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| Dockets Entered
On June 30, 2004
Table of Contents
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| Docket #
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| Title
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| 1993G-0017
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| Lactate is GRAS as a Color Fixative in Black Olives
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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-0206
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| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| 2003N-0539
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| Over-the-Counter Drug Products; Safety and Efficacy Review
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| 2003P-0160
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| FDA to send letter ruling refusing to approve loratadine tab
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| 2004D-0192
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| 2004N-0221
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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| 2004P-0075
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| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
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| 2004P-0105
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| Nutrient Content Claim: Total Carbohydrate Content of Foods
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| 2004P-0107
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| 2004P-0110
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| 2004P-0157
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| ANDA Suitability for Amoxicillin and Clavulanate Potassium Tablets for Oral Suspension 200 mg/28.5 mg and 400 mg/57 mg
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| 2004P-0243
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| Oxycodone and Acetaminophen tablet USP, 2.5 mg/400 mg. 5 mg/400 mg,7.5 mg/ 400 mg and 10 mg/400 mg
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| 1993G-0017
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| Lactate is GRAS as a Color Fixative in Black Olives
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| REF 6
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| Reference not used
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| Vol #:
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| 1
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 181
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 182
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 183
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 184
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 185
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 186
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 187
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 188
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 189
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 190
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 191
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 192
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 193
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 194
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 195
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 196
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 197
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 198
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 199
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 200
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| Center for Veterinary Medicine
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| Vol #:
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| 416
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| EXB 201
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 202
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 203
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 204
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 205
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 206
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 207
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| EXB 208
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| Center for Veterinary Medicine
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| Vol #:
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| 417
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 7493
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| J. A. Coleson
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| Vol #:
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| 280
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| EMC 7494
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| M. McPherson
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| Vol #:
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| 280
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| EMC 7495
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| John
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| Vol #:
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| 280
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| EMC 7496
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| K. Beder
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| Vol #:
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| 280
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| EMC 7497
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| J & C Jensen
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| Vol #:
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| 280
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| EMC 7498
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| R. Timberlake
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| Vol #:
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| 280
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| EMC 7499
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| R. Munt
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| Vol #:
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| 280
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| EMC 7500
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| M. Ditmyer
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| Vol #:
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| 280
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| EMC 7501
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| B. Shapiro
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| Vol #:
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| 280
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| EMC 7502
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| E. O'Connor
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| Vol #:
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| 280
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| EMC 7503
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| D. Tyrrell
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| Vol #:
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| 280
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| EMC 7504
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| E. C. Berigan, M. D
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| Vol #:
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| 280
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| EMC 7505
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| L. J. Navarro
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| Vol #:
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| 280
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| 2003D-0206
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| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
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| C
6
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| Scientific Protein Laboratories, LLC
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| Vol #:
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| 1
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| C
7
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| Eurand S.p.A.
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| Vol #:
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| 1
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| C
8
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| Meristem Therapeutics
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| Vol #:
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| 1
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| 2003D-0571
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| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| C
7
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| Aventis Pharmaceuticals, Inc. (Aventis)
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| Vol #:
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| 1
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| C
8
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| Active Pharmaceutical Ingredients Committee (APIC)
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| Vol #:
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| 1
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| C
9
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| Sandoz GmbH
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| Vol #:
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| 1
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| REF
1
Tab A, B,
C
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| OMB Review for April 22, 2004
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| Vol #:
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| 3
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| 2003N-0539
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| Over-the-Counter Drug Products; Safety and Efficacy Review
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| C
7
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| Consumer Healthcare Products Assn (CHPA)
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| 1
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| C
8
Tabs
1-8, Tab 9
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| CooperSurgical
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| Vol #:
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| 6
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| 2003P-0160
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| FDA to send letter ruling refusing to approve loratadine tab
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| PDN
1
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| HFD-1 to Frommer Lawrence & Haug LLP
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| Vol #:
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| 1
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| C
2
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| Aventis Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| C
2
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| Aventis Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| C
2
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| Aventis Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2004D-0192
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance
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| C
2
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| Indiana Blood Center
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| Vol #:
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| 1
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| 2004N-0018
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| Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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| REF
1
Tab A, Tab
B
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| OMB review for June 10, 2004
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| Vol #:
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| 2
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| 2004N-0221
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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| C
14
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| American Foundation for the Blind
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| Vol #:
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| 1
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| 2004P-0075
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| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
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| SUP
1
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| Mylan Pharmaceuticals Inc.
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| Vol #:
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| 1
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| 2004P-0105
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| Nutrient Content Claim: Total Carbohydrate Content of Foods
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| C
4
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| American Bakers Assn (ABA)
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| Vol #:
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| 1
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| 2004P-0107
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| C
4
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| American Bakers Assn (ABA)
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| Vol #:
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| 1
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| 2004P-0110
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| Nutrient Content Claim: Carbohydrate Content of Foods
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