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| Dockets Entered
On July 15, 2004
Table of Contents
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| Docket #
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| Title
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| 1998E-0488
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| Gonal-F (follitropin alpha/beta; U.S. Patent Ext # 5,156,957
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| 1998E-0852
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| Patent Extension # 5,298,520 MAXALT (rizatriptan Benzoate)
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| 1998E-1221
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| Celexa; Patent Term Extension Application,No.4,650,884
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|
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| 1999E-1086
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| Enbrel, Patent No. 5,712,155
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001E-0053
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| Patent Extension for Diphenylmethane diisocyanate, 4,968,514
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002E-0019
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| Patent Term Application for Axert No. 5,565,447
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| 2002E-0339
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| Benicar, U.S. Patent No. 5,616,599
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| 2003E-0033
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| Patent Extension Application for DERMAGRAFT No. 4,963,489
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| 2003E-0247
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| Patent Extension for Campath (Alemtuzumab), 5,545,403
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| 2004D-0160
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| Use of Unapproved Hormone Implants in Veal Calves
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| 2004E-0023
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| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
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| 2004E-0040
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| Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
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| 2004E-0307
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| Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
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| 2004E-0308
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| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
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| 2004E-0314
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| Patent Extension for Spiriva HandiHaler (tiotropium bromide inhalation powder), U.S. Patent No. 5,610,163
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| 2004E-0316
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| Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943
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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-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0279
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| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
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| 2004N-0291
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| Risk Assessment for Cosmetics and Potential Contamination with Bovine Spongiform Encephalopathy Agent
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| 2004P-0315
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| Switch Pseudoephedrine from Over the Counter (OTC) Sales
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| 2004P-0320
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| Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
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| 2004V-0317
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| Laser Light Show
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| 2004V-0318
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| Laser Light Show
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| ACK
5
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| HFA-305 to Dyclo9, Inc.
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| Vol #:
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| 70
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| CP
5
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| Dyclo9, Inc.
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| Vol #:
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| 70
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| 1998E-0488
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| Gonal-F (follitropin alpha/beta; U.S. Patent Ext # 5,156,957
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| LET
5
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| | | | | | | | |
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| 1998E-0852
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| Patent Extension # 5,298,520 MAXALT (rizatriptan Benzoate)
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| LET
4
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 1998E-1221
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| Celexa; Patent Term Extension Application,No.4,650,884
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| LET
4
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 1999E-1086
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| Enbrel, Patent No. 5,712,155
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| LET
3
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 292
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 293
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 294
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 295
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| EXB 296
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| Center for Veterinary Medicine
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| Vol #:
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| 420
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| 2001E-0053
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| Patent Extension for Diphenylmethane diisocyanate, 4,968,514
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|
|
| LET
5
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| U.S. Patent & Trademark Office
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| Vol #:
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| 1
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|
|
| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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|
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| EMC 7605
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| J. Manders
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| Vol #:
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| 280
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| EMC 7606
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| J. Haladay
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| Vol #:
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| 280
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| EMC 7607
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| J. Reid
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| Vol #:
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| 280
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| EMC 7608
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| A. Clifford
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| Vol #:
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| 280
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|
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| EMC 7609
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| C. Baker
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| Vol #:
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| 280
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|
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| EMC 7610
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| F. E. Murray
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| Vol #:
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| 280
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|
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| EMC 7611
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| J. S. Cornette
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| Vol #:
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| 280
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| EMC 7612
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| H. Hauserman
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| Vol #:
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| 280
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| EMC 7613
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| K. A. Walter
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| Vol #:
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| 280
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| EMC 7614
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| A. Bodenhemier
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| Vol #:
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| 280
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|
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| EMC 7615
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| C. Sommer
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| Vol #:
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| 280
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|
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| EMC 7616
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| H. Kent
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| Vol #:
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| 280
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| EMC 7617
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| E. Knapp
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| Vol #:
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| 280
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|
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| EMC 7618
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| C. Nussbaum
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| Vol #:
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| 280
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|
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| EMC 7619
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| C. M. Halsey
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| Vol #:
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| 280
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|
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| EMC 7620
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| E. Dubnoff
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| Vol #:
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| 280
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|
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| EMC 7621
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| K. McManus
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| Vol #:
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| 280
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|
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| EMC 7622
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| L. Morey
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| Vol #:
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| 280
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|
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| EMC 7623
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| M. Beaty
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| Vol #:
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| 280
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| EMC 7624
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| T. Meyer
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| Vol #:
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| 280
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| EMC 7625
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| K. Wrenn
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| Vol #:
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| 280
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| EMC 7626
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| C. M. Larson
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| Vol #:
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| 280
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|
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| EMC 7627
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| B. Morse
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| Vol #:
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| 280
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|
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| EMC 7628
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| J. Granger
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| Vol #:
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| 280
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|
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| EMC 7629
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| T. K. Wishart
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| Vol #:
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| 280
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|
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| EMC 7630
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| A. E. Lydon
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| Vol #:
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| 280
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|
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| EMC 7631
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| V. R. Durost
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| Vol #:
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| 280
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|
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| EMC 7632
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| D. Evans
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| Vol #:
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| 280
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|
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| EMC 7633
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| K. Maring
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| Vol #:
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| 280
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|
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| EMC 7634
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| J. Markowitz
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| Vol #:
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| 280
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|
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| EMC 7635
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| J. Bailey
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| Vol #:
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| 280
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| EMC 7636
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| K. McLennan
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| Vol #:
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| 280
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|
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| EMC 7637
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| C. Wessel
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| Vol #:
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| 280
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|
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| EMC 7638
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| G. R. Cullen
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| Vol #:
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| 280
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| EMC 7639
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| K. Sweitzer
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| Vol #:
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| 280
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| EMC 7640
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| K. E. Lovaas
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| Vol #:
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| 280
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|
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| EMC 7641
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| K. L. Crow
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| Vol #:
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| 280
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|
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| EMC 7642
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| J. Thacker
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| Vol #:
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| 280
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| EMC 7643
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| K. Bowsher
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| Vol #:
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| 280
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| EMC 7644
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| M. Shepard
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| Vol #:
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| 280
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| EMC 7645
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| H. Hirsch
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| Vol #:
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| 280
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| EMC 7646
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| N. Trainer
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| Vol #:
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| 280
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|
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| EMC 7647
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| D. Valentine
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| Vol #:
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| 280
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|
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| EMC 7648
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| J. Van Nostrand
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| Vol #:
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| 280
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| EMC 7649
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| B. Dunn
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| Vol #:
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| 280
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|
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| EMC 7650
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| B. Dunn
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| Vol #:
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| 280
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|
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| EMC 7651
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| Rev. L. R. Somers
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| Vol #:
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| 280
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| EMC 7652
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| A. L. Kirby
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| Vol #:
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| 280
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| EMC 7653
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| L. J. Gersicoff
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| Vol #:
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| 280
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|
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| EMC 7654
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| K. Lazor
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| Vol #:
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| 280
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|
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| EMC 7655
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| J. Callahan
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| Vol #:
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| 280
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|
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| EMC 7656
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| R. Stewart
|
| Vol #:
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| 280
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|
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| EMC 7657
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| L. K. Cassandra
|
| Vol #:
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| 280
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|
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| EMC 7658
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| L. S. Bailey
|
| Vol #:
|
| 280
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|
|
| EMC 7659
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| J. Goussot
|
| Vol #:
|
| 280
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|
|
| EMC 7660
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| D. F. Herden
|
| Vol #:
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| 280
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|
| | | | | | | |
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| EMC 7661
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| S. Barrett-Page
|
| Vol #:
|
| 280
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|
|
| EMC 7662
|
| M. VandenBerg
|
| Vol #:
|
| 280
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|
|
| EMC 7663
|
| J. Williamson
|
| Vol #:
|
| 280
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|
|
| EMC 7664
|
| L. P. McGuire
|
| Vol #:
|
| 280
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|
|
| EMC 7665
|
| M. Grim
|
| Vol #:
|
| 280
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|
|
| EMC 7666
|
| J. Troncao
|
| Vol #:
|
| 280
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|
|
| EMC 7667
|
| C. Catskill
|
| Vol #:
|
| 280
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|
|
| EMC 7668
|
| D. Burkhart
|
| Vol #:
|
| 280
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|
|
| EMC 7669
|
| H. L. Orn
|
| Vol #:
|
| 280
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|
|
| EMC 7670
|
| J. L. Hartshorn
|
| Vol #:
|
| 280
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|
|
| EMC 7671
|
| J. Reed
|
| Vol #:
|
| 280
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|
|
| EMC 7672
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| M. Halpern
|
| Vol #:
|
| 280
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|
|
| EMC 7673
|
| C. Clouse
|
| Vol #:
|
| 280
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|
|
| EMC 7674
|
| M. Samuel
|
| Vol #:
|
| 280
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|
|
| EMC 7675
|
| O. Robertson
|
| Vol #:
|
| 280
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|
|
| EMC 7676
|
| E. Johnson
|
| Vol #:
|
| 280
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|
|
| EMC 7677
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| L. Weinberg
|
| Vol #:
|
| 280
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|
|
| EMC 7678
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| J. Jackson Lusby
|
| Vol #:
|
| 280
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|
|
| EMC 7679
|
| J. Troyer
|
| Vol #:
|
| 280
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|
|
| EMC 7680
|
| A. Marshall
|
| Vol #:
|
| 280
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|
|
| EMC 7681
|
| V. Heller
|
| Vol #:
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| 280
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|
|
| EMC 7682
|
| K. Hanson
|
| Vol #:
|
| 280
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|
|
| EMC 7683
|
| L. S. Lerner
|
| Vol #:
|
| 280
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|
|
| EMC 7684
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| J. Morgan
|
| Vol #:
|
| 280
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|
|
| EMC 7685
|
| L. E. Dunnington
|
| Vol #:
|
| 280
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|
|
| EMC 7686
|
| H. Holliger
|
| Vol #:
|
| 280
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|
|
| EMC 7687
|
| Kathleen Cox
|
| Vol #:
|
| 280
|
|
|
| EMC 7688
|
| L. Doubleday
|
| Vol #:
|
| 280
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|
|
| EMC 7689
|
| s. Hottin
|
| Vol #:
|
| 280
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|
|
| EMC 7690
|
| C. Hartwell
|
| Vol #:
|
| 280
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|
|
| EMC 7691
|
| D. Williams
|
| Vol #:
|
| 280
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|
|
| EMC 7692
|
| M. A. Boyse
|
| Vol #:
|
| 280
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|
|
| EMC 7693
|
| H. Oliver
|
| Vol #:
|
| 280
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|
|
| EMC 7694
|
| M. Bailey
|
| Vol #:
|
| 280
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|
|
| EMC 7695
|
| D. Miller
|
| Vol #:
|
| 280
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|
|
| EMC 7696
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| K. Buchanan
|
| Vol #:
|
| 280
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|
|
| EMC 7697
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| J. Bonds
|
| Vol #:
|
| 280
|
|
| | | | | | | |
|
|
| EMC 7698
|
| M. Pike
|
| Vol #:
|
| 280
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|
|
| EMC 7699
|
| K. A. Spencer
|
| Vol #:
|
| 280
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|
|
| EMC 7700
|
| M. Saunders
|
| Vol #:
|
| 280
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|
|
| EMC 7701
|
| G. D. Gleckel
|
| Vol #:
|
| 280
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|
|
| EMC 7702
|
| L. Jenkins
|
| Vol #:
|
| 280
|
|
|
| EMC 7703
|
| L. Taylor
|
| Vol #:
|
| 280
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|
|
| EMC 7704
|
| A. F. Bezella
|
| Vol #:
|
| 280
|
|
|
| EMC 7705
|
| K. Walling
|
| Vol #:
|
| 280
|
|
|
| EMC 7706
|
| K. Rolfes
|
| Vol #:
|
| 280
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|
|
| EMC 7707
|
| L. Metcalf
|
| Vol #:
|
| 280
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|
|
| EMC 7708
|
| J. Mariette
|
| Vol #:
|
| 280
|
|
|
| EMC 7709
|
| J. L. S. Beck
|
| Vol #:
|
| 280
|
|
|
| EMC 7710
|
| K. Sergent
|
| Vol #:
|
| 280
|
|
|
| EMC 7711
|
| K. Fairchild
|
| Vol #:
|
| 280
|
|
|
| EMC 7712
|
| G. Morrow
|
| Vol #:
|
| 280
|
|
|
| EMC 7713
|
| J. Forman
|
| Vol #:
|
| 280
|
|
|
| EMC 7714
|
| M. Read
|
| Vol #:
|
| 280
|
|
|
| EMC 7715
|
| C. Lee Taylor
|
| Vol #:
|
| 280
|
|
|
| EMC 7716
|
| D. Solyan
|
| Vol #:
|
| 280
|
|
|
| EMC 7717
|
| A. Adams
|
| Vol #:
|
| 280
|
|
|
| EMC 7718
|
| M. Allekotte
|
| Vol #:
|
| 280
|
|
|
| EMC 7719
|
| A. Adams
|
| Vol #:
|
| 280
|
|
|
| EMC 7720
|
| R. Messano
|
| Vol #:
|
| 280
|
|
|
| EMC 7721
|
| R. A. Mendes
|
| Vol #:
|
| 280
|
|
|
| EMC 7722
|
| G. Potts
|
| Vol #:
|
| 280
|
|
|
| EMC 7723
|
| A. Riccone
|
| Vol #:
|
| 280
|
|
|
| EMC 7724
|
| V. LeBlanc
|
| Vol #:
|
| 280
|
|
|
| EMC 7725
|
| F. Campbell
|
| Vol #:
|
| 280
|
|
|
| EMC 7726
|
| J. E. Baldwin
|
| Vol #:
|
| 280
|
|
|
| EMC 7727
|
| C. Wright-Kaiser
|
| Vol #:
|
| 280
|
|
|
| EMC 7728
|
| M. Cantiello
|
| Vol #:
|
| 280
|
|
|
| EMC 7729
|
| M.M. Castro
|
| Vol #:
|
| 280
|
|
|
| EMC 7730
|
| E. Pleshe
|
| Vol #:
|
| 280
|
|
|
| EMC 7731
|
| J. Weinar
|
| Vol #:
|
| 280
|
|
|
| EMC 7732
|
| M. D. Hill
|
| Vol #:
|
| 280
|
|
|
| EMC 7733
|
| J. R. Moser
|
| Vol #:
|
| 280
|
|
|
| EMC 7734
|
| D. McNeill
|
| Vol #:
|
| 280
|
|
| | | | | | | |
|
|
| EMC 7735
|
| K. Markley
|
| Vol #:
|
| 280
|
|
|
| EMC 7736
|
| K. Nunez
|
| Vol #:
|
| 280
|
|
|
| EMC 7737
|
| N. R. Wright
|
| Vol #:
|
| 280
|
|
|
| EMC 7738
|
| S. L. Forsythe
|
| Vol #:
|
| 280
|
|
|
| EMC 7739
|
| M. M. Smozski
|
| Vol #:
|
| 280
|
|
|
| EMC 7740
|
| L. Raiteri
|
| Vol #:
|
| 280
|
|
|
| EMC 7741
|
| M. Britton
|
| Vol #:
|
| 280
|
|
|
| EMC 7742
|
| M. Ferguson
|
| Vol #:
|
| 280
|
|
|
| EMC 7743
|
| M. Rutherford
|
| Vol #:
|
| 280
|
|
|
| EMC 7744
|
| K. Stamm
|
| Vol #:
|
| 280
|
|
|
| EMC 7745
|
| A. M. Delinasiou
|
| Vol #:
|
| 280
|
|
|
| EMC 7746
|
| J. Forrester
|
| Vol #:
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| 280
|
|
|
| EMC 7747
|
| J. B. Sokolsky
|
| Vol #:
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| 280
|
|
|
| EMC 7748
|
| D. Takach
|
| Vol #:
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| 280
|
|
|
| EMC 7749
|
| KP
|
| Vol #:
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| 280
|
|
|
| EMC 7750
|
| E. Lyons
|
| Vol #:
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| 280
|
|
|
| EMC 7751
|
| K. Kirschling
|
| Vol #:
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| 280
|
|
|
| EMC 7752
|
| B. Dalhover
|
| Vol #:
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| 280
|
|
|
| EMC 7753
|
| L. Korin
|
| Vol #:
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| 280
|
|
|
| EMC 7754
|
| S. Bolikal
|
| Vol #:
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| 280
|
|
|
| EMC 7755
|
| L. Wagoner
|
| Vol #:
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| 280
|
|
|
| EMC 7756
|
| J. Lauzon
|
| Vol #:
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| 280
|
|
|
| EMC 7757
|
| j. M. Foss
|
| Vol #:
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| 280
|
|
|
| EMC 7758
|
| G. Perkins
|
| Vol #:
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| 280
|
|
|
| EMC 7759
|
| L. Prifogle
|
| Vol #:
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| 280
|
|
|
| EMC 7760
|
| P. Hval
|
| Vol #:
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| 280
|
|
|
| EMC 7761
|
| H. Nelson
|
| Vol #:
|
| 280
|
|
|
| EMC 7762
|
| M. Sneddon
|
| Vol #:
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| 280
|
|
|
| EMC 7763
|
| K. Schwarz
|
| Vol #:
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| 280
|
|
|
| EMC 7764
|
| L. Brunner
|
| Vol #:
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| 280
|
|
|
| EMC 7765
|
| C. Hart
|
| Vol #:
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| 280
|
|
|
| EMC 7766
|
| M. A. Mead
|
| Vol #:
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| 280
|
|
|
| EMC 7767
|
| J. Chandler
|
| Vol #:
|
| 280
|
|
|
| EMC 7768
|
| L. Sommer
|
| Vol #:
|
| 280
|
|
|
| EMC 7769
|
| N. Edwards
|
| Vol #:
|
| 280
|
|
|
| EMC 7770
|
| Dr. S. Cosgrove
|
| Vol #:
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| 280
|
|
|
| EMC 7771
|
| M. C. Atwood
|
| Vol #:
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| 280
|
|
| | | | | | | | |
|
|
| EMC 7772
|
| E. Bittel
|
| Vol #:
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| 280
|
|
|
| EMC 7773
|
| C. Montemayor
|
| Vol #:
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| 280
|
|
|
| EMC 7774
|
| A. Chisolm
|
| Vol #:
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| 280
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|
|
| EMC 7775
|
| I. Fosse
|
| Vol #:
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| 280
|
|
|
| EMC 7776
|
| C. Goddwin
|
| Vol #:
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| 280
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|
|
| EMC 7777
|
| R. W. Schultz
|
| Vol #:
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| 280
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|
|
| EMC 7778
|
| L. Robinson
|
| Vol #:
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| 280
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|
|
| 2002E-0019
|
| Patent Term Application for Axert No. 5,565,447
|
|
|
| LET
5
|
| U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
|
|
| 2002E-0339
|
| Benicar, U.S. Patent No. 5,616,599
|
|
|
| LET
5
|
| U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
|
|
| 2003E-0033
|
| Patent Extension Application for DERMAGRAFT No. 4,963,489
|
|
|
| LET
3
|
| U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
|
|
| 2003E-0247
|
| Patent Extension for Campath (Alemtuzumab), 5,545,403
|
|
|
| NEC
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004D-0160
|
| Use of Unapproved Hormone Implants in Veal Calves
|
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004E-0023
|
| Patent extension application 5,849,911 for Reyataz ( atazanavir sulfate )
|
|
|
| LET
3
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2004E-0040
|
| Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
|
|
|
| LET
3
|
| U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
|
|
| 2004E-0307
|
| Patent Extension for Altima (pemetrexed), U.S. Patent No. 5,344,932
|
|
|
| APP
1
Continued
|
| Eli Lilly and Company
|
| Vol #:
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| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2004E-0308
|
| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
|
|
|
| APP
1
|
| Q-MED AB
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2004E-0314
|
| Patent Extension for Spiriva HandiHaler (tiotropium bromide inhalation powder), U.S. Patent No. 5,610,163
|
|
|
| APP
1
|
| Boehringer Ingelheim KG
|
| Vol #:
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| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
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| 1
|
|
| | | | | | | | |
|
|
| 2004E-0316
|
| Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943
|
|
|
| APP
1
|
| Ferrer Internacional, S.A.
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2004E-0319
|
| Patent Extension for BEXTRA (valdecoxib), U.S. Patent No. 5,633,272
|
|
|
| APP
1
|
| Pharmacia Corporation of Pfizer Inc.
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
| BKG 1
|
| Background Information Refs 1-63
|
| Vol #:
|
| 2
|
|
|
| EA
1
|
| Environmental Assessment
|
| Vol #:
|
| 1
|
|
|
| FONS
1
|
| Finding of No Significant Impact
|
| Vol #:
|
| 1
|
|
|
| NIR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0257
|
| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
|
|
|
| BKG 1
|
| Background Material Refs 1-8
|
| Vol #:
|
| 1
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
| NAP
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0279
|
| Developing DIA/FDA Workshop: Pharmacogenomic Combination Product Co-development; Public Meeting
|
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004N-0291
|
| Risk Assessment for Cosmetics and Potential Contamination with Bovine Spongiform Encephalopathy Agent
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| RA
1
|
| Risk Assessment
|
| Vol #:
|
| 1
|
|
|
| 2004P-0315
|
| Switch Pseudoephedrine from Over the Counter (OTC) Sales
|
|
|
| ACK 1
|
| HFA-305 to Pharmacists Planning Service, Inc. (PPSI)
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| Pharmacists Planning Service, Inc. (PPSI)
|
| Vol #:
|
| 1
|
|
|
| 2004P-0320
|
| Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depakote (divalproex sodium delayed- release tablets)
|
|
|
| ACK
1
|
| HFA-305 to Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
| CP
1
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
| 2004V-0317
|
| Laser Light Show
|
|
|
| ACK 1
|
| HFA-305 to Caliente Resort LLC
|
| Vol #:
|
| 1
|
|
|
| VAR
1
|
| Caliente Resort LLC
|
| Vol #:
|
| 1
|
|
|
| 2004V-0318
|
| Laser Light Show
|
|
| | | | | | | |
|
|
| ACK 1
|
| HFA-305 to Sun on the Beach
|
| Vol #:
|
| 1
|
|
|
| VAR
1
|
| Sun on the Beach
|
| Vol #:
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| 1
|
|
|