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Dockets Management
Dockets Entered On February 16, 2007
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2003N-0355 Medical Devices; Exception from General Requirements for Informed Consent
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006E-0236 Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
2006N-0274 Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile
2006N-0435 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes
2007N-0050 Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 18602 PuraPharm Corporation Vol #: 169
LET 18603 PuraPharm Corporation Vol #: 169
LET 18604 PuraPharm Corporation Vol #: 169
LET 18605 PuraPharm Corporation Vol #: 169
LET 18606 PuraPharm Corporation Vol #: 169
LET 18607 PuraPharm Corporation Vol #: 169
LET 18608 PuraPharm Corporation Vol #: 169
LET 18609 PuraPharm Corporation Vol #: 169
LET 18610 PuraPharm Corporation Vol #: 169
LET 18611 PuraPharm Corporation Vol #: 169
LET 18612 PuraPharm Corporation Vol #: 169
LET 18613 PuraPharm Corporation Vol #: 169
LET 18614 PuraPharm Corporation Vol #: 169
LET 18615 PuraPharm Corporation Vol #: 169
LET 18616 PuraPharm Corporation Vol #: 169
LET 18617 PuraPharm Corporation Vol #: 169
LET 18618 PuraPharm Corporation Vol #: 169
LET 18619 PuraPharm Corporation Vol #: 169
LET 18620 PuraPharm Corporation Vol #: 169
LET 18621 PuraPharm Corporation Vol #: 169
LET 18622 PuraPharm Corporation Vol #: 169
LET 18623 PuraPharm Corporation Vol #: 169
LET 18624 PuraPharm Corporation Vol #: 169
LET 18625 PuraPharm Corporation Vol #: 169
LET 18626 PuraPharm Corporation Vol #: 169
LET 18627 PuraPharm Corporation Vol #: 169
LET 18628 PuraPharm Corporation Vol #: 169
LET 18629 PuraPharm Corporation Vol #: 169
LET 18630 PuraPharm Corporation Vol #: 169
LET 18631 PuraPharm Corporation Vol #: 169
LET 18632 PuraPharm Corporation Vol #: 169
LET 18633 PuraPharm Corporation Vol #: 169
LET 18634 PuraPharm Corporation Vol #: 169
LET 18635 PuraPharm Corporation Vol #: 169
LET 18636 PuraPharm Corporation Vol #: 169
LET 18637 PuraPharm Corporation Vol #: 169
LET 18638 PuraPharm Corporation Vol #: 169
LET 18639 PuraPharm Corporation Vol #: 169
LET 18640 PuraPharm Corporation Vol #: 169
LET 18641 PuraPharm Corporation Vol #: 169
LET 18642 PuraPharm Corporation Vol #: 169
LET 18643 NewMark: A Division of New Chapter. Vol #: 169
LET 18644 NewMark: A Division of New Chapter. Vol #: 169
LET 18645 NewMark: A Division of New Chapter. Vol #: 169
LET 18646 NewMark: A Division of New Chapter. Vol #: 169
LET 18647 NewMark: A Division of New Chapter. Vol #: 169
LET 18648 NewMark: A Division of New Chapter. Vol #: 169
LET 18649 NewMark: A Division of New Chapter. Vol #: 169
LET 18650 NewMark: A Division of New Chapter. Vol #: 169
LET 18651 NewMark: A Division of New Chapter. Vol #: 169
LET 18652 NewMark: A Division of New Chapter. Vol #: 169
LET 18653 NewMark: A Division of New Chapter. Vol #: 169
LET 18654 Botanical Laboratories, Inc. Vol #: 169
LET 18655 Botanical Laboratories, Inc. Vol #: 169
LET 18656 Botanical Laboratories, Inc. Vol #: 169
LET 18657 Botanical Laboratories, Inc. Vol #: 169
LET 18658 NBTY Inc. Vol #: 169
LET 18659 Perrigo Company of South Carolina Vol #: 169
LET 18660 Perrigo Company of South Carolina Vol #: 169
LET 18661 Perrigo Company of South Carolina Vol #: 169
LET 18662 Perrigo Company of South Carolina Vol #: 169
LET 18663 Perrigo Company of South Carolina Vol #: 169
LET 18664 Perrigo Company of South Carolina Vol #: 169
LET 18665 Perrigo Company of South Carolina Vol #: 169
LET 18666 Perrigo Company of South Carolina Vol #: 169
LET 18667 NBTY Inc. Vol #: 169
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 2098 G. Roeder Vol #: 348
C 2099 L. Gray Vol #: 348
C 2100 D. and P. Begnier Vol #: 348
C 2101 D. and P. Begnier Vol #: 348
C 2102 H. Rupert Vol #: 348
C 2103 C. Hensen Vol #: 348
C 2104 P. Horn Vol #: 348
C 2105 D. Lindstrom Vol #: 348
C 2106 D.and P. Conklin Vol #: 348
C 2107 L. Pelo Vol #: 348
C 2108 P. Hower Vol #: 348
C 2109 L. Lindstrom Vol #: 348
C 2110 Mr. & Mrs. M. Kevany Vol #: 348
C 2111 M. Norton Vol #: 348
C 2112 G. Morris Vol #: 348
2003N-0355 Medical Devices; Exception from General Requirements for Informed Consent
N 1 FDA Vol #: 1
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
FF 1 TMJ Implants, Inc. Vol #: 241
FF 2 FDA/CDRH/OGC Vol #: 240
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
C 33 M. Giese Vol #: 7
C 34 M. Hayes Vol #: 7
C 35 C. Krul Vol #: 7
C 36 D. Fitzhugh Vol #: 7
C 37 S. O'Connor Vol #: 7
C 38 C. Marchese Vol #: 7
C 39 D. Hart Vol #: 7
C 40 W. Hollis Vol #: 7
C 41 S. Maddison Vol #: 7
C 42 W. Raymond Vol #: 7
C 43 K. Thinel Vol #: 7
C 44 M. Fisher-Kern Vol #: 7
C 45 S. Salzano Vol #: 7
C 46 T. Winbush Vol #: 7
C 47 C. Vallone Vol #: 7
C 48 K. Ailer Vol #: 7
C 49 V. Mchreleaus Vol #: 7
C 50 C. Pendergrass Vol #: 7
C 51 P. Filipski Vol #: 7
C 52 B. Callahan Vol #: 7
C 53 B. Tuteiu Vol #: 7
C 54 J. Sects Vol #: 7
C 55 D. Scholl Vol #: 7
C 56 D. Brown Vol #: 7
C 57 S. Fox Vol #: 7
C 58 K. Masters Vol #: 7
C 59 A. Shea Vol #: 7
C 60 N. Fox Vol #: 7
C 61 L. Draschil Vol #: 7
C 62 A. Gebb Vol #: 7
C 63 T. Burseth Vol #: 7
C 64 P. Ryan Vol #: 7
C 65 C. Parrish Vol #: 7
C 66 J. Pikelis Vol #: 7
C 67 J. Christian Vol #: 7
C 68 S. Reynolds Vol #: 7
C 69 R. Tremblay-Costello Vol #: 7
C 70 S. Fournier Vol #: 7
C 71 M. Chowen Vol #: 7
C 72 K. Beth Hummelberg Vol #: 7
C 73 E. Murphy Vol #: 7
C 74 C. Strauss Vol #: 7
C 75 S. Rockstad Vol #: 7
C 76 E. Patula Vol #: 7
C 77 B. Roman Vol #: 7
C 78 A. Rinaldi Vol #: 7
C 79 K. Hatch Vol #: 7
C 80 D. D'Amico Vol #: 7
C 81 no signature Vol #: 7
C 82 M. Chawus Vol #: 7
C 83 E. Simon Vol #: 7
C 84 I. Kim Vol #: 7
C 85 M. Medina Vol #: 7
C 86 A. Eisenberg Vol #: 7
C 87 T. Randall Vol #: 7
C 88 M. Smith Vol #: 7
C 89 P. Pendergrass Vol #: 7
C 90 J. Coyle Vol #: 7
C 91 E. Ondick Vol #: 7
C 92 M. Ayers Vol #: 7
C 93 E. Hopkins Vol #: 7
C 94 E. Schiff Vol #: 7
C 95 G. Manzoni Vol #: 7
C 96 K. Alter Vol #: 7
C 97 S. Philly Vol #: 7
C 98 P. Ferrell Vol #: 7
C 99 J. Laing Vol #: 7
C 100 I. Gordon Vol #: 7
C 101 S. Howe Vol #: 7
C 102 P. Tregenza Vol #: 7
C 103 H. Amorgan Vol #: 7
C 104 B. Carlsen Vol #: 7
C 105 A. Landenig Vol #: 7
C 106 E. Woolever Vol #: 7
C 107 G. Lone Vol #: 7
C 108 A. Sturm Vol #: 7
C 109 L. Bodiford Vol #: 7
C 110 C. Dietzel Vol #: 7
C 111 F. Cone Vol #: 7
C 112 G. Hernandez Vol #: 7
C 113 M. Sunder Vol #: 7
C 114 M. Ayars Vol #: 7
C 115 A. Goodman Vol #: 7
C 116 R. Bateman Vol #: 7
C 117 W. Grate Vol #: 7
C 118 L. Roach Vol #: 7
C 119 J. Hughes Vol #: 7
C 120 P. Lillis Vol #: 7
C 121 J. Lajeunasse Vol #: 7
C 122 A. Flincher Vol #: 7
C 123 C. Evans Vol #: 7
C 124 E. Killough Vol #: 7
C 125 K. Hellman Vol #: 7
C 126 M. Lee Vol #: 7
C 127 C.Maria Vol #: 7
C 128 P. Bird Vol #: 7
C 129 L. Zucker Vol #: 7
C 130 F. Cone Vol #: 7
C 131 E. Murphy Vol #: 7
C 132 S. Sargent Vol #: 7
C 133 M> Sikes Vol #: 7
C 134 L. Sherwood Vol #: 7
C 135 M. Cuff Vol #: 7
C 136 K. Cahill-Heiss Vol #: 7
C 137 S. Krasnansky Vol #: 7
C 138 D. Schneider Vol #: 7
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18254 C. Bozell Vol #: 198
C 18255 L. Brannon Vol #: 198
C 18256 J. Kerr Vol #: 198
2006E-0236 Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,494,903
N 1 FDA Vol #: 1
2006N-0274 Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2006N-0435 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes
N 2 FDA Vol #: 1
2007N-0050 Agency Information Collection Activities; Proposed Collection; Comment Request; Label Comprehension Study
N 1 FDA Vol #: 1

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