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| Dockets Entered
On June 20, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2001E-0365
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| Patent Term Extension Application, NEXIUM 4,738,974
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| |
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| 2003E-0146
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| Patent Extension Application for RELPAX, No. 5,545,644
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| |
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| 2003E-0256
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| Patent Extension for Ranexa (ranolazine), 4,567,264
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| 2004E-0389
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| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
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| 2005E-0238
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| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
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| 2005E-0239
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| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
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| 2005E-0246
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| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
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| 2005E-0247
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| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
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| |
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| 2005E-0256
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| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
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| |
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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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| 2006D-0063
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| Draft Guidance for Industry and Food and Drug Administration; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program; Availability
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| 2006D-0228
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| Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
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| 2006E-0040
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| Patent Extension Application for ROZEREM (ramelteon), U.S. Patent No. 6,034,239
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| 2006E-0259
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| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
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| 2006P-0245
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| Exclusivity Determination for Risperidone
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| 2006P-0255
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| discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons
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| 2006P-0256
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| To permit a combination of parsol 1789 ( Avobenzone ) and zinc oxide and to allow the interim marketing of this combination in OTC sunscreen drug products
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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-0257
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| Laser Light Show
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| 1978N-0038
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| Sunscreen Drug Products
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| ACK 19
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| FDA/DDM to Schering-Plough Consumer Healthcare
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| Vol #:
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| 150
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| CP 18
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| Schering-Plough Consumer Healthcare
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| Vol #:
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| 150
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17915
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| Enzymatic Therapy
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| Vol #:
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| 165
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| LET 17916
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| Pro-Caps Laboratories
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| Vol #:
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| 165
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| LET 17917
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| Pro-Caps Laboratories
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| Vol #:
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| 165
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| LET 17918
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| Pro-Caps Laboratories
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| Vol #:
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| 165
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| LET 17919
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| Arkopharma, LLC
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| Vol #:
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| 165
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| |
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| LET 17920
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| DMD Pharmaceuticals
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| Vol #:
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| 165
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| |
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| LET 17921
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| DMD Pharmaceuticals
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| Vol #:
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| 165
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| |
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| LET 17922
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| Perrigo Company of South Carolina
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| Vol #:
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| 165
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| |
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| LET 17923
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| Perrigo Company of South Carolina
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| Vol #:
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| 165
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| LET 17924
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| Perrigo Company of South Carolina
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| Vol #:
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| 165
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|
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| LET 17925
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| Perrigo Company of South Carolina
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| Vol #:
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| 165
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| |
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| LET 17926
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| Perrigo Company of South Carolina
|
| Vol #:
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| 165
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| |
|
|
| LET 17927
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| Perrigo Company of South Carolina
|
| Vol #:
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| 165
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| |
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| LET 17928
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| Perrigo Company of South Carolina
|
| Vol #:
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| 165
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| |
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| LET 17929
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| NBTY Inc.
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| Vol #:
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| 165
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| |
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| LET 17930
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| NBTY Inc.
|
| Vol #:
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| 165
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| |
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| LET 17931
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| NBTY Inc.
|
| Vol #:
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| 165
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| |
|
|
| LET 17932
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| NBTY Inc.
|
| Vol #:
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| 165
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| |
|
|
| LET 17933
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| NBTY Inc.
|
| Vol #:
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| 165
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| |
|
|
| LET 17934
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| NBTY Inc.
|
| Vol #:
|
| 165
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| |
|
|
| LET 17935
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| NBTY Inc.
|
| Vol #:
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| 165
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| |
|
|
| LET 17936
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| NBTY Inc.
|
| Vol #:
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| 165
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|
|
| LET 17937
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| NBTY Inc.
|
| Vol #:
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| 165
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| |
|
|
| LET 17938
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| Natural Organics Inc.
|
| Vol #:
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| 165
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| |
|
|
| LET 17939
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| Hillestad Pharmaceuticals
|
| Vol #:
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| 165
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| LET 17940
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| Hillestad Pharmaceuticals
|
| Vol #:
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| 165
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| LET 17941
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| Hillestad Pharmaceuticals
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| Vol #:
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| 165
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| LET 17942
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| Sunrider International
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| Vol #:
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| 165
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| |
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| LET 17943
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| Sunrider International
|
| Vol #:
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| 165
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| |
|
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| LET 17944
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| Sunrider International
|
| Vol #:
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| 165
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| |
|
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| LET 17945
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| Sunrider International
|
| Vol #:
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| 165
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| |
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| LET 17946
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| Sunrider International
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| Vol #:
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| 165
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| LET 17947
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| Sunrider International
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| Vol #:
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| 165
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| |
|
|
| 2001E-0365
|
| Patent Term Extension Application, NEXIUM 4,738,974
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| |
|
|
| LET 5
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
|
| |
|
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| 2003E-0146
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| Patent Extension Application for RELPAX, No. 5,545,644
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| |
|
|
| LET 4
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| U.S. Patent and Trademark Office
|
| Vol #:
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| 1
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| |
|
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| 2003E-0256
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| Patent Extension for Ranexa (ranolazine), 4,567,264
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| |
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| LET 2
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| HFD-005 to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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|
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|
| 2004E-0389
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| Patent Extension for SURPASS (diclofenac sodium), U.S. Patent No. 4,937,078
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| |
|
|
| LET 4
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| U.S. Patent and Trademark Office
|
| Vol #:
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| 1
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|
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| 2005E-0238
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| Patent Extension Application for TYSABRI (natalizumab), U.S. Patent No. 5,840,299
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|
|
| LET 5
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005E-0239
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| Patent Extension Application for PRIALT (ziconotide), U.S. Patent No. 5,364,842
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|
|
| LET 5
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| U.S. Patent and Trademark Office
|
| Vol #:
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| 1
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| 2005E-0246
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| Patent Extension Appliation for PRIALT (ziconotide), U.S. Patent No. 5,795,864
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| |
|
|
| LET 5
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| U.S. Patent and Trademark Office
|
| Vol #:
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| 1
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| 2005E-0247
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| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
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|
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| LET 5
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| U.S. Patent and Trademark Office
|
| Vol #:
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| 1
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| 2005E-0256
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| Patent Extension Application for Ovidrel (choriogonadotropin alfa (recombinant human chorionic gonadotripin (r-HCG)), U.S. Patent No. 4,840,896
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| |
|
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| LET 5
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| U.S. Patent and Trademark Office
|
| Vol #:
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| 1
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|
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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 13330
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| Eligible
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| Vol #:
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| 155
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| C 13331
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| G. Eymard
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| Vol #:
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| 155
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| C 13332
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| K. Bergh
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| Vol #:
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| 155
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| C 13333
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| S. Micholson
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| Vol #:
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| 155
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| C 13334
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| S. Sanson
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| Vol #:
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| 155
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| C 13335
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| R. Watkins
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| Vol #:
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| 155
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| C 13336
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| L. Jones
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| Vol #:
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| 155
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| C 13337
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| L. Jones
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| Vol #:
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| 155
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| C 13338
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| S. Stovall
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| Vol #:
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| 155
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| C 13339
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| :. Onstad
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| Vol #:
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| 155
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| C 13340
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| J. Johnson
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| Vol #:
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| 155
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| C 13341
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| A. Hope, RN,BSN,MA.ED
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| Vol #:
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| 155
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| |
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| C 13342
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| L. Brigham
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| Vol #:
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| 155
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| C 13343
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| M. Meiselman
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| Vol #:
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| 155
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| |
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| C 13344
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| J. Siwek
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| Vol #:
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| 155
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| |
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| C 13345
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| F. Seals
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| Vol #:
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| 155
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| |
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| C 13346
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| M. Dayton
|
| Vol #:
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| 155
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| |
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| C 13347
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| M. Dayton
|
| Vol #:
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| 155
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| |
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| C 13348
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| C. Morrette
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| Vol #:
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| 155
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| |
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| C 13349
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| D. Johnson, DO
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| Vol #:
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| 155
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| |
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| C 13350
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| M. Meiselman
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| Vol #:
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| 155
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| |
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| C 13351
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| K. Johnson
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| Vol #:
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| 155
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| |
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| C 13352
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| H. Rubacky
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| Vol #:
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| 155
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| |
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| C 13353
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| C. Coleman
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| Vol #:
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| 155
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| |
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| C 13354
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| K. Mrljak
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| Vol #:
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| 155
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| | | | | | | |
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| |
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| C 13355
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| I. Mills
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| Vol #:
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| 155
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| |
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| C 13356
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| S. Gonzales
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| Vol #:
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| 155
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| |
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| C 13357
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| E. Tozloski
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| Vol #:
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| 155
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| |
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| C 13358
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| S. Clark
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| Vol #:
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| 155
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| |
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| C 13359
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| L. Boryer
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| Vol #:
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| 155
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| |
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| C 13360
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| J. Osten
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| Vol #:
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| 155
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| |
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| C 13361
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| J. Stewart
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| Vol #:
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| 155
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| C 13362
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| J. Aakhus
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| Vol #:
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| 155
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| |
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| C 13363
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| M. Rafferti
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| Vol #:
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| 155
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| |
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| C 13364
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| B. Miletich
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| Vol #:
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| 155
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| |
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| C 13365
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| C. Cooper
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| Vol #:
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| 155
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| |
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| C 13366
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| C. Wynn
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| Vol #:
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| 155
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| |
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| C 13367
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| C. Anthony
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| Vol #:
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| 155
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| |
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| C 13368
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| L. Metre
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| Vol #:
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| 155
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| |
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| C 13369
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| S. Michael
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| Vol #:
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| 155
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| |
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| C 13370
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| R. Cabrela
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| Vol #:
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| 155
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| |
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| C 13371
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| G. Wilson
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| Vol #:
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| 155
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| |
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| C 13372
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| J. Anderson
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| Vol #:
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| 155
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| |
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| C 13373
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| L. Eley
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| Vol #:
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| 155
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| |
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| C 13374
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| M. Scarazzo
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| Vol #:
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| 155
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| |
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| C 13375
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| J. Wyker
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| Vol #:
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| 155
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| |
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| C 13376
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| J. LaPeasunt
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| Vol #:
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| 155
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| |
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| C 13377
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| R. Gulley
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| Vol #:
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| 155
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| |
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| C 13378
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| M. Griffin
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| Vol #:
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| 155
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| |
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| C 13379
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| C. Kaczor, MD
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| Vol #:
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| 155
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| |
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| C 13380
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| J. Erickson
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| Vol #:
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| 155
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| |
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| C 13381
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| V. Wright
|
| Vol #:
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| 155
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| |
|
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| C 13382
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| R. Watson
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| Vol #:
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| 155
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| |
|
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| C 13383
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| L. Sutton
|
| Vol #:
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| 155
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| |
|
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| C 13384
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| M. Wood
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| Vol #:
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| 155
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| |
|
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| C 13385
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| R. John
|
| Vol #:
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| 155
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| |
|
|
| C 13386
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| M. Bain
|
| Vol #:
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| 155
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| |
|
|
| C 13387
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| R. Ehrenberg
|
| Vol #:
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| 155
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| |
|
|
| C 13388
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| L. Schall
|
| Vol #:
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| 155
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| |
|
|
| C 13389
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| L. Sutton
|
| Vol #:
|
| 155
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| |
|
|
| C 13390
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| E. Kennedy
|
| Vol #:
|
| 155
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| |
|
|
| C 13391
|
| W. Emery
|
| Vol #:
|
| 155
|
|
| | | | | | | |
|
| |
|
| C 13392
|
| K. Collins
|
| Vol #:
|
| 155
|
| |
|
|
| C 13393
|
| C. Miller
|
| Vol #:
|
| 155
|
| |
|
|
| C 13394
|
| S. Korzeniowski
|
| Vol #:
|
| 155
|
| |
|
|
| C 13395
|
| D. Karn
|
| Vol #:
|
| 155
|
| |
|
|
| C 13396
|
| D.Hubbell
|
| Vol #:
|
| 155
|
| |
|
|
| C 13397
|
| M. Cortese
|
| Vol #:
|
| 155
|
| |
|
|
| C 13398
|
| D. Krall
|
| Vol #:
|
| 155
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| |
|
|
| C 13399
|
| R. Fox
|
| Vol #:
|
| 155
|
| |
|
|
| C 13400
|
| J. Welch
|
| Vol #:
|
| 155
|
| |
|
|
| C 13401
|
| J. Strader
|
| Vol #:
|
| 155
|
| |
|
|
| C 13402
|
| Eligible
|
| Vol #:
|
| 155
|
| |
|
|
| C 13403
|
| E. Farran
|
| Vol #:
|
| 155
|
| |
|
|
| C 13404
|
| J. Stern
|
| Vol #:
|
| 155
|
| |
|
|
| C 13405
|
| A. Woodward
|
| Vol #:
|
| 155
|
| |
|
|
| C 13406
|
| D. Davis
|
| Vol #:
|
| 155
|
| |
|
|
| C 13407
|
| P. Meyer
|
| Vol #:
|
| 155
|
| |
|
|
| C 13408
|
| C. Lehman
|
| Vol #:
|
| 155
|
| |
|
|
| C 13409
|
| D. Hudgins
|
| Vol #:
|
| 155
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| |
|
|
| C 13410
|
| D. Davis
|
| Vol #:
|
| 155
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| |
|
|
| C 13411
|
| R. Kombosch
|
| Vol #:
|
| 155
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| |
|
|
| C 13412
|
| K. Hall
|
| Vol #:
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| 155
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| |
|
|
| C 13413
|
| M. Levenstein
|
| Vol #:
|
| 155
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| |
|
|
| C 13414
|
| B. O'Connor
|
| Vol #:
|
| 155
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| |
|
|
| C 13415
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| L. Watts
|
| Vol #:
|
| 155
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| |
|
|
| C 13416
|
| S. KEssler
|
| Vol #:
|
| 155
|
| |
|
|
| C 13417
|
| L. DeRanieu
|
| Vol #:
|
| 155
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| |
|
|
| C 13418
|
| N. Rude
|
| Vol #:
|
| 155
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| |
|
|
| C 13419
|
| J. Salomon
|
| Vol #:
|
| 155
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| |
|
|
| C 13420
|
| J. Gagnon
|
| Vol #:
|
| 155
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| |
|
|
| C 13421
|
| D. Gagnon
|
| Vol #:
|
| 155
|
| |
|
|
| C 13422
|
| S. Murphy
|
| Vol #:
|
| 155
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| |
|
|
| C 13423
|
| J. Gagnon
|
| Vol #:
|
| 155
|
| |
|
|
| C 13424
|
| D. Gagnon
|
| Vol #:
|
| 155
|
| |
|
|
| C 13425
|
| J. Miller
|
| Vol #:
|
| 155
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| |
|
|
| C 13426
|
| J. Salomon
|
| Vol #:
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| 155
|
| |
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|
| C 13427
|
| E. Egge
|
| Vol #:
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| 155
|
| |
|
|
| C 13428
|
| S. Sharpe
|
| Vol #:
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| 155
|
|
| | | | | | | |
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| |
|
| C 13429
|
| H. Kling
|
| Vol #:
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| 155
|
| |
|
|
| C 13430
|
| S. Murphy
|
| Vol #:
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| 155
|
| |
|
|
| C 13431
|
| L. Patton
|
| Vol #:
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| 155
|
| |
|
|
| C 13432
|
| S. Williams
|
| Vol #:
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| 155
|
| |
|
|
| C 13433
|
| S. Murphy
|
| Vol #:
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| 155
|
| |
|
|
| C 13434
|
| S. Morris
|
| Vol #:
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| 155
|
| |
|
|
| C 13435
|
| M. Beathe
|
| Vol #:
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| 155
|
| |
|
|
| C 13436
|
| B. Lodolo
|
| Vol #:
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| 155
|
| |
|
|
| C 13437
|
| R. Hildebrand
|
| Vol #:
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| 155
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| |
|
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| C 13438
|
| H. Reeder
|
| Vol #:
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| 155
|
| |
|
|
| C 13439
|
| K. Unicum
|
| Vol #:
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| 155
|
| |
|
|
| C 13440
|
| A. Reeder
|
| Vol #:
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| 155
|
| |
|
|
| C 13441
|
| S. Breen
|
| Vol #:
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| 155
|
| |
|
|
| C 13442
|
| C. Capelli
|
| Vol #:
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| 155
|
| |
|
|
| C 13443
|
| J. Taylor
|
| Vol #:
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| 155
|
| |
|
|
| C 13444
|
| K. French
|
| Vol #:
|
| 155
|
| |
|
|
| C 13445
|
| S. McCune
|
| Vol #:
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| 155
|
| |
|
|
| C 13446
|
| M. Hoffert
|
| Vol #:
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| 155
|
| |
|
|
| C 13447
|
| R. Talbot
|
| Vol #:
|
| 155
|
| |
|
|
| C 13448
|
| N. Carper
|
| Vol #:
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| 155
|
| |
|
|
| C 13449
|
| P. Schultz
|
| Vol #:
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| 155
|
| |
|
|
| C 13450
|
| C. Garnin
|
| Vol #:
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| 155
|
| |
|
|
| C 13451
|
| T. Silvers
|
| Vol #:
|
| 155
|
| |
|
|
| C 13452
|
| L. Miller
|
| Vol #:
|
| 155
|
| |
|
|
| C 13453
|
| V. Hemphill
|
| Vol #:
|
| 155
|
| |
|
|
| C 13454
|
| K. Cole
|
| Vol #:
|
| 155
|
| |
|
|
| C 13455
|
| T. Miller
|
| Vol #:
|
| 155
|
| |
|
|
| C 13456
|
| H. Risard
|
| Vol #:
|
| 155
|
| |
|
|
| C 13457
|
| D. Priest
|
| Vol #:
|
| 155
|
| |
|
|
| C 13458
|
| S. Toyama
|
| Vol #:
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| 155
|
| |
|
|
| C 13459
|
| Y. Springsteen
|
| Vol #:
|
| 155
|
| |
|
|
| C 13460
|
| B. Higa
|
| Vol #:
|
| 155
|
| |
|
|
| C 13461
|
| K. McCahill
|
| Vol #:
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| 155
|
| |
|
|
| C 13462
|
| J. Rarick
|
| Vol #:
|
| 155
|
| |
|
|
| C 13463
|
| G. Spencer
|
| Vol #:
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| 155
|
| |
|
|
| C 13464
|
| K. Robinson
|
| Vol #:
|
| 155
|
| |
|
|
| C 13465
|
| M. Tingy
|
| Vol #:
|
| 155
|
|
| | | | | | | | |
|
| |
|
| C 13466
|
| C. Guigin
|
| Vol #:
|
| 155
|
| |
|
|
| C 13467
|
| R. Connett
|
| Vol #:
|
| 155
|
| |
|
|
| C 13468
|
| L. Connett
|
| Vol #:
|
| 155
|
| |
|
|
| C 13469
|
| M. Davenport
|
| Vol #:
|
| 155
|
| |
|
|
| C 13470
|
| M. Elieff
|
| Vol #:
|
| 155
|
| |
|
|
| C 13471
|
| L. Salandro
|
| Vol #:
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| 155
|
| |
|
|
| C 13472
|
| P. Gilford
|
| Vol #:
|
| 155
|
| |
|
|
| C 13473
|
| M. Waters
|
| Vol #:
|
| 155
|
| |
|
|
| C 13474
|
| K. Smith
|
| Vol #:
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| 155
|
| |
|
|
| C 13475
|
| L. Gruver
|
| Vol #:
|
| 155
|
| |
|
|
| C 13476
|
| M. Scherer
|
| Vol #:
|
| 155
|
| |
|
|
| C 13477
|
| K. Braun
|
| Vol #:
|
| 155
|
| |
|
|
| C 13478
|
| K. Maher
|
| Vol #:
|
| 155
|
| |
|
|
| C 13479
|
| S. Baxter
|
| Vol #:
|
| 155
|
| |
|
|
| C 13480
|
| A. Hanley
|
| Vol #:
|
| 155
|
| |
|
|
| C 13481
|
| C. Weides
|
| Vol #:
|
| 155
|
| |
|
|
| C 13482
|
| L. Files
|
| Vol #:
|
| 155
|
| |
|
|
| C 13483
|
| P. Trulen
|
| Vol #:
|
| 155
|
| |
|
|
| C 13484
|
| T. Eailey
|
| Vol #:
|
| 155
|
| |
|
|
| C 13485
|
| S. Compton
|
| Vol #:
|
| 155
|
| |
|
|
| C 13486
|
| S. Amodt
|
| Vol #:
|
| 155
|
| |
|
|
| C 13487
|
| P. Peplow
|
| Vol #:
|
| 155
|
| |
|
|
| C 13488
|
| Eligible
|
| Vol #:
|
| 155
|
| |
|
|
| 2006D-0063
|
| Draft Guidance for Industry and Food and Drug Administration; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program; Availability
|
|
|
|
|
|
|
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0228
|
| Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
|
| |
|
|
| GDL 1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0040
|
| Patent Extension Application for ROZEREM (ramelteon), U.S. Patent No. 6,034,239
|
| |
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0259
|
| Patent Extension Application for X-STOP Interspinous Process Decompression System, U.S. Patent No. 6,235,030
|
|
|
| APP 1
|
| St. Francis Medical Technologies, Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| LET 1
|
| U.S. Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0245
|
| Exclusivity Determination for Risperidone
|
| |
|
|
| CR 1
|
| FDA/DDM to Mylan Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0255
|
| discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons
|
| |
|
|
| ACK 1
|
| HFA-305 to Orchid Healthcare
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Orchid Healthcare (A Division of Orchid Chemicals & Pharmaceuticals Ltd)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0256
|
| To permit a combination of parsol 1789 ( Avobenzone ) and zinc oxide and to allow the interim marketing of this combination in OTC sunscreen drug products
|
| |
|
|
| ACK 1
|
| Number Not Used
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Number Not Used
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0258
|
| Immediately approve ANDA No. 77-837 upon the June 23, 2006 patent expiration of U.S. Patent No. 4,444,784
|
| |
|
|
| ACK 1
|
| FDA-DDM to Zydus Pharmaceuticals (USA) Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| Zydus Pharmaceuticals (USA) Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006V-0257
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| FDA/ DDM to Bart Rocket Theatre
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| Bart Rocket Theatre
|
| Vol #:
|
| 1
|
|
|
