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Dockets Management

Dockets Entered On January 18, 2007
Docket # Title
1986V-0315 Ion laser technology series ILT 5000 Demo unit
2003N-0573 Draft Animal Cloning Risk Assessment
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2005P-0496 ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
2005V-0009 Projector for a Laser Light Show
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
2006D-0514 Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
2006P-0007 Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
2006P-0173 Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
2006P-0285 Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale
2006P-0287 determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
2006P-0311 Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2006P-0442 Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
2006P-0487 Health Claim Petition: Isomaltulose and Dental Caries
2007P-0028 Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons
1986V-0315 Ion laser technology series ILT 5000 Demo unit
EXP 4 California Technical Associates dba CTA Systems Vol #: 1
2003N-0573 Draft Animal Cloning Risk Assessment
C 56 No signature Vol #: 9
C 57 Illigible Vol #: 9
C 58 R. Muncrief Vol #: 9
C 59 B. Briswell Vol #: 9
C 60 M. Crotty Vol #: 9
C 61 J. Coryea Vol #: 9
C 62 J and S May Vol #: 9
C 63 A. Casanova Vol #: 9
C 64 B. Merryweather Vol #: 9
C 65 E. Levin Vol #: 9
C 66 S. Younger Vol #: 9
C 67 E. Schailile Vol #: 9
C 68 G. Weining Vol #: 9
C 69 No signature Vol #: 9
C 70 A. Skowronek Vol #: 9
C 71 G. Roth Vol #: 9
C 72 H. Vessell Vol #: 9
C 73 J. Whitehead Vol #: 9
C 74 B. Seely Vol #: 9
C 75 H. Weatherford Vol #: 9
C 76 V. Bequette Vol #: 9
C 77 S. Waters Vol #: 9
C 78 S. Waters Vol #: 9
C 79 S. Waters Vol #: 9
C 80 J. Hairston Vol #: 9
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
C 15 Children's Memorial Hospital Vol #: 3
C 16 Florida Center for Cellular Therapy Vol #: 3
C 17 E. Agura, M.D. Vol #: 3
C 18 University of Florida Vol #: 3
C 19 Stanford University Vol #: 3
C 20 Duke University Medical Center Vol #: 3
C 21 HollisterStier Laboratories, LLC Vol #: 3
C 22 Allergy Laboratories, Inc. Vol #: 3
2005P-0496 ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
PAV 1 FDA/CDER to Mayne Pharma (USA) Inc. Vol #: 2
2005V-0009 Projector for a Laser Light Show
EXP 1 Laser Show Parties Vol #: 1
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
C 1084 R. Hopklins Vol #: 40
C 1085 T. McCourt Vol #: 40
C 1086 J and M Miller Vol #: 40
C 1087 R. Shay Vol #: 40
C 1088 N. LaGuda Vol #: 40
C 1089 B. Dolph Vol #: 40
C 1090 J. Jalbert Vol #: 40
C 1091 F and K Riedel Vol #: 40
C 1092 J. Sherman Vol #: 40
C 1093 J. Casey Vol #: 40
C 1094 M. Callahan Vol #: 40
C 1095 M and M Sabine Vol #: 40
C 1096 M and T Kachris Vol #: 40
C 1097 Dr. T. Hogan Vol #: 40
C 1098 J. Lairs Vol #: 40
C 1099 P. Henry Vol #: 40
C 1100 J Klein et al. Vol #: 40
C 1101 J and C Ely Vol #: 40
C 1102 C. Tonkinson Vol #: 40
C 1103 J. Ellingson Vol #: 40
C 1104 I. Tedesco et al Vol #: 40
C 1105 G. McDonald Vol #: 40
C 1106 K. Porter Vol #: 41
C 1107 S. Pawelski Vol #: 41
C 1108 J. Cizek Vol #: 41
C 1109 D. Brown Vol #: 41
C 1110 M and S Allard Vol #: 41
C 1111 C. Brown Vol #: 41
C 1112 A. Ostrowski Vol #: 41
C 1113 J. Hitzelberger Vol #: 41
C 1114 A. Bizub Vol #: 41
C 1115 J. Epkey Vol #: 41
C 1116 J. Farmer Vol #: 41
C 1117 J. Fields Vol #: 41
C 1118 J. Fiacco Vol #: 41
C 1119 G. Lallement Vol #: 41
C 1120 D. Schuster Vol #: 41
C 1121 M and D Ernst Vol #: 41
C 1122 J. Guillette Vol #: 41
C 1123 J and M Miller Vol #: 41
C 1124 F. Seiker Vol #: 41
C 1125 D. Keefe, S.J., J.D., S.T.D. Vol #: 41
C 1126 D. Paige Vol #: 41
C 1127 J. McDonsoy Vol #: 41
C 1128 K. Steger Vol #: 41
C 1129 L. Ruff Vol #: 41
C 1130 B. Nicholson Vol #: 41
C 1131 L. Clarke Vol #: 41
C 1132 J. Hrbain Vol #: 41
C 1133 J. Lukasik Vol #: 41
C 1134 4 signatures Vol #: 41
C 1135 M. Spicer Vol #: 41
C 1136 B. Sherman Vol #: 41
C 1137 J. Jahn Vol #: 41
C 1138 B. Ehlers Vol #: 41
C 1139 D. Bailey Vol #: 41
C 1140 P. Nullin Vol #: 41
C 1141 F. Williamson Vol #: 41
C 1142 Dr. A. Wheeler Vol #: 41
C 1143 R. Couri Vol #: 41
C 1144 J. Pelc Vol #: 41
C 1145 M. Carpenter Vol #: 41
C 1146 M. Pototschick Vol #: 41
C 1147 S. Holmes, LPN Vol #: 41
C 1148 M. Bowman Vol #: 41
C 1149 P. Chapello Vol #: 41
C 1150 C and L Aumen Vol #: 41
C 1151 E. Hruska Vol #: 41
C 1152 J. Sielle Vol #: 41
C 1153 R. Phillips Vol #: 41
C 1154 M. Tirpak Vol #: 41
C 1155 A and W Heinen Vol #: 41
C 1156 C. Hecke Vol #: 41
C 1157 R. Nelson Vol #: 41
C 1158 T. Koch Vol #: 41
C 1159 K. Foltz Vol #: 41
C 1160 T. McCourt Vol #: 41
C 1161 E. Kunz et al Vol #: 41
C 1162 J. Neumann Vol #: 41
C 1163 G and M Loegering Vol #: 41
C 1164 P. Derr Vol #: 41
C 1165 S. Schutte Vol #: 41
C 1166 K. Pecha Vol #: 41
C 1167 J and T Tabel Vol #: 41
C 1168 B. Berg Vol #: 41
C 1169 L. Lytell Vol #: 41
C 1170 M. Mitchell Vol #: 41
C 1171 R. Orbeck Vol #: 41
C 1172 M. Scherber Vol #: 41
C 1173 J. LaLonde Vol #: 41
C 1174 A. Hutt Vol #: 41
C 1175 M. Atchison Vol #: 41
C 1176 M. Wurmnest Vol #: 41
C 1177 J. Mulcahy Vol #: 41
C 1178 B. Ward Vol #: 41
C 1179 K. Smith Vol #: 41
C 1180 P and L Rausch Vol #: 41
C 1181 H. Krueger, Jr. Vol #: 41
C 1182 D. Porfiri Vol #: 41
C 1183 M. Province Vol #: 41
C 1184 D. Fox Vol #: 41
C 1185 J. Fox Vol #: 41
C 1186 J. Rice Vol #: 41
C 1187 A. Glaser Vol #: 41
C 1188 407 signatures Vol #: 41
C 1189 M. Hutchinson Vol #: 41
C 1190 J and C Ely Vol #: 41
C 1191 M and P Tasin Vol #: 41
C 1192 M. Callahan Vol #: 41
C 1193 M. and M. Sabine Vol #: 41
C 1194 M. Hogan Vol #: 41
C 1195 D. Schuster Vol #: 41
C 1196 M. Tirpak Vol #: 41
C 1197 P. Zeller Vol #: 41
C 1198 C. Leon Vol #: 41
C 1199 Nevada Care Medical Center Vol #: 41
C 1200 J. Farmer Vol #: 41
C 1201 J. Sherman Vol #: 41
C 1202 M and D Ernst Vol #: 41
C 1203 J. Fox Vol #: 41
C 1204 D. Fox Vol #: 41
C 1205 S. Pawelski Vol #: 41
C 1206 M. Braxton Vol #: 42
C 1207 D. Reilly Vol #: 42
C 1208 P. Williams Vol #: 42
C 1209 A. Eagan Vol #: 42
C 1210 B. Dolph Vol #: 42
C 1211 J. Reynolds Vol #: 42
C 1212 E and R Gaumond Vol #: 42
C 1213 Illigible Vol #: 42
C 1214 T. Corrigan Vol #: 42
C 1215 M. Malleck Vol #: 42
C 1216 M. and P.Cason Vol #: 42
C 1217 P. Greninger Vol #: 42
C 1218 M. Devine Vol #: 42
C 1219 M. Caruso Vol #: 42
C 1220 M. McCabe Vol #: 42
C 1221 G. Buzanowicz Vol #: 42
C 1222 J. Cullen Vol #: 42
C 1223 R. Everts Vol #: 42
C 1224 M. Schlautman Vol #: 42
C 1225 W. Small Vol #: 42
C 1226 M. Wall Vol #: 42
C 1227 D. Rennie Vol #: 42
C 1228 J. Kozar Vol #: 42
C 1229 C.Harter Vol #: 42
C 1230 B. Mauch Vol #: 42
C 1231 M. Panaccion Vol #: 42
C 1232 M. Gillian Vol #: 42
C 1233 C. Tymon Vol #: 42
C 1234 J. Ripplinger Vol #: 42
C 1235 J. and L. Vetsch Vol #: 42
C 1236 I. Vetsch Vol #: 42
C 1237 E. Ripplinger Vol #: 42
C 1238 A. O'Brien Vol #: 42
C 1239 M. Janbe Vol #: 42
C 1240 L. and B. Norrell Vol #: 42
C 1241 M Janbe Vol #: 42
C 1242 C. Harter Vol #: 42
C 1243 D. Rennie Vol #: 42
C 1244 H. Sutton Vol #: 42
C 1245 F. Bungo Vol #: 42
C 1246 No signature Vol #: 42
C 1247 Chidren of God for Life Vol #: 43
2006D-0514 Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
GDL 1 Guidance Vol #: 1
2006P-0007 Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
PAV 1 FDA/CDER to Lachman Consultant Services, Inc. Vol #: 1
2006P-0173 Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
C 3 Evanston Northwestern Healthcare Vol #: 1
2006P-0285 Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing Duramed's NDA 21-544 for Seasonale
LET 1 FDA/CDER to Duramed Research, Inc. Vol #: 1
2006P-0287 determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
LET 1 FDA/CDER to Lachman Consultant Services, Inc. Vol #: 1
2006P-0311 Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
C 2 BenVenue Laboratories, Inc. Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 23 Vocies for Animals Vol #: 6
2006P-0415 Petition Seeking Regulation of Cloned Animals
C 43 S. Sevo Vol #: 5
2006P-0442 Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
SUP 1 Orchid Healthcare Vol #: 1
2006P-0487 Health Claim Petition: Isomaltulose and Dental Caries
C 1 Palatinit GmbH (Palatinit/Sudzucker) Vol #: 1
2007P-0028 Determine whether Seroquel, 150 mg ( quetiapine fumarate ) tablets ( NDA 20-639 ) has been withdrawn for safety or effectiveness reasons
ACK 1 FDA/DDM to Lachman Consultant Services, Inc Vol #: 1
CP 1 Lachman Consultant Services, Inc Vol #: 1

Page created on January 19, 2007 kk

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