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| Dockets Entered On May
1, 2006
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| Docket #
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| Title
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 1998V-0152
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| Laser light show
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| 2002P-0438
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| Warning on Labeling of Kava Dietary Supplements
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005P-0173
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| Request uniform professional labeling for Promethazine Hydrochloride Syrup, USP
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| 2005P-0182
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| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
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| 2005P-0282
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| Require Health Messages on Soft Drinks
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0456
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| Determine that the discontinued formulation Zosyn (piperacillin and tazobactam for injection), was not discontinued for safety and efficacy reasons
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| 2006P-0131
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| ANDA suitability for Epirubicin Hydrochloride
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| 2006P-0174
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| FDA to determine that any drug is therapeutically equivalent or AB-rated to BiDil (isosorbide dinitrate and hydralazine hydrochloride
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| 2006P-0177
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| ANDA Suitability for Methotrexate
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| 2006P-0178
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| Immediately ban fluoroquinolone antibiotic gatifloxacin in humans
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| 2006V-0176
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| Laser Light Show
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| C 11
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 1
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| C 12
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| Associacion de Exportadores
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| Vol #:
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| 1
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| 1998V-0152
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| Laser light show
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| EXP 3
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| Magic Fire LaserShows, LLC
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| Vol #:
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| 1
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| C 84
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| Lilly Research Laboratories (Lilly)
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| Vol #:
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| 9
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| 2002P-0438
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| Warning on Labeling of Kava Dietary Supplements
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| MT 1
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| FDA/CFSAN and Greenberg Traurig, LLP
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| Vol #:
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| 1
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| C 644
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| CGMP Coalition (the Coalition)
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| Vol #:
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| 11
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| C 645
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| Juice Products Association (JPA)
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| Vol #:
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| 11
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| OB 1
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| D. Lowe
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| Vol #:
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| 1
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| C 7
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| Lilly Research Laboratories (Lilly)
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| Vol #:
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| 2
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| EMC 6
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 2
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| EC 2
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| AstraZeneca
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| Vol #:
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| 1
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| EC 3
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| PDA
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| Vol #:
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| 1
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| EC 4
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| LearningPlus
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| Vol #:
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| 1
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| EC 5
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| Takeda Global Research and Development Center, Inc
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| Vol #:
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| 1
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| EC 6
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| Schering-Plough
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| Vol #:
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| 1
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| EC 7
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| Johnson
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| Vol #:
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| 1
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| EC 8
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| Sanofi Pasteur
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| Vol #:
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| 1
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| EC 9
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| Immel Resources LLC
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| LET 10
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| Eli Lilly and Company (Lilly)
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| Vol #:
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| 2
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| 2005P-0173
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| Request uniform professional labeling for Promethazine Hydrochloride Syrup, USP
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2005P-0182
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| Withdraw April 14, 2003, Warning Letter, CBER 03-010, addressed to Terry Fredeking, President, Antibody Systems, Inc., from the Warning Letters Web Page of FDA
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2005P-0282
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| Require Health Messages on Soft Drinks
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| C 24
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| Form Letters
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| Vol #:
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| 3
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 7612
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| D. Roester
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| Vol #:
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| 116
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| C 7613
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| G. L. Boles
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| Vol #:
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| 116
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| C 7614
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| G. Cardella
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| Vol #:
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| 116
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| C 7615
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| J. Forley
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| Vol #:
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| 116
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| C 7616
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| R. Selkowitz
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| Vol #:
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| 116
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| C 7617
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| V. Whiting
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| Vol #:
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| 116
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| C 7618
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| D. Sismer
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| Vol #:
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| 116
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| C 7619
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| C. Johnson
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| Vol #:
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| 116
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| C 7620
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| D. Gilbert
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| Vol #:
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| 116
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| C 21
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| Federal Rade Commission
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| Vol #:
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| 1
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| 2006P-0123
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| Request that all applicants for fentanyl transdermal systems conduct a study to support the safety of their fentanyl transdermal products
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0131
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| ANDA suitability for Epirubicin Hydrochloride
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| C 1
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| D. Lowe
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| Vol #:
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| 1
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| 2006P-0174
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| FDA to determine that any drug is therapeutically equivalent or AB-rated to BiDil (isosorbide dinitrate and hydralazine hydrochloride
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| WDL 1
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| FoxKiser
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| Vol #:
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| 1
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| 2006P-0177
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| ANDA Suitability for Methotrexate
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| ACK 1
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| HFA-305 to Sicor Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| CP 1
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| Sicor Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2006P-0178
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| Immediately ban fluoroquinolone antibiotic gatifloxacin in humans
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| ACK 1
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| HFA-305 to Public Citizen's Health Research Group
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| Vol #:
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| 1
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| CP 1
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| Public Citizen's Health Research Group
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| Vol #:
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| 1
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| 2006V-0176
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| Laser Light Show
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| ACK 1
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| HFA-395 to Tao Restaurant
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| Vol #:
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| 1
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| VAR 1
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| Tao Restaurant
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| Vol #:
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| 1
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