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| Dockets Entered
On June 28, 2006
Table of Contents
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| Docket #
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| Title
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| 1995V-0105
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| Laser Light Show
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| 1996V-0432
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| Laser light show application
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| 2002V-0183
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| Laser Light Show
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| 2003V-0426
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| Laser Light Show
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 2005P-0046
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| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
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| 2005P-0072
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| Withholding of safety information regarding risks of Steven s Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Ibuprofen products
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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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-0509
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| Evaluation the warning to Consumers that Psychosis Is a possible adverse effect of Keppra (levetiracetam)
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| 2005V-0368
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| Projector for a Laser Light Show for Flare F1-1104; Flint: F2-0104; Firefly : F3-0905
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| 2006D-0254
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| Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds
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| 2006D-0268
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| Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer (DTC) Print Adver
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| 2006P-0001
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| Date of Approval for Lunesta (Eszopiclone) Tablets
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| 2006P-0047
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| Refrain from Approval any ANDA for Celestone Soluspan
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| 2006P-0241
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| Appeal District Court Civil Action No. 05-1838 (RWR) and deny the citzen petitions of Ivax and Ranbaxy
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| 2006P-0258
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| Immediately approve ANDA No. 77-837 upon the June 23, 2006 patent expiration of U.S. Patent No. 4,444,784
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| 2006V-0111
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| Projector for a Laser Light Show
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| 2006V-0153
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| Variance for Hair Removal System
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| 2006V-0155
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| Laser Light Show
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| 2006V-0248
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| Laser Light Show
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| 1995V-0105
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| Laser Light Show
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| VRA 6
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| FDA/CDRH to Stellar Designs, Inc.
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| 1
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| 1996V-0432
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| Laser light show application
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| VRA 3
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| FDA/CDRH to N Effect Production
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| 1
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| 2002V-0183
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| Laser Light Show
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| CR 1
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| FDA/DDM to Funzalosound
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| Vol #:
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| 1
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| 2003V-0426
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| Laser Light Show
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| VRA 3
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| FDA/CDRH to Celebration City
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| 1
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| LET 3
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| FDA/CDER to Ivax Pharmaceuticals, Inc.
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| Vol #:
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| 2
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| C 13820
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| Mrs. J. Gaughan
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| Vol #:
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| 159
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| C 13821
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| G. Stevens
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| Vol #:
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| 159
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| C 13822
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| P. Lee
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| Vol #:
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| 159
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| C 13823
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| J. G. Gervais
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| Vol #:
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| 159
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| C 13824
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| C. Jantzen
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| Vol #:
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| 159
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| C 13825
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| C. Van Poznak
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| Vol #:
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| 159
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| C 13826
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| K. LaCroix
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| Vol #:
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| 159
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| C 13827
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| M. Robinson
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| Vol #:
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| 159
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| C 13828
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| L. Sinnwell
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| Vol #:
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| 159
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| C 13829
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| J. Anderson
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| Vol #:
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| 159
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| C 13830
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| K. Yonkers
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| Vol #:
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| 159
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| C 13831
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| K. Kendall
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| Vol #:
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| 159
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| C 13832
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| L. Wilson
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| Vol #:
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| 159
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| C 13833
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| S. Wanamaker
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| Vol #:
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| 159
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| C 13834
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| J. Hunerberg
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| Vol #:
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| 159
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| C 13835
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| K. S. Fabian
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| Vol #:
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| 159
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| C 13836
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| J. Berman
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| Vol #:
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| 159
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| C 13837
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| S.C. Skolnikoff, Ph.D.
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| Vol #:
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| 159
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| C 13838
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| J. Smith
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| Vol #:
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| 159
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| 2005P-0509
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| Evaluation the warning to Consumers that Psychosis Is a possible adverse effect of Keppra (levetiracetam)
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| LET 1
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| FDA/CDER to Warren Rucker
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| Vol #:
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| 1
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| 2005V-0368
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| Projector for a Laser Light Show for Flare F1-1104; Flint: F2-0104; Firefly : F3-0905
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| VRA 1
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| FDA/CDRH to Prismatic Magic LLC
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| Vol #:
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| 1
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| 2006D-0254
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| Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2006D-0268
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| Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
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| C 1
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| R. Reinhard
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| Vol #:
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| 1
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| 2006N-0133
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Adver
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| C 3
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| AstraZeneca Pharmaceuticals, LP
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| Vol #:
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| 1
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| 2006P-0001
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| Date of Approval for Lunesta (Eszopiclone) 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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| 2006P-0047
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| Refrain from Approval any ANDA for Celestone Soluspan
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| PAV 1
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| FDA/CDER to SPEC Pharma
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| Vol #:
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| 1
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| 2006P-0241
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| Appeal District Court Civil Action No. 05-1838 (RWR) and deny the citzen petitions of Ivax and Ranbaxy
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| LET 1
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| FDA/CDER to Pollack PC
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| Vol #:
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| 1
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| 2006P-0258
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| Immediately approve ANDA No. 77-837 upon the June 23, 2006 patent expiration of U.S. Patent No. 4,444,784
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| LET 1
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| FDA/CDER to Pollack PC
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| Vol #:
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| 1
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| 2006V-0111
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| Projector for a Laser Light Show
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| VRA 1
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| FDA/CDRH to Aurora Projections
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| Vol #:
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| 1
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| 2006V-0153
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| Variance for Hair Removal System
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| VRA 2
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| FDA/CDRH to Palomar Medical Technologies, Inc.
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| Vol #:
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| 1
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| 2006V-0155
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| Laser Light Show
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| VRA 1
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| FDA/CDRH to Club Rabie, Inc
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| Vol #:
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| 1
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| 2006V-0248
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| Laser Light Show
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| VRA 1
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| FDA/CDRH to Independence High-SpaceScience Tech Magnet
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| Vol #:
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| 1
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