| Food and Drug Administration,
Dockets Management Branch, 5630 Fishers
Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870
[E-mail]
DOCKETS ENTERED on November 9, 1999 Table of Contents(Hyper links are part of the Docket title - not all dockets/documents are linked) |
|
97N-484S Human Cellular and Tissue-Based Products * 98P-0145 Requirements for demonstrating In Vivo Bioequivalence * 99N-3089 Draft Affirmative Agenda for International Activities * 99P-4870 ANDA for Sterile Cefazolin Sodium, USP * 99P-4871 ANDA for Sterile Cefuroxime Sodium, USP * |
C 3 Sander S Shapiro MD Vol#: 6
C 4 James A Grifo MD PhD Vol#: 6
98P-0145 Requirements for demonstrating In Vivo Bioequivalence
PRC 1 Andrx Pharmaceuticals, Inc. Vol#: 6
99H-1448 Civil Money Penalties;Donald German,d/b/a The Alibi
CS 3 HFA-305 Vol#: 1
OR 2 HF-3 Vol#: 1
99H-4177 Civil Money Penalty:Interstate Foods Inc dba the Curb Store
ANS 1 Interstate Foods Inc Vol#: 1
99H-4249 Civil Money Penalty;Maverik Country Stores Inc,dba Maverik
ANS 1 Maverik Country Store #273 Vol#: 1
99H-4398 Civil Money Penalty;Merit Oil Corp,dba Merit Gas Station
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4523 Civil Money Penalty;Auto Service & Supply Co Inc,dba West Te
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4524 Civil Money Penalty;Buco Liquors Inc,dba Buco Liquors
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4525 Civil Money Penalty;Cumberland Farms Inc,dba Cumberland Farm
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4526 Civil Money Penalty;Doris' Market Inc,dba Doris' Market
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4527 Civil Money Penalty;E-Z Mart Stores Inc,dba E Z Mart Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4528 Civil Money Penalty;Happy Harry's Inc,dba Harry Harry's Inc
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4529 Civil Money Penalty;Thu Le,dba J & J Discount Mini Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4530 Civil Money Penalty;Guilermo Nalo,dba Casa Victoria
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4531 Civil Money Penalty;Toufic E Raad,dba Rockdale Getty
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4532 Civil Money Penalty;Shore Stop Corp,dba Shore Stop Express
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4533 Civil Money Penalty;Break Pointe Stores Inc,dba Break Point
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4534 Civil Money Penalty;C & S 2000 Corporation,dba First Stop
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4535 Civil Money Penalty;Gilson's Minit Mart Inc,dba Gilson Minit
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4536 Civil Money Penalty;Jenny Kollasch & Steve Kollasch,dba Banc
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4537 Civil Money Penalty;Morris Marketers Inc,dba Shell Food Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4538 Civil Money Penalty;Multicorp Management Group Inc,dba Shell
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4539
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4540 Civil Money Penalty;Pat's Super Market Inc,dba Pat's Foods
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4541 Civil Money Penalty;Tedeschi Food Shops Inc,dba Li'L Peach
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-4542 Civil Money Penalty;Wawa Inc,dba Wawa Food Market #830
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99N-3089 Draft Affirmative Agenda for International Activities
C 6 National Fisheries Institute Vol#: 1
C 7 Center for Science in the Public Interes Vol#: 1
LET 1 Center for Science in the Public Interes Vol#: 1
99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
EMC 82 Irene Bensinger Vol#: 1
EMC 83 Julia A Harris Vol#: 1
EMC 84 Leanne T Goodsell Vol#: 1
EMC 85 Kathleen B Pursifull Vol#: 1
EMC 86 Robin Allen-Paris Vol#: 1
EMC 87 Sabrina Johnston Vol#: 1
EMC 88 Jean-Francois P Trahan Vol#: 1
EMC 89 Taylor R Felker Vol#: 1
EMC 90 Cindy Hauserman Vol#: 1
EMC 91 Elizabeth T Brown Vol#: 1
EMC 92 Laura D Todd Vol#: 1
EMC 93 Bobbie D Flowers Vol#: 1
EMC 94 Richard W Layman Vol#: 1
EMC 95 Kathleen E Dolphin Vol#: 1
EMC 96 Angela M Priest Vol#: 1
EMC 97 Erik A Farseth Vol#: 1
EMC 98 Jill Gambino Vol#: 1
EMC 99 Kris Morahn Vol#: 1
EMC 100 Kristie L Mobley Vol#: 1
EMC 101 Molly B Campbell Vol#: 1
EMC 102 Kyle A Slesicki Vol#: 1
EMC 103 Tanya Tiedje Vol#: 1
EMC 104 Irene Mills Vol#: 1
EMC 105 James E Holdman Vol#: 1
EMC 106 Bonnie Shay Vol#:
EMC 107 Debbie Ortman Vol#: 1
EMC 108 Heidi MacKay Vol#: 1
EMC 109 Susan C Ferry Vol#: 1
EMC 110 David Powelson Vol#: 1
EMC 111 Daniel J Highkin MD Vol#: 1
EMC 112 Form letter count 170 Vol#: 2
EMC 113 Kathy Moffat Vol#: 1
EMC 114 Mary Elsia Wu Vol#: 1
EMC 115 Dana B Randell Vol#: 1
EMC 116 Carolyn Banks Vol#: 1
EMC 117 Jeffrey Kirk Vol#: 1
EMC 118 Clifford Ginn Vol#: 1
EMC 119 Michele N Styer Vol#: 1
EMC 120 Lauretta Lange Vol#: 1
EMC 121 Leda A G Huta Vol#: 1
EMC 122 Gregory E Albertson Vol#: 1
EMC 123 Sarah Sockit Vol#: 1
EMC 124 Nancy E Lawler Vol#: 1
EMC 125 Lynn R Rossiter Vol#: 1
EMC 126 David T Fryer Vol#: 1
EMC 127 Taran D Singleton Vol#: 1
EMC 128 Karen M Ellis Vol#: 1
EMC 129 Jean-Paul Ladner Jr Vol#: 1
EMC 130 Michael S Gardner Vol#: 1
EMC 131 Judith A Detert-Moriarty Vol#: 1
EMC 132 Donald F Grbac Vol#: 1
EMC 133 Judith E Stevens Vol#: 1
EMC 134 Corby Harper Vol#: 1
EMC 135 Desiree I Cole Vol#: 1
EMC 136 Ryan N Weemhoff Vol#: 1
EMC 137 S Christopher Jacobs Vol#: 1
EMC 138 Olivia K McIntosh Vol#: 1
EMC 139 Melanie N St James Vol#: 1
EMC 140 Nancy B Spears Vol#: 1
EMC 141 Loretta E Dunne Vol#: 1
EMC 142 Jeffrey M Thompson Vol#: 1
EMC 143 Joan Ambo Vol#: 1
EMC 144 Caleb M Rollo Vol#: 1
EMC 145 Simona Vogel Vol#: 1
EMC 146 Alfred S Fuller Vol#: 1
EMC 147 Ann Chen Vol#: 1
EMC 148 Melissa A Gilham Vol#: 3
EMC 149 Rob Dickerson Vol#: 3
EMC 150 David W Koenig Vol#: 3
EMC 151 Farrah R McKenzie Vol#: 3
EMC 152 Elizabeth Anders Vol#: 3
EMC 153 Kim J Gant Vol#: 3
EMC 154 Mark A Moran Vol#: 3
EMC 155 Alison J Luedecke Vol#: 3
EMC 156 Carole Connet Vol#: 3
EMC 157 Frederik E Jente Vol#: 3
EMC 158 Katherine Hamil Vol#: 3
EMC 159 Form letter count 26 Vol#: 4
EMC 160 Carol A Allee Vol#: 3
EMC 161 Jane A Jensen Vol#: 3
EMC 162 Megan A Robbins Vol#: 3
EMC 163 Jon H Widhmann Vol#: 3
EMC 164 Keren Kaufman Vol#: 3
EMC 165 Bob Rozett Vol#: 3
EMC 166 Dennis Adsit PhD Vol#: 3
EMC 167 Jane Winn Vol#: 3
EMC 168 Linda Bystrak Vol#: 3
EMC 169 Grace Erhart Vol#: 3
EMC 170 David Saunders Vol#: 3
EMC 171 Jerome Mc Collom Vol#: 3
EMC 172 Yvonne Duprez Vol#: 3
EMC 173 Ramon Puga Vol#: 3
EMC 174 Andrew Butz Vol#: 3
EMC 175 Thomas Aquilla Vol#: 3
EMC 176 Patricia A Bosi Vol#: 3
EMC 177 Mano Vol#: 3
EMC 178 Kristen M Tuinstra Vol#: 3
EMC 179 Lynne Mason Vol#: 3
EMC 180 Jason D Schnarr Vol#: 3
EMC 181 Michele Delehanty Vol#: 3
EMC 182 Salma J Shamy Vol#: 3
EMC 183 Carolyn P Higgins Vol#: 3
EMC 184 Roberto O Lozano Vol#: 3
EMC 185 Eric Obleman Vol#: 3
EMC 186 Anna Walters Vol#: 3
EMC 187 Leigh B Brooks Vol#: 3
EMC 188 William J Greene Vol#: 3
EMC 189 Jennifer K Elrod Vol#: 3
EMC 190 Jeffrey A Ensminger Vol#: 3
EMC 191 Tony Kaperick Vol#: 3
EMC 192 Lakshmi K Khalsa Vol#: 3
EMC 193 Nancy A Salle Vol#: 3
EMC 194 Jason A Walker Vol#: 3
EMC 195 Chris Frantzen Vol#: 3
EMC 196 Emily D Kaufman Vol#: 3
EMC 197 Walter Muelken Vol#: 3
EMC 198 Gina L Marchini Vol#: 3
EMC 199 Scott A Woodard Vol#: 3
EMC 200 Form letter count 162 Vol#: 5
EMC 201 Dr Jonathan Matthews Vol#: 3
EMC 202 Juliann Barbatp Vol#: 3
EMC 203 Leslie Pelch Vol#: 3
EMC 204 Ann Beth Vol#: 3
EMC 205 Dr Margaret Hammitt-McDonald Vol#: 3
EMC 206 Sherry M Freeman Vol#: 3
EMC 207 Irene Bensinger Vol#: 3
EMC 208 Robin Ticciati Vol#: 3
EMC 209 Patricia Youngson Vol#: 3
EMC 210 Samuel R Horton Vol#: 3
EMC 211 Crystal L Voyles Vol#: 3
EMC 212 Christine E Lorenz Vol#: 3
EMC 213 Forrest S Beal Vol#: 3
EMC 214 Mark M Giese Vol#: 3
EMC 215 Cynthia M Weiss Vol#: 3
EMC 216 Duncan Macomber Vol#: 3
EMC 217 L Gilmartin Vol#: 3
EMC 218 Pamela E Forsyth Vol#: 3
EMC 219 John M Gear Vol#: 3
EMC 220 David Klein Vol#: 3
EMC 221 Darlene A Behnke Vol#: 3
EMC 222 Marta D Moskowitz Vol#: 3
EMC 223 Tony Kaperick Vol#: 3
EMC 224 John L Noyes MD Vol#: 3
EMC 225 Yuri I Huta Vol#: 3
EMC 226 Roland Shafer Vol#: 3
EMC 227 David E Turner Vol#: 3
EMC 228 Jennet Grover Vol#: 3
99P-4870 ANDA for Sterile Cefazolin Sodium, USP
THESE LINKED COMMENTS DUPLICATE THOSE IN 99P-4871, ALSO BELOW
CP 1 Quinn Consulting Services Vol#: 1
99P-4871 ANDA for Sterile Cefuroxime Sodium, USP
ACK 1 HFA-305 Vol#: 1
CP 1 Quinn Consulting Services Vol#: 1