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| Dockets Entered
On April 27, 2004
Table of Contents
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| Docket
#
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| Title
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| 1976N-0151
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| Isocarboxazid
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| |
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| 1977N-0203
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| Tranylcypromine Sulfate
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| |
|
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| |
|
|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
|
| 1999D-0529
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| Draft Guidance for Ind - Changes to an Approved NDA or ANDA
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| |
|
|
| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| |
|
|
| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
|
|
| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| |
|
|
| 2003D-0570
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| Draft on the Clinical Evaluation of Weight-Control Drugs
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| |
|
|
| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| |
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| |
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| 2004N-0115
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| Prescription Drug Importation Study
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| |
|
|
| 2004N-0176
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| Preparation for the International Conference on Harmonization Meetings in Washington, DC: Public Meeting
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| |
|
|
| 2004P-0105
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| Nutrient Content Claim: Total Carbohydrate Content of Foods
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| |
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|
| 2004P-0107
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| |
|
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| 2004P-0110
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| |
|
|
| 2004P-0167
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| ANADA for a generic equivalent of the innovator products, Garacin (gentamicin sulfate) Pig Pump Oral Solution
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| |
|
|
| 2004P-0183
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| Nutrient Content Claim: Expand Lean Definition
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| |
|
|
| 2004P-0195
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| ANDA Suitability for Divalproex Sodium Extended-Release Tablets, 750 mg
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| |
|
|
| 2004P-0196
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| ANDA for ribavirin, USP tablets in stengths of 400 mg and 600mg
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| |
|
|
| 2004P-0197
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| ANADA for Pig Pump Oral Solution, NADA 130-464
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|
| |
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| 1976N-0151
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| Isocarboxazid
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| |
|
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| NPH
2
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| FDA
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| Vol #:
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| 1
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| |
|
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| 1977N-0203
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| Tranylcypromine Sulfate
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| |
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| NPH
2
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| FDA
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| Vol #:
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| 1
|
| |
|
|
| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| |
|
|
| RPT
177
Attachments
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| Hi Tech Pharma Inc
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| Vol #:
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| 132
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| |
|
|
| RPT
178
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| Exceeding Corp.
|
| Vol #:
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| 132
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| |
|
|
| RPT
179
Attachments
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| BSP Pharm A/S
|
| Vol #:
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| 132
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| |
|
|
| RPT
180
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| Cyber Store LLC
|
| Vol #:
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| 133
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| |
|
|
| RPT
181
Attachments
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| Advanced Orthomolecular Research
|
| Vol #:
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| 133
|
| |
|
|
| RPT
182
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| Amino GmbH
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| Vol #:
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| 134
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| |
|
|
| RPT
183
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| Hormo Nutraceutical Oy Ltd
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| Vol #:
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| 133
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| RPT
184
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| Mark Weiner
|
| Vol #:
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| 133
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| | | | | | | | |
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|
| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
|
|
| LET
13795
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 117
|
| |
|
|
| LET
13796
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| Herb Pharm
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| Vol #:
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| 117
|
| |
|
|
| LET
13797
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| Perrigo Company of South Carolina
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| Vol #:
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| 117
|
| |
|
|
| LET
13798
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| Perrigo Company of South Carolina
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| Vol #:
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| 117
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| |
|
|
| LET
13799
|
| Perrigo Company of South Carolina
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| Vol #:
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| 117
|
| |
|
|
| LET
13800
|
| Perrigo Company of South Carolina
|
| Vol #:
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| 117
|
| |
|
|
| LET
13801
|
| Perrigo Company of South Carolina
|
| Vol #:
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| 117
|
| |
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|
| LET
13802
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| EuroPharma, Inc.
|
| Vol #:
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| 117
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| |
|
|
| LET
13803
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| Perrigo Company of South Carolina
|
| Vol #:
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| 117
|
| |
|
|
| LET
13804
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| Optimum Nutrition
|
| Vol #:
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| 117
|
| |
|
|
| LET
13805
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| Melaleuca, Inc.
|
| Vol #:
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| 117
|
| |
|
|
| LET
13806
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| Source Naturals
|
| Vol #:
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| 117
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| |
|
|
| LET
13807
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| Flora, Inc.
|
| Vol #:
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| 117
|
| |
|
|
| LET
13808
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| Weleda, Inc.
|
| Vol #:
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| 117
|
| |
|
|
| LET
13809
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| FoodScience of Vermont
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| Vol #:
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| 117
|
| |
|
|
| LET
13810
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| Botanical Laboratories
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| Vol #:
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| 117
|
| |
|
|
| LET
13811
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 117
|
| |
|
|
| LET
13812
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 117
|
| |
|
|
| LET
13813
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 117
|
| |
|
|
| LET
13814
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| NBTY, Inc.
|
| Vol #:
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| 117
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| |
|
|
| LET
13815
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| NBTY, Inc.
|
| Vol #:
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| 117
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| |
|
|
| LET
13816
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| NBTY, Inc.
|
| Vol #:
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| 117
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| |
|
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| LET
13817
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| NBTY, Inc.
|
| Vol #:
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| 117
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| |
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|
| LET
13818
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| NBTY, Inc.
|
| Vol #:
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| 117
|
| |
|
|
| LET
13819
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| NBTY, Inc.
|
| Vol #:
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| 117
|
| |
|
|
| LET
13820
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| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 117
|
| |
|
|
| LET
13821
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 117
|
| |
|
|
| LET
13822
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
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| 117
|
| |
|
|
| LET
13823
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| Synergy Worldwide
|
| Vol #:
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| 117
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| |
|
|
| LET
13824
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 117
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| |
|
|
| LET
13825
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| Nutrivention Nutritional Programs
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| Vol #:
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| 117
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| |
|
|
| LET
13826
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| Pharmanex, LLC
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| Vol #:
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| 117
|
| |
|
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| LET
13827
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| NBTY, Inc.
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| Vol #:
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| 117
|
| |
|
|
| LET
13828
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| NBTY, Inc.
|
| Vol #:
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| 117
|
| |
|
|
| LET
13829
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| NBTY, Inc.
|
| Vol #:
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| 117
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|
| | | | | | | | |
| |
|
|
| LET
13830
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| NBTY, Inc.
|
| Vol #:
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| 117
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| |
|
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| LET
13831
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| NBTY, Inc.
|
| Vol #:
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| 117
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| |
|
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| LET
13832
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| NBTY, Inc.
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| Vol #:
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| 117
|
| |
|
|
| LET
13833
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| NBTY, Inc.
|
| Vol #:
|
| 117
|
| |
|
|
| LET
13834
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| NBTY, Inc.
|
| Vol #:
|
| 117
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| |
|
|
| LET
13835
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| Advocare International, L.P.
|
| Vol #:
|
| 117
|
| |
|
|
| 1999D-0529
|
| Draft Guidance for Ind - Changes to an Approved NDA or ANDA
|
| |
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 5
|
| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
| |
|
|
| EMC 667
|
| Form Letter
|
| Vol #:
|
| 402
|
| |
|
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| EMC 668
|
| Sandy McClure
|
| Vol #:
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| 271
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| |
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| EMC 669
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| Joseph Staples
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| Vol #:
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| 271
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| |
|
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| EMC 670
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| Diane Lindahl
|
| Vol #:
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| 271
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| |
|
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| EMC 671
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| Nathan Bixby
|
| Vol #:
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| 271
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| |
|
|
| EMC 672
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| Yolanda Garcia
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 673
|
| Laurel Kearns
|
| Vol #:
|
| 271
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| |
|
|
| EMC 674
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| David Beumee
|
| Vol #:
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| 271
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| |
|
|
| EMC 675
|
| Kathy Carson
|
| Vol #:
|
| 271
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| |
|
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| EMC 676
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| Andy Belk
|
| Vol #:
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| 271
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| |
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| EMC 677
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| Clare Loftin
|
| Vol #:
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| 271
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| |
|
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| EMC 678
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| Patricia Donovan
|
| Vol #:
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| 271
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| |
|
|
| EMC 679
|
| Jef Cameron-Martin
|
| Vol #:
|
| 271
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| |
|
|
| EMC 680
|
| Joan Walker
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 681
|
| Ron Carswell
|
| Vol #:
|
| 271
|
| |
|
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| EMC 682
|
| Marie Ryan
|
| Vol #:
|
| 271
|
| |
|
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| EMC 683
|
| Darius Sivin
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 684
|
| Rev. Roger Wolsey
|
| Vol #:
|
| 271
|
| |
|
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| EMC 685
|
| Arthur Fitzgerald
|
| Vol #:
|
| 271
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| |
|
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| EMC 686
|
| Michael Stites
|
| Vol #:
|
| 271
|
| |
|
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| EMC 687
|
| Kay James
|
| Vol #:
|
| 271
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| |
|
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| EMC 688
|
| Lois Joseph
|
| Vol #:
|
| 271
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| |
|
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| EMC 689
|
| Bill & Marilyn Voohies
|
| Vol #:
|
| 271
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| |
|
|
| EMC 690
|
| Deborah Nation
|
| Vol #:
|
| 271
|
| |
|
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| EMC 691
|
| Lynda Bagot-Parker
|
| Vol #:
|
| 271
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| |
|
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| EMC 692
|
| Ann Hansen
|
| Vol #:
|
| 271
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|
| | | | | | | |
| |
|
|
| EMC 693
|
| Bob Fischella
|
| Vol #:
|
| 271
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| |
|
|
| EMC 694
|
| Harry Rothwell
|
| Vol #:
|
| 271
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| |
|
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| EMC 695
|
| Barbara Jones
|
| Vol #:
|
| 271
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| |
|
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| EMC 696
|
| Diane Wonio
|
| Vol #:
|
| 271
|
| |
|
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| EMC 697
|
| Eleen Onda
|
| Vol #:
|
| 271
|
| |
|
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| EMC 698
|
| Richard Haberstroh
|
| Vol #:
|
| 271
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| |
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| EMC 699
|
| Patricia R. Hopkins
|
| Vol #:
|
| 271
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| |
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| EMC 700
|
| Ann Berquist
|
| Vol #:
|
| 271
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| |
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| EMC 701
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| Michele A. Carson
|
| Vol #:
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| 271
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| |
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| EMC 702
|
| Frances Perlman
|
| Vol #:
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| 271
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| |
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| EMC 703
|
| Dolly Kaplan
|
| Vol #:
|
| 271
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| |
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| EMC 704
|
| Kristi Herlein
|
| Vol #:
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| 271
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| |
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| EMC 705
|
| Barry Sapp
|
| Vol #:
|
| 271
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| |
|
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| EMC 706
|
| Nina Olff
|
| Vol #:
|
| 271
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| |
|
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| EMC 707
|
| Ocie Hudson
|
| Vol #:
|
| 271
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| |
|
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| EMC 708
|
| Karen McAnnally
|
| Vol #:
|
| 271
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| |
|
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| EMC 709
|
| Jessica Goodwin
|
| Vol #:
|
| 271
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| |
|
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| EMC 710
|
| Jennifer Heavilin
|
| Vol #:
|
| 271
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| |
|
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| EMC 711
|
| Diane Nunn
|
| Vol #:
|
| 271
|
| |
|
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| EMC 712
|
| Rev. B. J. Doucet
|
| Vol #:
|
| 271
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| |
|
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| EMC 713
|
| John Thomson
|
| Vol #:
|
| 271
|
| |
|
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| EMC 714
|
| Katherine Kilroy
|
| Vol #:
|
| 271
|
| |
|
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| EMC 715
|
| Benjamin Israel
|
| Vol #:
|
| 271
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| |
|
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| EMC 716
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| Rachel West
|
| Vol #:
|
| 271
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| |
|
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| EMC 717
|
| William Frazier
|
| Vol #:
|
| 271
|
| |
|
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| EMC 718
|
| Carole Zdesar
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 719
|
| Scott Bruins
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 720
|
| Barbara Ann Dembek, M.A.
|
| Vol #:
|
| 271
|
| |
|
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| EMC 721
|
| Dale Ann Cox
|
| Vol #:
|
| 271
|
| |
|
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| EMC 722
|
| Kirk Jacobsen
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 723
|
| J. K. Fort-Strietzel
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 724
|
| Pat Blair
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 725
|
| Robert Loucks
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 726
|
| Dorothea Herron
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 727
|
| Peter Rickwood
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 728
|
| Patrick Sullivan
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 729
|
| Janet Chavez
|
| Vol #:
|
| 271
|
|
| | | | | | | | |
| |
|
|
| EMC 730
|
| Christina Shepherd
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 731
|
| Corinne Canavero
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 732
|
| Melissa Huling
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 733
|
| Sherry Price
|
| Vol #:
|
| 271
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EMC 6101
|
| S. Abbott
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6102
|
| Mrs. F. M. Cone
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6103
|
| N. Jentz
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6104
|
| E. Hollingshead
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6105
|
| K. Berra
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6106
|
| M. Gillespie
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6107
|
| J. Cloud
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6108
|
| J. Burgderfer
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6109
|
| E. R. Greenspan
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6110
|
| Jenny C.
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6111
|
| L. H. Madsen
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6112
|
| J. Titus
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6113
|
| R. L. Nicolay
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6114
|
| R. Rallo
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6115
|
| J. Brinn
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6116
|
| J. Thoms
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6117
|
| B. Linsey
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6118
|
| G. Toomey
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6119
|
| J. Busbey
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6120
|
| P. Griffith
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6121
|
| B. Dayton
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6122
|
| B. Noehl
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6123
|
| J. Kobran
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6124
|
| A. Magee
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6125
|
| D. Cabrera
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6126
|
| T. Keenan
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6127
|
| V. Goodrich
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6128
|
| R. Taylor
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6129
|
| C. Stoltz
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6130
|
| M. Fong
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6131
|
| D. Dobric
|
| Vol #:
|
| 234
|
|
| | | | | | | | |
| |
|
|
| EMC 6132
|
| J. Robbins
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6133
|
| L. Woodry
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6134
|
| B. Allen
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6135
|
| P. Gassner
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6136
|
| S. Fisher
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6137
|
| A. H. Lerner, M.D.
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6138
|
| L. Nastro
|
| Vol #:
|
| 245
|
| |
|
|
| EMC 6139
|
| J. T. Carlson
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6140
|
| B. Noble
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6141
|
| B. J. McLendon
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6142
|
| J. Cahill-Dutiel
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6143
|
| A. Steeneck
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6144
|
| C. Mayes
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6145
|
| W. Velez
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6146
|
| J. Barrett
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6147
|
| A. Watts
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6148
|
| C. Ferguson
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6149
|
| E. Charlton
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6150
|
| F. Slater
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6151
|
| I. L. Else
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6152
|
| W. Bowman
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6153
|
| T. Marafiote
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6154
|
| B. Stewart
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6155
|
| L.Parker
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6156
|
| J. Burean
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6157
|
| J. Brann
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6158
|
| M. Leavitt
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6159
|
| S. Berzac
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6160
|
| A. Corbett
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6161
|
| J. Sina
|
| Vol #:
|
| 234
|
| |
|
|
| 2003D-0478
|
| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
|
| |
|
|
| C
69
|
| PFab, LP, d/b/a PharmaFab
|
| Vol #:
|
| 5
|
| |
|
|
| 2003D-0570
|
| Draft on the Clinical Evaluation of Weight-Control Drugs
|
| |
|
|
| C
4
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| Nastech Pharmaceutical Company, Inc. (NASTECH)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| C
6
|
| Hoffmann-La Roche Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| C
7
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
| |
|
|
| C
8
|
| Johnson & Johnson Pharmaceutical Research & Development, LLC
|
| Vol #:
|
| 1
|
| |
|
|
| C
9
|
| Amylin Pharmaceuticals, Inc. (AMYLIN)
|
| Vol #:
|
| 1
|
| |
|
|
| C
10
|
| Pfizer, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
| |
|
|
| C 11
|
| R and A Harper
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
| |
|
|
| C
3
|
| Center for Medical Consumers
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| Center for Medical Consumers
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
| |
|
|
| APE 19
|
| Consumer Alert
|
| Vol #:
|
| 3
|
| |
|
|
| 2004N-0176
|
| Preparation for the International Conference on Harmonization Meetings in Washington, DC: Public Meeting
|
| |
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0105
|
| Nutrient Content Claim: Total Carbohydrate Content of Foods
|
| |
|
|
| C
1
|
| Kevin Asip
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| HFS-200 to Kraft Foods North America, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0107
|
| Nutrient Content Claim: Carbohydrate Content of Foods
|
| |
|
|
| C
1
|
| K. Asip
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| HFS-200 to Office of Product Quality and Development
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0110
|
| Nutrient Content Claim: Carbohydrate Content of Foods
|
| |
|
|
| C
1
|
| K. Asip
|
| Vol #:
|
| 1
|
| |
|
|
| LET
1
|
| HFS-200 to Grocery Manufacturers of America
|
| Vol #:
|
| 1
|
| |
|
|
| LET
2
|
| HFS-200 to Grocery Manufacturers of America
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0167
|
| ANADA for a generic equivalent of the innovator products, Garacin (gentamicin sulfate) Pig Pump Oral Solution
|
| |
|
|
| WDL
1
|
| First Priority, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0183
|
| Nutrient Content Claim: Expand Lean Definition
|
| |
|
|
| ACK
1
|
| HFS-832 to Nestle Prepared Foods Company
|
| Vol #:
|
| 1
|
| |
|
|
| C
1
|
| C. Williams,MD,MPH
|
| Vol #:
|
| 4
|
| |
|
|
| CP
1
Petition,
Attachments
|
| Nestle Prepared Foods Company (Nestle)
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0195
|
| ANDA Suitability for Divalproex Sodium Extended-Release Tablets, 750 mg
|
|
| | | | | | | | |
| |
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0196
|
| ANDA for ribavirin, USP tablets in stengths of 400 mg and 600mg
|
| |
|
|
| ACK 1
|
| HFA-305 to Fommer Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Tabs
|
| Fommer Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0197
|
| ANADA for Pig Pump Oral Solution, NADA 130-464
|
| |
|
|
| ACK 1
|
| HFA-305 to First Priority, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| First Priority, Inc.
|
| Vol #:
|
| 1
|
|
|
