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| Dockets Entered
On May 23, 2007
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| Docket #
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| Title
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| 1997V-0470
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| Lazer Light Show
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| 2002P-0399
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| Determine Whether Estrostep 21 Tablets, NDA 020130 Have Been
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004E-0319
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| Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| 2006E-0260
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| Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
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| 2006E-0501
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| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
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| 2007E-0002
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| Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007N-0179
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| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
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| 2007N-0191
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| Determination That Protamine Sulfate Injection and 26 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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| 2007P-0110
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| To enforce pediatric exclusivity rights for amlodipine
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| 2007P-0111
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| Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity
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| 2007P-0211
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| requests a determination 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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| 1997V-0470
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| Lazer Light Show
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| VRA 5
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| FDA/CDRH to Lazer Onyx
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| 1
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| 2002P-0399
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| Determine Whether Estrostep 21 Tablets, NDA 020130 Have Been
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| N 1
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| FDA
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| 1
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 1025
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| The Center for Food Safety (CFS)
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| 106
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| C 1026
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| Margarette J. Cook
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| 68
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| 2004E-0319
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| Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
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| N 1
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| FDA
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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 9
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| Life Therapeutics
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| 1
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| 2006E-0260
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| Patent Extension Application for ORENCIA (abatacept), U.S. Patent No. 5,851,795
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006E-0501
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| Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
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| N 1
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| FDA
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| 1
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| 2007E-0002
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| Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
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| N 1
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| FDA
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| 1
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 217
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| Winterstein, Almut
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| Vol #:
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| 7
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| EAPE 218
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| Merchant, Susan
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| Vol #:
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| 7
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| EAPE 219
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| McManus, William
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| Vol #:
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| 7
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| EAPE 220
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| Sbarbaro, Jan
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| Vol #:
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| 7
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| 2007N-0179
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| Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
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| NM 1
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| FDA
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| 1
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| 2007N-0191
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| Determination That Protamine Sulfate Injection and 26 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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| N 1
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| FDA
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| 1
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| 2007P-0110
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| To enforce pediatric exclusivity rights for amlodipine
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| PDN 1
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| FDA/CDER/OGD to Pfizer, Inc.
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| 1
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| 2007P-0111
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| Stay approval of any and all supplements to Lotrel concerning amlodipine and pediatric exclusivity
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| PDN 1
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| FDA/CDER/OGD to Pfizer, Inc.
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| 1
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| 2007P-0211
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| requests a determination 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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| ACK 1
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| FDA / DDM to Sheppard Mullin Richter & Hampton LLP
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| Vol #:
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| 1
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| CP 1
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| Sheppard Mullin Richter & Hampton LLP
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| Vol #:
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| 1
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