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Dockets Management

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that the listed drugs, oxycodone hydrochloride extended release tablets, 15 mg, 30 mg, and 60 mg, were voluntarily withdrawn by Purdue Pharma LP, for reasonsother than safety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

Page created on November 19, 2007 ue

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