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| Dockets Entered
On May 30, 2006
Table of Contents
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| Docket #
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| Title
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| 1991V-0150
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| Laser light show
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| 1998V-0152
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| Laser light show
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| 1999V-0125
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| Laser Light Show Laserium CSMX250
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| 2001P-0152
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| Determine that Neurontin capsules was not withdrawn for safe
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2002V-0521
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| Laser Light Show
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| 2004P-0150
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| ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen
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| 2004P-0523
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| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
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| 2004V-0380
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| Laser Light Show
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| 2005P-0167
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| Require Celgene Corporation to Revise the Labeling of Thalomid Capsules to Strengthen Warnings of the Potential for Serious Adverse Events
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| 2005P-0228
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| ANDA Suitability for Ranitidine Hydrochloride Suspension (15 mg base/mL)
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| 2005P-0319
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| Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets
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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-0495
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| Dietary supplement VI-28 TM clarifying, in writing, whether or not the dietary supplement , as detailed in the pre-market notification filed 18 August 2005
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| 2005V-0301
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| Laser Light Show
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| 2006N-0104
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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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-0186
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| Withdraw new drug application (NDA 21-179) for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg
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| 2006V-0073
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| Projector for a Laser Light Show
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| 2006V-0188
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| Laser Light Show
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| 2006V-0192
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| Laser Light Show
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| 1991V-0150
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| Laser light show
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| VRA 7
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| FDA/CDRH to Y.L.S. Productions
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| 1
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| 1998V-0152
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| Laser light show
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| VRA 4
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| FDA/CDRH to Magic Fire Laser Shows, L.L.C.
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| 1
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| 1999V-0125
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| Laser Light Show Laserium CSMX250
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| VRA 4
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| FDA/CDRH to Universal Orlando
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| Vol #:
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| 1
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| 2001P-0152
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| Determine that Neurontin capsules was not withdrawn for safe
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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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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| ANS 1
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| FDA to Honorable Paul S. Sarbanes
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| Vol #:
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| 45
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| ANS 2
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| FDA to Honorable Nate Berry
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| Vol #:
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| 45
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| C 537
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| C. Holland, Sr.
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| Vol #:
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| 45
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| C 538
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| M and R Rickard
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| Vol #:
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| 45
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| LET 10
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| Honorable P. Sarbanes
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| Vol #:
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| 45
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| LET 11
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| Honorable Nate Berry
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| Vol #:
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| 45
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| 2002V-0521
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| Laser Light Show
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| VRA 2
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| FDA/CDRH to White Star
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| Vol #:
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| 1
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| 2004P-0150
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| ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen
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| C 1
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| D. Lowe
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| Vol #:
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| 2
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| 2004P-0523
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| generic fluticasone propionate nasal spray products meet the same high standards of quality as GSK's brand-name product Flonase
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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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| 2004V-0380
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| Laser Light Show
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| VRA 1
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| FDA/CDRH to : Delta Marine
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| Vol #:
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| 1
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| 2005P-0167
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| Require Celgene Corporation to Revise the Labeling of Thalomid Capsules to Strengthen Warnings of the Potential for Serious Adverse Events
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| PAV 1
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| FDA/CDER to State of Connecticut
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| Vol #:
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| 2
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| 2005P-0228
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| ANDA Suitability for Ranitidine Hydrochloride Suspension (15 mg base/mL)
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| WDL 1
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| Lachman Consuting Services, Inc.
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| Vol #:
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| 1
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| 2005P-0319
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| Determination of PHENERGAN (Promethazine hydrochloride) 12.5mg and 50mg tablets
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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-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 11246
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| J. E. Goff
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| Vol #:
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| 146
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| C 11247
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| L. Head
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| Vol #:
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| 146
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| C 11248
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| R. Prigge
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| Vol #:
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| 146
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| C 11249
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| K. V. Kish
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| Vol #:
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| 146
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| C 11250
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| S. Wallin
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| Vol #:
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| 146
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| C 11251
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| L. Matarazzo
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| Vol #:
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| 146
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| C 11252
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| R. Medlin
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| Vol #:
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| 146
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| C 11253
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| C. Godfrey
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| Vol #:
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| 146
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| 2006N-0104
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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| C 1
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| Hospira Inc
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| Vol #:
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| 1
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| EC 1
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| Baxter Healthcare Corporation
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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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| SUP 2
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| Mylan Laboratories Inc.
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| Vol #:
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| 1
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| 2006P-0186
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| Withdraw new drug application (NDA 21-179) for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg
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| C 1
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| Genzyme Corporation
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| Vol #:
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| 1
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| 2006V-0073
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| Projector for a Laser Light Show
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| VRA 1
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| FDA/CDRH to Adventure Zone
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| Vol #:
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| 1
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| 2006V-0188
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| Laser Light Show
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| VRA 1
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| FDA/CDRH to Village Group International/Club Metropolis
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| Vol #:
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| 1
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| 2006V-0192
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| Laser Light Show
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| VRA 1
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| FDA/CDRH to New Life Church
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| Vol #:
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| 1
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