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| Dockets Entered
On January 12, 2006
Table of Contents
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| Docket #
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| Title
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| 1980N-0145B
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| Safety & Efficacy Review for OTC Ophthalmic Drug Prod.
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2000P-1466
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| Non-Approvable Letters for Neurontin
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| 2003E-0407
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| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
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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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| 2004P-0406
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| Distribution of Betamethasone Sodium Phosphate plus Betamethasone Acetate was withdrawn withdrawn for safety reasons
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| 2004P-0407
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| Withdrawn of Bethamethasone Sodium Phosphate was withdrawn for safety reasons
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma-Hydroxybutyric Acid; Ketamine;
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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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| 2006E-0022
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| Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| 2006E-0024
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| Patent Extension Application for VNS Therapy System, U.S. Patent No. 5,299,569
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| 2006E-0025
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| Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
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| 2006E-0026
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| U.S. Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
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| 2006M-0009
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| P020001 - STAN S31 Fetal Heart Monitor, Approved 11/1/05
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| 1980N-0145B
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| Safety & Efficacy Review for OTC Ophthalmic Drug Prod.
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| AP 1
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| Cornelia Damsky, Inc.
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| Vol #:
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| 1
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| C
76
Attachment
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| Australian Government
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| Vol #:
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| 2
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| C 77
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| C. Van
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| Vol #:
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| 2
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| 2000P-1466
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| Non-Approvable Letters for Neurontin
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| LET
2
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| STADA Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| M
1
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| HFD-600
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| Vol #:
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| 1
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| GDL
2
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| Guideline
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| Vol #:
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| 1
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| NAD
2
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| FDA
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| Vol #:
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| 1
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| 2003E-0407
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| Patent Term Restoration Application for Cypher, U.S. Patent No. 5,563,146
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| LET
3
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| HFD-5 to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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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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| LET
2
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| HFD-5 to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2004P-0406
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| | | | | | | | |
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| Distribution of Betamethasone Sodium Phosphate plus Betamethasone Acetate was withdrawn withdrawn for safety reasons
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2004P-0407
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| Withdrawn of Bethamethasone Sodium Phosphate was withdrawn for safety reasons
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2005N-0479
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| International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Butorphanol; Delta-9-tetrahydrocannabinol (Dronabinol); Gamma- Hydroxybutyric Acid; Ketamine;
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| C
1
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| Jazz Pharmaceuticals
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| Vol #:
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| 1
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| C
2
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| Pharmaceutical Research and Manfacturers of America (PhRMA)
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 255
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| M. Taylor
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| Vol #:
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| 3
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| C 256
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| T. Allison
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| Vol #:
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| 3
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| C 257
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| M. Gingles
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| Vol #:
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| 3
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| C 258
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| N. Franklin
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| Vol #:
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| 3
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| C 259
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| C. Maulden
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| Vol #:
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| 3
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| C 260
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| M. Burns
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| Vol #:
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| 3
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| C 261
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| M. Miller
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| Vol #:
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| 3
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| C 262
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| C. Rohde
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| Vol #:
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| 3
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| C 263
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| A. Thornton
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| Vol #:
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| 3
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| C 264
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| S. Niece
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| Vol #:
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| 3
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| C 265
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| J. Stoue
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| Vol #:
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| 3
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| C 266
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| J. Marler
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| Vol #:
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| 3
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| C 267
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| K. Sellars
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| Vol #:
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| 3
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| C 268
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| C. Ducre
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| Vol #:
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| 3
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| C 269
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| B. Shuffaln
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| Vol #:
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| 3
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| C 270
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| A. Miller
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| Vol #:
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| 3
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| 2006E-0022
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| Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411
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| APP
1
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| Amylin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| APP
1
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| Hidenori Okhi et al
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0024
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| Patent Extension Application for VNS Therapy System, U.S. Patent No. 5,299,569
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| APP
1
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| Cyberonics, Inc.
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| Vol #:
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| 1
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| | | | | | | | |
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| LET
1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0025
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| Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
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| APP
1
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| Genentech, Inc.
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0026
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| U.S. Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
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| APP
1
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| Genzyme Corporation
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| Vol #:
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| 1
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| LET
1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006M-0009
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| P020001 - STAN S31 Fetal Heart Monitor, Approved 11/1/05
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| AAV
1
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| Neoventa Medical AB
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| Vol #:
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| 1
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