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Dockets Management
Dockets Entered On May 16, 2006
Docket # Title
1976N-0052N OTC Nasal Decongestants
1981N-0022 OTC Weight Control Drug Products for Human Use
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006E-0206 Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
2006N-0181 Product Stability Data: Notice of Pilot Project
2006P-0090 Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
2006P-0205 Require Vitamin D be added to cereal-grain products
2006P-0207 ANDA Suitability for Cetirizine Hydrochloride Soft Gelatin Capsules 5mg and 10mg
2006P-0208 Permit the filing of an ANDA for Loratadine Soft Gelatin Capsules 10mg
2006P-0209 Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
1976N-0052N OTC Nasal Decongestants
C 250 Wyeth Consumer Heathcare Vol #: 98
1981N-0022 OTC Weight Control Drug Products for Human Use
C 128 Wyeth Consumer Healthcare Vol #: 110
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 17621 New Product Development Sedona Laboratories, Inc. Vol #: 162
LET 17622 Arizona Pharmaceuticals, LLC Vol #: 162
LET 17623 Enzymatic Therapy Vol #: 162
LET 17624 Enzymatic Therapy Vol #: 162
LET 17625 Enzymatic Therapy Vol #: 162
LET 17626 Perrigo Company of South Carolina Vol #: 162
LET 17627 Perrigo Company of South Carolina Vol #: 162
LET 17628 Perrigo Company of South Carolina Vol #: 162
LET 17629 Perrigo Company of South Carolina Vol #: 162
LET 17630 EarthLab, Inc.dba Wise Woman Herbals Vol #: 162
LET 17631 EarthLab, Inc. dba Wise Woman Herbals Vol #: 162
LET 17632 EarthLab, Inc. dba Wise Woman Herbals Vol #: 162
LET 17633 EarthLab, Inc. dba Wise Woman Herbals Vol #: 162
LET 17634 EarthLab, Inc. dba Wise Woman Herbals Vol #: 162
LET 17635 Advanced Metabolics Research Group Vol #: 162
LET 17636 Perrigo Company of South Carolina Vol #: 162
LET 17637 Perrigo Company of South Carolina Vol #: 162
LET 17638 Perrigo Company of South Carolina Vol #: 162
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 18269 G. Schuenemann Vol #: 516
C 18270 J. Schuenemann Vol #: 516
C 18271 L. Chamberlain, D.O. Vol #: 516
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 12863 G. Schuenemann Vol #: 806
C 12864 J. Schuenemann Vol #: 806
C 12865 L. Chamberlain, D.O. Vol #: 806
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
C 1387 W. Hill Vol #: 259
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 9289 E. Buck Vol #: 133
C 9290 E. Lundberg Vol #: 133
C 9291 A. Janks Vol #: 133
C 9292 L. Krawitz Vol #: 133
C 9293 D. J. Wilson Vol #: 133
C 9294 S. Williams Vol #: 133
C 9295 S. Hassinger Vol #: 133
C 9296 P. C. Light Vol #: 133
C 9297 Mrs. K. Caine Vol #: 133
C 9298 C. Bruckner Vol #: 133
C 9299 M. Kuntze Vol #: 133
C 9300 K. Steincipher-Eberle, M.D. Vol #: 133
C 9301 A. Matlock Vol #: 133
C 9302 J. Degabain Vol #: 133
C 9303 E. Garland Vol #: 133
C 9304 J. Degabain Vol #: 133
C 9305 M. Mattson Vol #: 133
C 9306 D. Bausano Vol #: 133
C 9307 D. Bausano Vol #: 133
C 9308 G. Plamondon Vol #: 133
C 9309 S. E. Bender Vol #: 133
C 9310 D. Clair, M.D. Vol #: 133
C 9311 M. Angle Vol #: 133
C 9312 S. Kirby Vol #: 133
C 9313 S. Dodd-Butters Vol #: 133
C 9314 E. Meuth Vol #: 133
C 9315 E. Fedewa Vol #: 133
C 9316 M. Workman Vol #: 133
C 9317 H. Vitullo Vol #: 133
C 9318 S. Sexton Vol #: 133
C 9319 C. Gonzalez Vol #: 133
C 9320 L. Harris Vol #: 133
C 9321 A. Stanton Vol #: 133
C 9322 D. Pittman Vol #: 133
C 9323 R. Lara Vol #: 133
C 9324 R. Barkins Vol #: 133
C 9325 P. A. Grace Vol #: 133
C 9326 M. Denham Vol #: 133
C 9327 C. Hiatt Vol #: 133
C 9328 M. Paltz Vol #: 133
C 9329 C. Swaim Vol #: 133
C 9330 M. E. Cairo Vol #: 133
C 9331 K. Stewart Vol #: 133
C 9332 J. Payne Vol #: 133
C 9333 V. McKee Vol #: 133
C 9334 D. Barrar Vol #: 133
C 9335 D. Barrar Vol #: 133
C 9336 M. Maks Vol #: 133
C 9337 K. Hill Vol #: 133
C 9338 K. Pearson-Bell Vol #: 133
C 9339 I. French Vol #: 133
C 9340 D. Steele Vol #: 133
C 9341 C. P. Acker Vol #: 133
C 9342 V. M. Akin Vol #: 133
C 9343 J. E. Sarin Vol #: 133
C 9344 G. Delon Vol #: 133
C 9345 B. Caskey Vol #: 133
C 9346 R. A. Caitland Vol #: 133
C 9347 J. M. Ambrose Vol #: 133
C 9348 J. Butler Vol #: 133
C 9349 C. Plaskett Vol #: 133
C 9350 T. Terry Vol #: 133
C 9351 S. Korotkin Vol #: 133
C 9352 J. Smith Vol #: 133
C 9353 J. K. Collins Vol #: 133
C 9354 R. Collins Vol #: 133
C 9355 P. Ingram Vol #: 133
C 9356 N. Stone Vol #: 133
C 9357 E. Engler Vol #: 133
C 9358 H. Lorraine Vol #: 133
C 9359 M. Grundling Vol #: 133
C 9360 C. Brown Vol #: 133
C 9361 J. Craven Vol #: 133
C 9362 B. S. Oakes Vol #: 133
C 9363 A. Higgins Vol #: 133
C 9364 B. L. McCarrell Vol #: 133
C 9365 D. Kassell Vol #: 133
C 9366 C. Londerback Vol #: 133
C 9367 P. Paul Vol #: 133
C 9368 B. G. Miller Vol #: 133
C 9369 A. McPhaul Vol #: 133
C 9370 P. Pickering Vol #: 133
C 9371 S. Williams Vol #: 133
C 9372 S. G. Crave Vol #: 133
C 9373 R. J. Miller Vol #: 133
C 9374 P. Wayne Vol #: 133
C 9375 P. J. Roth Vol #: 133
C 9376 D. Meyers Vol #: 133
C 9377 C. Christian Vol #: 133
C 9378 L. DeMasters Vol #: 133
C 9379 H. Donnelly Vol #: 133
C 9380 P. A. Dietor Vol #: 133
C 9381 L. Hammond Vol #: 133
C 9382 D. Guiffredo Vol #: 133
C 9383 L. D. Ames Vol #: 133
C 9384 B. Agadoni Vol #: 133
C 9385 B. L. Peters Wilson Vol #: 133
C 9386 S. Peirce Vol #: 133
C 9387 E. Stumber Vol #: 133
C 9388 J. Boelzner Vol #: 133
C 9389 P. Wilch Vol #: 133
C 9390 V. Baiardi Vol #: 133
C 9391 S. Alt DO Vol #: 133
C 9392 C. Alerakhin Vol #: 133
C 9393 A. Gled Vol #: 133
C 9394 S. L. Harbor Vol #: 133
C 9395 D. Medwick Vol #: 133
C 9396 J. Freer Vol #: 133
C 9397 J. Terry Vol #: 133
C 9398 L. Huber Vol #: 133
C 9399 C. W. Wakes Vol #: 133
C 9400 P. Kmeellorth Vol #: 133
C 9401 illegible Vol #: 133
C 9402 M. L. Vazquez Vol #: 133
EMC 1948 S. Alongi Vol #: 123
EMC 1949 D. Bosco Vol #: 123
EMC 1950 R. Gaffin Vol #: 123
EMC 1951 A. Johnson Vol #: 123
EMC 1952 C. Fay Vol #: 123
EMC 1953 J. Mixon Vol #: 123
EMC 1954 Dr. G. Bernard Vol #: 123
EMC 1955 J. Somers Vol #: 123
EMC 1956 C. Koeksal Vol #: 123
EMC 1957 N. Newland Vol #: 123
EMC 1958 M. Mancinelli Vol #: 123
EMC 1959 T. Leder Vol #: 123
EMC 1960 M. Conrad Vol #: 123
EMC 1961 L. Frieders Vol #: 123
EMC 1962 A. Merkley Vol #: 123
EMC 1963 S. Schlipf Vol #: 123
EMC 1964 S. Schlipf Vol #: 123
EMC 1965 C. Puopolo Vol #: 123
EMC 1966 J. Tarling Vol #: 123
EMC 1967 D. Abramschmitt Vol #: 123
EMC 1968 Dr. F. Franklin Vol #: 123
EMC 1969 D. Busichio Vol #: 123
EMC 1970 K. Morris Vol #: 123
EMC 1971 J. Henderson Vol #: 123
EMC 1972 P. Clymer Vol #: 123
EMC 1973 D. Reed Vol #: 123
EMC 1974 A. Kosch Vol #: 123
EMC 1975 M. Einsel Vol #: 123
EMC 1976 B. Sigman Vol #: 123
EMC 1977 J. Sumrall Vol #: 123
EMC 1978 B. Paape Vol #: 123
EMC 1979 J. Reinhart Vol #: 123
EMC 1980 D. Chadwick, R.Ph. Vol #: 123
EMC 1981 B. Miller Vol #: 123
EMC 1982 R. Gibson Vol #: 123
EMC 1983 C. Saddoris Vol #: 123
EMC 1984 L. Lieberman Vol #: 123
EMC 1985 M. Hadley Vol #: 123
EMC 1986 B. Davos Vol #: 123
EMC 1987 D. Cody Vol #: 123
EMC 1988 E. Kuester Vol #: 123
EMC 1989 L. Miranda Vol #: 123
EMC 1990 C. Valliere Vol #: 123
EMC 1991 E. Lieser Vol #: 123
EMC 1992 A. Sires Vol #: 123
EMC 1993 J. Robertson Vol #: 123
EMC 1994 B. Heller Vol #: 123
EMC 1995 R. Pratico Vol #: 123
EMC 1996 M. Storey Vol #: 123
EMC 1997 B. Grande Vol #: 123
EMC 1998 S. Davidson Vol #: 123
EMC 1999 N. Patel Vol #: 123
EMC 2000 L. Foulkes Vol #: 123
EMC 2001 K. Miller Vol #: 123
EMC 2002 Dr. C. Cimini Vol #: 123
EMC 2003 No signature Vol #: 123
EMC 2004 R. Normington Vol #: 123
EMC 2005 S. Ferraro Vol #: 123
EMC 2006 J. Ruesch Vol #: 123
EMC 2007 J. Brousseau Vol #: 123
EMC 2008 L. Young Vol #: 123
EMC 2009 M. McCarron, MSN, RNP Vol #: 123
EMC 2010 P. Bertram Vol #: 123
EMC 2011 C. Smith Vol #: 123
EMC 2012 B. Gilleran Vol #: 123
EMC 2013 P. Katra Vol #: 123
EMC 2014 D. McNearney Vol #: 123
EMC 2015 P. Mikeworth Vol #: 123
EMC 2016 C. Sidner Vol #: 123
EMC 2017 R. Booze Vol #: 123
EMC 2018 V. Beck Vol #: 123
EMC 2019 P. Holubec Vol #: 123
EMC 2020 R. George Vol #: 123
EMC 2021 G. Molkenthin Vol #: 123
EMC 2022 L. Bonnet Vol #: 123
EMC 2023 P. Lintz Vol #: 123
EMC 2024 J. Flanders Vol #: 123
EMC 2025 D. George Vol #: 123
EMC 2026 K. Wright Vol #: 123
EMC 2027 V. Olds Vol #: 123
EMC 2028 M. Villegas Vol #: 123
EMC 2029 C. Carri Vol #: 123
EMC 2030 M. Riddle Vol #: 123
EMC 2031 K. Wallander Vol #: 123
EMC 2032 A. Ortiz Vol #: 123
EMC 2033 C. Ficarra Vol #: 123
EMC 2034 S. Hagemann Vol #: 123
EMC 2035 C. Cedarburg Vol #: 123
EMC 2036 A. Picou Vol #: 123
EMC 2037 Dr. Brown Vol #: 123
EMC 2038 D. Erhard Vol #: 123
EMC 2039 M. Branch Vol #: 123
EMC 2040 B. Davis Vol #: 123
EMC 2041 J. Howard Vol #: 123
EMC 2042 K. Bery Vol #: 123
EMC 2043 M. Karant Vol #: 123
EMC 2044 S. Linderman Vol #: 123
EMC 2045 S. Santora Vol #: 123
EMC 2046 A. Johnston Vol #: 123
EMC 2047 L. Hamilton Vol #: 123
EMC 2048 L. Phillips Vol #: 123
EMC 2049 G. Miller Vol #: 123
EMC 2050 G. Gregg Vol #: 123
EMC 2051 M. Gregg Vol #: 123
EMC 2052 M. Citoli Vol #: 123
EMC 2053 K. Flaherty, J.D. Vol #: 123
EMC 2054 J. Sudbay Vol #: 123
EMC 2055 G. Jacobs Vol #: 123
EMC 2056 A. Stanton Vol #: 123
EMC 2057 L. Jones Vol #: 123
EMC 2058 K. Drew Vol #: 123
EMC 2059 L. Miles Vol #: 123
EMC 2060 E. Wright Vol #: 123
EMC 2061 J. Hatfield Vol #: 123
EMC 2062 A. Woody, RPh Vol #: 123
EMC 2063 L. Mulkey Vol #: 123
EMC 2064 S. King Vol #: 123
EMC 2065 K. Santellan Vol #: 123
EMC 2066 L. Ortiz Vol #: 123
EMC 2067 S. Barnard Vol #: 123
EMC 2068 T. Orth Vol #: 123
EMC 2069 M. Hansen Vol #: 123
EMC 2070 C. Osberg Vol #: 123
EMC 2071 C. Small Vol #: 123
EMC 2072 A. Sellers Vol #: 123
EMC 2073 M. Thurman Vol #: 123
EMC 2074 C. Edgett Vol #: 123
EMC 2075 M. Cadle Vol #: 123
EMC 2076 M. Webster Vol #: 123
EMC 2077 P. Salzmann Vol #: 123
EMC 2078 C. McCormick, R.N. Vol #: 123
EMC 2079 Dr. D. Woods Vol #: 123
EMC 2080 M. Davison Vol #: 123
EMC 2081 B. Harlingue Vol #: 123
EMC 2082 C. Godwin Vol #: 123
EMC 2083 C. Hart Vol #: 123
EMC 2084 B. Kennedy Vol #: 123
EMC 2085 R. Cirino Vol #: 123
EMC 2086 K. Newcomb Vol #: 123
EMC 2087 M. Wiley Vol #: 123
EMC 2088 P. Steele Vol #: 123
EMC 2089 M. Sickels Vol #: 123
EMC 2090 S. Lambert Vol #: 123
EMC 2091 J. Helgesen Vol #: 123
EMC 2092 A. Mein Vol #: 123
EMC 2093 C. Smith Vol #: 123
EMC 2094 S. Kalil Vol #: 123
EMC 2095 R. Wenrich Vol #: 123
EMC 2096 S. Peterson Vol #: 123
EMC 2097 S. Coughlin Vol #: 123
EMC 2098 C. Brischetto Vol #: 123
EMC 2099 P. Sorensen Vol #: 123
EMC 2100 D. Thomas Vol #: 123
EMC 2101 S. Frazier Vol #: 123
EMC 2102 B. Hicks Vol #: 123
EMC 2103 P. Bynum Vol #: 123
EMC 2104 M. Eppley Vol #: 123
EMC 2105 D. Davis Vol #: 123
EMC 2106 L. Landrum Vol #: 123
EMC 2107 J. Markel Vol #: 123
EMC 2108 J. Eberth Vol #: 123
EMC 2109 K. Wolfe Vol #: 123
EMC 2110 D. Beck, ND Vol #: 123
EMC 2111 D. Worden Vol #: 123
EMC 2112 J. Jordan Vol #: 123
EMC 2113 P. Anderson Vol #: 123
EMC 2114 N. Avedon Vol #: 123
EMC 2115 B. Wynn Vol #: 123
EMC 2116 P. Cleveland Vol #: 123
EMC 2117 E. Powell Vol #: 123
EMC 2118 P. Colby Vol #: 123
EMC 2119 D. Korcal Vol #: 123
EMC 2120 C. Gilbrech Vol #: 123
EMC 2121 A. Blackford Vol #: 123
EMC 2122 R. Robertson Vol #: 123
EMC 2123 K. Dater Vol #: 123
EMC 2124 A. Lorraine Vol #: 123
EMC 2125 I. Jasper Vol #: 123
EMC 2126 S. Morgan Vol #: 123
EMC 2127 G. Brooks Vol #: 123
EMC 2128 C. Curry Vol #: 123
EMC 2129 D. Simmons Vol #: 123
EMC 2130 J. Bean Vol #: 123
EMC 2131 S. Huschle Vol #: 123
EMC 2132 L. Kirby Vol #: 123
EMC 2133 M. Haley Vol #: 123
EMC 2134 R. Sponsel Vol #: 123
EMC 2135 P. Jones Vol #: 123
EMC 2136 Dr. T. Vance Vol #: 123
EMC 2137 P. Wilson Vol #: 123
EMC 2138 D. Goodson Vol #: 123
EMC 2139 B. McGee Vol #: 123
EMC 2140 S. Scruggs Vol #: 123
EMC 2141 N. McCarvill Vol #: 123
EMC 2142 S. Ricci Vol #: 123
EMC 2143 D. Fetrow Vol #: 123
EMC 2144 T. Hodel Vol #: 123
EMC 2145 M. Kelly Vol #: 123
EMC 2146 G. Martino Vol #: 123
EMC 2147 D. Fonte Vol #: 123
EMC 2148 R. Scott Vol #: 123
EMC 2149 D. Thalblum Vol #: 123
EMC 2150 A. Sherman Vol #: 123
EMC 2151 A. Erwin Vol #: 123
EMC 2152 C. Krallman Vol #: 123
EMC 2153 Dr. F. Pranno Vol #: 123
EMC 2154 C. Larouche Vol #: 123
EMC 2155 S. MacMillan Vol #: 123
EMC 2156 R. Steffen Vol #: 123
EMC 2157 N. Chilkov Vol #: 123
EMC 2158 N. Ruthenbeck Vol #: 123
EMC 2159 J. Pelzel Vol #: 123
EMC 2160 D. Handel Vol #: 123
EMC 2161 S. Dickens Vol #: 123
EMC 2162 D. Dobbins Vol #: 123
EMC 2163 R. Seedman, DVM Vol #: 123
EMC 2164 J. Fenderbosch Vol #: 123
EMC 2165 B. Hyda Vol #: 123
EMC 2166 M. Young Vol #: 123
EMC 2167 P. Myers Vol #: 123
EMC 2168 C. Hall Vol #: 123
EMC 2169 J. Todd Vol #: 123
EMC 2170 Dr. S. Murphree Vol #: 123
EMC 2171 A. Hays Vol #: 123
EMC 2172 J. Hays Vol #: 123
EMC 2173 C. Utter Vol #: 123
EMC 2174 L. Armer Vol #: 123
EMC 2175 D. Wills Vol #: 123
EMC 2176 C. McLeod Vol #: 123
EMC 2177 B. Albright Vol #: 123
EMC 2178 B. Curless Vol #: 123
EMC 2179 J. Bliss Vol #: 123
EMC 2180 J. Reese Vol #: 123
EMC 2181 K. Bryan Vol #: 123
EMC 2182 C. Maggiore Vol #: 123
EMC 2183 M. Collins Vol #: 123
EMC 2184 L. Brown Vol #: 123
EMC 2185 C. Carr Vol #: 123
EMC 2186 J. Goulart Vol #: 123
EMC 2187 C. Peterson Vol #: 123
EMC 2188 J. Sammons Vol #: 123
EMC 2189 J. Abel Vol #: 123
EMC 2190 D. Pantalion Vol #: 123
EMC 2191 H. James Vol #: 123
EMC 2192 R. Lively Vol #: 123
2006E-0206 Patent Extension Application for S8 Over-the-Wire System (Driver Stent Delivery System), U.S. Patent No. 6,159,229
APP 1 Medtronic Vascular Vol #: 1
LET 1 U.S. Patent and Trademark Office Vol #: 1
LET 2 U.S. Patent and Trademark Office Vol #: 1
2006N-0181 Product Stability Data: Notice of Pilot Project
N 1 FDA Vol #: 1
2006P-0090 Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
SUP 1 Xanodyne Pharmaceuticals, Inc. (Xanodyne) Vol #: 2
2006P-0205 Require Vitamin D be added to cereal-grain products
ACK 1 FDA/DDM to Rutgers, The State University Of New Jersey Vol #: 1
CP 1 Rutgers, The State University Of New Jersey Vol #: 1
2006P-0207 ANDA Suitability for Cetirizine Hydrochloride Soft Gelatin Capsules 5mg and 10mg
ACK 1 FDA/DDM to Strides Inc. Vol #: 1
CP 1 Strides Inc. Vol #: 1
2006P-0208 Permit the filing of an ANDA for Loratadine Soft Gelatin Capsules 10mg
ACK 1 FDA/DDM to Strides, Inc. Vol #: 1
CP 1 FDA/DDM to Strides, Inc. Vol #: 1
2006P-0209 Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
ACK 1 FDA/DDMB to Lachman Consultant Services, Inc. Vol #: 1
CP 1 Lachman Consultant Services, Inc. Vol #: 1

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