| | | | | | | | | | |
|
|
| Dockets Entered
On April 1, 2005
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1997P-0329
|
| Require Quantitative Labeling of Caffeine Content
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
| 2001N-0548
|
| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
|
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride Extended-Release Tablets
|
|
|
| 2003P-0551
|
| Citalopram Hydrobromide Capsules
|
|
|
| 2004D-0117
|
| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
|
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
| 2004N-0515
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
| 2004P-0247
|
| Escitalopram oxalate may be filed for ANDA capsule dosage form
|
|
|
| 2004P-0457
|
| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
|
|
|
| 2005N-0065
|
| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
|
|
|
| 2005N-0081
|
| Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems
|
|
|
| 2005P-0066
|
| ANDA Suitability for Amlodipine Besylate Capsules 2.5, 5, and 10mg
|
|
|
| 1997P-0329
|
| Require Quantitative Labeling of Caffeine Content
|
|
|
| C 261
|
| Donnie Brohm
|
| Vol #:
|
| 8
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
| C 758
|
| Shari VanEnkevort
|
| Vol #:
|
| 21
|
|
|
| EMC 593
|
| Bonita Poulin
|
| Vol #:
|
| 24
|
|
|
| EMC 594
|
| Michael J. Lees
|
| Vol #:
|
| 24
|
|
|
| EMC 595
|
| Erica Streit-Kaplan
|
| Vol #:
|
| 24
|
|
|
| 2001N-0548
|
| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
|
|
|
| BKG
2
|
| Background Material
|
| Vol #:
|
| 4
|
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride Extended-Release Tablets
|
|
|
| PAV
1
|
| HFD-600 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003P-0551
|
| Citalopram Hydrobromide Capsules
|
|
|
| PAV
1
|
| HFD-600 to Charles J. Raubicheck
|
| Vol #:
|
| 1
|
|
|
| 2004D-0117
|
| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
|
|
|
| GDL
2
|
| GUIDANCE
|
| Vol #:
|
| 1
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
| | | | | | | | |
|
|
| BKG
1
|
| Background Material
|
| Vol #:
|
| 2
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
| BKG
1
|
| Background Material
|
| Vol #:
|
| 2
|
|
|
| 2004N-0515
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004P-0247
|
| Escitalopram oxalate may be filed for ANDA capsule dosage form
|
|
|
| PAV
1
|
| HFD-600 to Charles J. Raubicheck
|
| Vol #:
|
| 1
|
|
|
| 2004P-0457
|
| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
|
|
|
| C
2
|
| ENDOTEC
|
| Vol #:
|
| 1
|
|
|
| 2005N-0065
|
| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
|
|
|
| EXT
1
Attachment
|
| National Fisheries Institute
|
| Vol #:
|
| 1
|
|
|
| 2005N-0081
|
| Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems
|
|
|
| BKG
1
|
| Bsckground Material
|
| Vol #:
|
| 1
|
|
|
| 2005P-0066
|
| ANDA Suitability for Amlodipine Besylate Capsules 2.5, 5, and 10mg
|
|
|
| SUP
1
|
| Foley & Lardner LLP
|
| Vol #:
|
| 1
|
|