| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On June 6, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 2001N-0548
|
| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| 2004P-0418
|
| Atorvastatin Calcium Capsules, 10mg, 20mg, 40mg, and 80mg for an abbreviated new drug application (ANDA)
|
|
|
|
|
| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
|
|
|
|
| 2005D-0103
|
| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
|
|
|
|
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
|
|
|
|
| 2005N-0097
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| 2005P-0134
|
| Concerning Marketing Exclusivity for Vitrase (NDA 21-64)
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
16138
|
| Inverness Medical Nutritional Group
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16139
|
| Advocare International, L.P.
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16140
|
| Alva-Amco Pharmacal Companies, Inc.
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16141
|
| Ajinomoto USA, inc.
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16142
|
| Ajinomoto USA, Inc.
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16143
|
| Ajinomoto USA, Inc.
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16144
|
| Pharmavite LLC
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16145
|
| Source Naturals
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16146
|
| Consumer's Choice
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16147
|
| FoodScience Corporation
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16148
|
| Phi-Ten USA, Inc.
|
| Vol #:
|
| 143
|
|
|
|
|
| LET
16149
|
| Advocare International, L.P.
|
| Vol #:
|
| 143
|
|
|
|
|
| 2001N-0548
|
| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
|
|
|
|
|
| C
11
|
| Califorina
|
| Vol #:
|
| 4
|
|
|
|
|
| C
12
|
| International Banana Association
|
| Vol #:
|
| 4
|
|
|
|
|
| C
13
|
| Sunkist
|
| Vol #:
|
| 4
|
|
|
|
|
| C
14
|
| Dole Food Company, Inc.
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| C 36
|
| D. and L. Hoag
|
| Vol #:
|
| 4
|
|
|
|
|
| C
37
|
| NCA and CMA
|
| Vol #:
|
| 4
|
|
|
|
|
| C
38
|
| Good Housekeeping
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004P-0418
|
| Atorvastatin Calcium Capsules, 10mg, 20mg, 40mg, and 80mg for an abbreviated new drug application (ANDA)
|
|
|
|
|
| WDL
1
|
| Lachman Consultant Srvices, Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2004P-0472
|
| refuse final approval to ANDA 76-258 for a generic fentanyl transdermal lsystem under it current proposed labeling
|
|
|
|
|
| C
7
|
| Cephalon, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005D-0103
|
| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
|
|
|
|
|
| C
10
|
| Department of Public Health HIV Vaccine Trials
|
| Vol #:
|
| 1
|
|
| |
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
|
|
|
|
| C
2
|
| Bristol-Myers Squibb
|
| Vol #:
|
| 1
|
|
|
|
|
| C
3
|
| Genentech
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0097
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| C
1
|
| Life Enhancement Prod., Inc., Life Extension Foundation Buyers Club, Inc., Durk Peason and others
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0134
|
| Concerning Marketing Exclusivity for Vitrase (NDA 21-64)
|
|
|
|
|
| C
1
|
| Amphastar Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
