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| Dockets Entered
On April 25, 2006
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| Docket #
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| Title
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| 1980N-0476
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| Antifungal Drug Products for OTC Human Use
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| 2004V-0155
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| Valley Forge Composite Technologies Explosive Detection Systems
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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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| 2005N-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| 2005P-0257
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| Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA
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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| 2005P-0408
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| Amend 21CFR101.5, Food; name and place of business of manufacturer, packer, or distributor
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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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| 2005Q-0297
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| Qualified Health Claim (QHC): Green Tea and Reduced Risk of Cardiovascular Disease
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| 2005Q-0298
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| Qualified Health Claim (QHC): 100% Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
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| 2006D-0066
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| Guidance for Industry and FDA Staff: Whole Grains Label Statements
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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| 2006N-0019
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| Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
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| 2006P-0173
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| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
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| 1980N-0476
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| Antifungal Drug Products for OTC Human Use
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| BKG 2
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| Background
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| 18
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| C 83
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| Lilly Research Laboratories (Lilly)
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| Vol #:
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| 9
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| EMC 10
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| Johnson & Johnson Pharmaceutical Research & Development, LLC
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| Vol #:
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| 9
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| C 1380
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| R. Cherney
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| Vol #:
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| 259
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1281
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| R. McGovern
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| Vol #:
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| 12
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| EMC 1282
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| No signature
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| Vol #:
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| 12
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| EMC 1283
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| R. McCauley
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| Vol #:
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| 12
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| EMC 1284
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| L. Cato
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| Vol #:
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| 12
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| 2003N-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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| C 2
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| Buchanan Ingersoll PC.
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| Vol #:
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| 1
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| EMC 5
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| Buchanan Ingersoll, PC
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| Vol #:
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| 1
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| LET 5
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| SAIC-Frederick, Inc.
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| Vol #:
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| 1
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| 2004V-0155
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| Valley Forge Composite Technologies Explosive Detection Systems
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| WDL 1
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| Valley Forge Composite Technologies
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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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| EMC 2
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| Amgen Regulatory
Affairs
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| Vol #:
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| 1
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| EMC 3
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| Amgen Regulatory Affairs
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| Vol #:
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| 1
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| EMC 4
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| EMC 5
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| Johnson & Johnson Pharmaceutical Research & Development, LLC
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| Vol #:
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| 1
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| 2005N-0347
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| Biological Products for Treatment of Rare Plasma Protein Disorders
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| EC 2
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| PPTA
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| Vol #:
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| 1
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| EMC 3
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| K. Rubenstrunk
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| Vol #:
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| 1
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| 2005P-0257
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| Methylphenidate Hydrochloride Extended Release Tablets, 72 mg, is suitable for submission as an ANDA
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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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| 2005P-0383
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| refuse to approve any ANDA for generic oral products containing oxandrolone until the expiration od that exclusitity peroid on June 20, 2008.
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| RC 1
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| Savient Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2005P-0408
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| Amend 21CFR101.5, Food; name and place of business of manufacturer, packer, or distributor
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| EC 3
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| Ms. Cornelia Tax
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| Vol #:
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| 1
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| LET 1
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| FDA/CFSAN to Dan M. Kelch
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| Vol #:
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| 1
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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 6865
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| S. A. Brerteil, MD
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| Vol #:
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| 112
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| C 6866
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| S. Myers
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| Vol #:
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| 112
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| C 6867
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| J. Millage-Tront
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| Vol #:
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| 112
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| C 6868
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| L. Sullivan
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| Vol #:
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| 112
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| C 6869
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| C. Loud
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| Vol #:
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| 112
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| C 6870
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| D. Monilll, RN, C, NP
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| Vol #:
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| 112
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| C 6871
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| K. Fraundorffer
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| Vol #:
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| 112
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| C 6872
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| K. O' Fallon
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| Vol #:
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| 112
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