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| Dockets Entered
On November 19, 2007
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| Docket
#
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| Title
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| 1993N-0162
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| NWL Abbreviated New Drug Applications
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1997N-0497
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| Allogeneic Peripheral and Placental/ Umbilical Cord Blood
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| 2006E-0252
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| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
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| 2006E-0356
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| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| 2007N-0382
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| Ramipril Capsules and 180-day generic drug exclusivity
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| 2007N-0417
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| Acarbose Tablets and 180-day exclusivity
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| 2007P-0209
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| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
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| 2007P-0211
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| Determine that the listed drugs, oxycodone hydrochloride extended release tablets, 15 mg, 30 mg, and 60 mg, were voluntarily withdrawn by Purdue Pharma LP, for reasonsother than safety
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| 2007P-0438
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| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
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| 2007P-0455
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| Revoke the Orphan Drug designation for Gestiva
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| 1993N-0162
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| NWL Abbreviated New Drug Applications
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| C 1
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| Julie A. Nicholas
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| 1
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 416
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| TJ Panorama, Inc
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| Vol #:
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| 329
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| 1997N-0497
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| Allogeneic Peripheral and Placental/ Umbilical Cord Blood
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| EMC 3
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| National Marrow Donor Program
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| 15
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| 2006E-0252
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| Patent Extension Application for LEVEMIR insulin detemir (rDNA origin) injection, U.S. Patent No. 5,750,497
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| LET 6
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| U.S. Patent and Trademark Office to Novo Nordisk, Inc.
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| 1
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| 2006E-0356
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| Patent Extension Application for BARACLUDE (entecavir), U.S. Patent No. 5,206,244
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| LET 6
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| U.S. Patent and Trademark Office to Bristol-Myers Squibb Company
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| 1
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| C 2
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| Connie and Donald Roux
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| 1
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| 2007N-0382
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| Ramipril Capsules and 180-day generic drug exclusivity
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| C 7
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| Kirkland & Ellis,
LLP
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| Vol #:
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| 1
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| 2007N-0417
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| Acarbose Tablets and 180-day exclusivity
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| C 2
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| Cobalt Laboratories & Cobalt Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| 2007P-0209
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| Not to grant final ANDA approval for any generic versions of Toprol-XL, metoprolol succinate extended-release tablets (metoprolol) 50, mg
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| LET 1
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| FDA/CDER to Sandoz,
Inc.
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| Vol #:
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| 1
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| 2007P-0211
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| Determine
that the listed drugs, oxycodone hydrochloride extended release tablets,
15 mg, 30 mg, and 60 mg, were voluntarily withdrawn by Purdue Pharma
LP, for reasonsother than safety
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| LET 1
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| FDA/CDER to Sheppard, Mullin, Richter & Hampton, LLP
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| 1
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| 2007P-0438
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| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
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| SUP 1
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| National Toxic Encephalopathy Foundation
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| Vol #:
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| 3
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| 2007P-0455
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| Revoke the Orphan Drug designation for Gestiva
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| ACK 1
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| FDA/DDM to Sidelines National Support Network
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| Vol #:
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| 1
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| CP 1
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| Sidelines National Support Network
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| Vol #:
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| 1
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