Food and Drug AdministrationDockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, 
Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870  [E-mail Us]

DOCKETS ENTERED on August 1, 2000

Table of Contents

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00P-0498 Exempt Swan-Ganz Pacing Catheters and Probes *
00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20 *
00P-1431 ANDA for elixir containing 10mg hydrocodone bitartrate/650mg *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

EMC 7 K Becker Vol#: 4

EMC 8 D Figler Vol#: 4

96M-0311 Guideline on Infectious Disease Issues in Xenotransplantatio

C 167 Alternatives Research & Development Vol#: 3
 

98D-0272 FDAMA Section 127 Pharmacy Compounding

C 12 International Academy of Compounding Pha Vol#: 1

98N-1038 Irradiation in the production, processing, &handling of food

C 5169 J Coalgate Vol#: 150

C 5170 M Wickelhaus Vol#: 150

C 5171 M Sardella Vol#: 150

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 56 J Lavoie-Staples Vol#: 186

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 148 I Weber Vol#: 16

EMC 149 D Stocchi Vol#: 16

EMC 150 S Temes Vol#: 16

EMC 151 M. J. Penner Vol#: 16

EMC 152 C Jurs Vol#: 16

EMC 153 S. Jay Vol#: 16

EMC 154 J Kogan Vol#: 16

EMC 155 K Lederman Vol#: 16

99P-2630 Establish a Daily Value for "added sugars"

C 125 NC Dental Society Vol#: 7

C 126 American Society of Bariatric Physicians Vol#: 7

EMC 4 National Council of Senior Citizens Vol#: 7

EMC 5 C Anastasio Vol#: 7
 

99P-4613 Revoke the Regulation That Approved Posilac

C 1126 M Conture Vol#: 40

C 1127 Lila Vol#: 40

C 1128 R Stauss Vol#: 40

C 1129 M Heinrich Vol#: 40

C 1130 Brett Vol#: 40

C 1131 No Signature Vol#: 40

C 1132 R Biggers Vol#: 40

C 1133 D Verner Vol#: 40

C 1134 A Herbert Vol#: 40

C 1135 J Thomas Vol#: 40

C 1136 R Hellen Vol#: 40

C 1137 G Blythe Vol#: 40

C 1138 M Day Vol#: 40

C 1139 D Rogler Vol#: 40

C 1140 Samuel Vol#: 40

C 1141 KA Vol#: 40

C 1142 W Kirkpecta Vol#: 40

C 1143 T Towsend Vol#: 40

C 1144 Y Kan Vol#: 40

C 1145 J Blake Vol#: 40

C 1146 P Rowe Vol#: 40

C 1147 H Stark Vol#: 40

C 1148 B Jares Vol#: 40

C 1149 A Tree Vol#: 40

C 1150 N Gayne Vol#: 40

C 1151 S Aldrich Vol#: 40

C 1152 No Signature Vol#: 40

C 1153 M Foster Vol#: 40

C 1154 D Marth Vol#: 40

C 1155 illegible Vol#: 40

C 1156 RAA Vol#: 40

C 1157 C Anderson Vol#: 40

C 1158 David Vol#: 40

C 1159 Rich Vol#: 40

C 1160 P. Straubu Vol#: 40

C 1161 No signature Vol#: 40

C 1162 CJ Jaeger Vol#: 40

C 1163 M Mackenti Vol#: 40

C 1164 D Brown Vol#: 40

C 1165 J Olsen Vol#: 40

C 1166 J Simon Vol#: 40

C 1167 J Jacky Vol#: 40

C 1168 R Meyers Vol#: 40

C 1169 B Batlof Vol#: 40

C 1170 H Korich Vol#: 40

C 1171 Scott Vol#: 40

C 1172 S Furman Vol#: 40

C 1173 Illegible Vol#: 40

C 1174 K Oneil Vol#: 40

C 1175 K Hegarty Vol#: 40

C 1176 B Souey Vol#: 40

C 1177 B Ritche Vol#: 40

C 1178 A Wright Vol#: 40

C 1179 D Cagehill Vol#: 40

C 1180 S. Crane Vol#: 40

C 1181 Carly Vol#: 40

C 1182 P Straut Vol#: 40

C 1183 A Sachar Vol#: 40

C 1184 A Roat Vol#: 40

C 1185 H White Vol#: 40

C 1186 G Farrinede Vol#: 40

C 1187 No signature Vol#: 40

C 1188 D. Baker Vol#: 40

C 1189 C Haywood Vol#: 40

C 1190 A Robelotto Vol#: 40

C 1191 D Schmitt Vol#: 40

C 1192 J. Garzon Vol#: 40

C 1193 A.M. Weiss Vol#: 40

C 1194 Sharon Vol#: 40

C 1195 No signature Vol#: 40

C 1196 Greg Vol#: 40

C 1197 No signature Vol#: 40

C 1198 D Clinton Vol#: 40

C 1199 T Beauvais Vol#: 40

C 1200 Maria Vol#: 40

C 1201 Jarod Vol#: 40

C 1202 Jarod Vol#: 40

C 1203 G Thesing Vol#: 40

C 1204 C Buss Vol#: 40

C 1205 M Sonyer Vol#: 40

C 1206 B Cabbe Vol#: 40

C 1207 L Chisholm Vol#: 40

C 1208 No signature Vol#: 40

C 1209 C Johnson Vol#: 40

C 1210 Illegible Vol#: 40

C 1211 J. Fond Vol#: 40

C 1212 B Oetjin Vol#: 40

C 1213 K Flewelling Vol#: 40

C 1214 B Carson Vol#: 40

C 1215 S Plumb Vol#: 40

C 1216 J Pasinea Vol#: 40

C 1217 N Cosby Vol#: 40

C 1218 No signature Vol#: 40

C 1219 Susan Vol#: 40

C 1220 Rachel Vol#: 40

C 1221 S Neunman Vol#: 40

C 1222 K Kaufman Vol#: 40

C 1223 A Pinto Vol#: 40

C 1224 Nina Vol#: 40

C 1225 Joshua P. Vol#: 40

00D-1306 Content & Format of Prescription Drug Labeling

C 1 L England Vol#: 1
 

00M-0809 P990034; Cellugel Ophthalmic Viscosurgical Device

CR 1 Alcon Laboratories Vol#: 1
 

00M-1414 P990018 Menicon Ztm(tisilfocon A)Rigid Gas Permeable Lens

AAV 1 Menicon U.S.A., Inc Vol#: 1
 

00M-1415 P000006 Mentor Alpha 1 Inflatable Penile Prosthesis

AAV 1 Mentor Corp Vol#: 1
 

00M-1416 P990064 Mosaic Porcine Bioprosthesis, Models 305 and 310

AAV 1 Medtronic, Inc Vol#: 1
 

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

NM 1 Meeting on 8/14-15/00 Vol#: 1

00P-0498 Exempt Swan-Ganz Pacing Catheters and Probes

EXP 1 Edwards Vol#: 1

00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20

C 4 Lord, Bissell & Brook Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 3495 J MacIsaac Vol#: 140

C 3496 R Benberg Vol#: 140

C 3497 S Vasigh Vol#: 140

C 3498 L Pelski Vol#: 140

C 3499 A. Bowling Vol#: 140

>C 3500 S Hermes Vol#: 140

>C 3501 D Orlowski Vol#: 140

C 3502 E. Ewart Vol#: 140

C 3503 E Bartlett Vol#: 140

>C 3504 C Longhaft Vol#: 140

C 3505 P Tuff Vol#: 140

C 3506 F. M. Redmond Vol#: 140

C 3507 A Shehadi Vol#: 140

C 3508 T Van Hecke Vol#: 140

C 3509 M. Rapp Vol#: 140

C 3510 S Berger Vol#: 140

C 3511 G Kasdan Vol#: 140

C 3512 M Morin Vol#: 140

>C 3513 J. Bergman Vol#: 140

C 3514 J Blakely Vol#: 140

C 3515 J Cust Vol#: 140

C 3516 C Golus Vol#: 140

C 3517 B Ceurvorst Vol#: 140

C 3518 C Rose Vol#: 140

C 3519 D Miller Vol#: 140

C 3520 C Burden Vol#: 140

C 3521 N. Jones Vol#: 140

C 3522 P. Smith Vol#: 140

>C 3523 P Jurek Vol#: 140

C 3524 M. Goode Vol#: 140

C 3525 A Daniti Vol#: 140

C 3526 L Lehner Vol#: 140

C 3527 P. J. Banks Vol#: 140

C 3528 B Souter Vol#: 140

C 3529 R Dobkin Vol#: 140

C 3530 L Romaine Vol#: 140

C 3531 L Hebbar Vol#: 140

C 3532 J Zema Vol#: 140

C 3533 E Welch Vol#: 140

C 3534 A Moore Vol#: 140

C 3535 J McCormick Vol#: 140

C 3536 R Richard Vol#: 140

C 3537 C. Michel Vol#: 140

C 3538 S Kenkel Vol#: 140

C 3539 E Wilson Vol#: 140

C 3540 S Ireland Vol#: 140

C 3541 L Symons Vol#: 140

C 3542 B Baldwin Vol#: 140

C 3543 N. L. McConnell Vol#: 140

C 3544 G. Barnes Vol#: 140

EMC 508 V King Vol#: 140

EMC 509 S. Schnedier Vol#: 140

EMC 510 T Roscetti Vol#: 140

EMC 511 B Van Wicklen Vol#: 140

EMC 512 L Eihardt Vol#: 140

EMC 513 B Van Wicklen Vol#: 140

EMC 514 K Kouyoumjian Vol#: 140

EMC 515 S Guegan Vol#: 140

EMC 516 E Bonaparte Vol#: 140

EMC 517 A Pate Vol#: 140

00P-1431 ANDA for elixir containing 10mg hydrocodone bitartrate/650mg

ACK 1 HFA-305 Vol#: 1

CP 1 Pai Pharmaceutical Associates, Inc. Vol#: 1