle
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| PAV
1
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| HFV-100 to Ancare New Zealand Ltd.
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| Vol #:
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| 1
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| 2004P-0384
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| ANADA for Levamisole Hydrochloride for cattle and sheep
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| PAV
1
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| HFV-100 to Ancare New Zealand Ltd.
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| Vol #:
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| 1
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| 2004P-0517
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| Stay approval of any ANDAs submitted by Ivax Pharmaceuticals, Inc., CorePharma LLC, or any other party for which CollaGenex's Periostat (doxycycline hyclate 20 mg)
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| ACK
1
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| HFA-305 to CollaGenex Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| PSA
1
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| CollaGenex Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004P-0518
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| ANDA for Terbutaline Sulfate Injection
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| ACK
1
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| HFA-305 to Ben Venue Laboratories
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| Vol #:
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| 1
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| CP
1
Attachment
1, 2
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| Ben Venue Laboratories
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| Vol #:
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| 1
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