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Dockets Management
Dockets Entered On June 14, 2004
Table of Contents
Docket # Title
2000D-1392 Guidance for Industry on Botanical Drug Products
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002D-0509 Intl Conference on Harmonisation/M4 Common Technical Documen
2003P-0029 Remove metered-dose inhalers (MDI) containing moiety albuter
2004N-0018 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
2004P-0127 ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161)
2004P-0263 To declare that the drug Cefixine chewable tablets, 100 mg, 150 mg, and 200 mg are suitable for an abbreviated new drug application ( ANDA)
2000D-1392 Guidance for Industry on Botanical Drug Products
GDL 2 Guideline Vol #: 1
NAD 2 FDA Vol #: 1
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 105 Center for Veterinary Medicine Vol #: 410
EXB 106 Center for Veterinary Medicine Vol #: 410
EXB 107 Center for Veterinary Medicine Vol #: 410
EXB 108 Center for Veterinary Medicine Vol #: 410
EXB 109 Center for Veterinary Medicine Vol #: 410
EXB 110 Center for Veterinary Medicine Vol #: 410
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 1357 Form Letter Vol #: 249
C 1358 Form Letter Vol #: 250
C 1359 Form Letter Vol #: 251
C 1360 Form Letter Vol #: 252
C 1361 Form Letter Vol #: 253
C 1362 Form Letter Vol #: 254
C 1363 Form Letter Vol #: 255
C 1364 Form Letter Vol #: 256
C 1365 Form Letter Vol #: 257
C 1366 Form Letter Vol #: 258
C 1367 Form Letter Vol #: 259
C 1368 Form Letter Vol #: 260
C 1369 Form Letter Vol #: 261
C 1370 Form Letter Vol #: 262
C 1371 Form Letter Vol #: 263
C 1372 Form Letter Vol #: 264
C 1373 Form Letter Vol #: 265
C 1374 Form Letter Vol #: 266
C 1375 Form Letter Vol #: 267
C 1376 Form Letter Vol #: 268
C 1377 Form Letter Vol #: 269
C 1378 Form Letter Vol #: 270
EMC 7115 J. Bachman Vol #: 237
EMC 7116 L. Pyfer Vol #: 237
EMC 7117 R. U. Berg Vol #: 237
EMC 7118 J. Bryant Vol #: 237
EMC 7119 E. McCartney Vol #: 237
EMC 7120 L. Haris Vol #: 237
EMC 7121 H. Koop Vol #: 237
EMC 7122 J. A. Hanson Vol #: 237
EMC 7123 F. S. Drake Vol #: 237
EMC 7124 C. Hepburn Vol #: 237
EMC 7125 M. Waters Vol #: 237
EMC 7126 H. Saylor Vol #: 237
EMC 7127 L. Kiser Vol #: 237
EMC 7128 M. De Bruin Vol #: 237
EMC 7129 E. Canfield Vol #: 237
EMC 7130 T. White Vol #: 237
EMC 7131 S. Edwards Vol #: 237
EMC 7132 C. Ford-McCullaough Vol #: 237
EMC 7133 A. Delamater Vol #: 237
EMC 7134 C. Hogan Vol #: 237
EMC 7135 J. Schwener Vol #: 237
EMC 7136 J. Levijarvi Vol #: 237
EMC 7137 C. Brown Vol #: 237
EMC 7138 E. Epstein Vol #: 238
EMC 7139 S. Kaskus Vol #: 237
EMC 7140 A. De Lange Vol #: 237
EMC 7141 C. J. Stefano Vol #: 237
EMC 7142 D. Daley Vol #: 237
EMC 7143 K. Witney Vol #: 237
EMC 7144 E. A. Champagne Vol #: 237
EMC 7145 L. J. Bilger Vol #: 237
EMC 7146 C. Shopp Vol #: 237
EMC 7147 M. Amorocho Vol #: 237
EMC 7148 E. Batton Vol #: 237
EMC 7149 T. Traveler Vol #: 237
EMC 7150 A. Sunshine Vol #: 237
EMC 7151 A. Full Vol #: 237
EMC 7152 I. Matijick Vol #: 237
EMC 7153 G. Lake III Vol #: 237
EMC 7154 R. L. Sealy Vol #: 237
EMC 7155 D. Ruscoe Vol #: 237
EMC 7156 V. Price Vol #: 237
EMC 7157 Ms. M. L. Steere Vol #: 237
EMC 7158 J. R. Bragonier, MD Vol #: 237
EMC 7159 D. Klinke Vol #: 237
EMC 7160 A. Priest Vol #: 237
EMC 7161 C. Hoskins Vol #: 237
EMC 7162 J. Pollock Vol #: 237
EMC 7163 N. B. Cone Vol #: 237
EMC 7164 D. Wolking Vol #: 237
EMC 7165 J. A. Hall Vol #: 237
EMC 7166 N. Borowiak Vol #: 237
EMC 7167 E. Heitmeyer Vol #: 237
EMC 7168 C. Davidson Vol #: 237
EMC 7169 S. Holaday Vol #: 237
EMC 7170 J. Johnson Vol #: 237
EMC 7171 M. Ritchey Vol #: 237
EMC 7172 C. Saricks Vol #: 237
EMC 7173 S. J. Kahn Vol #: 237
2002D-0509 Intl Conference on Harmonisation/M4 Common Technical Documen
GDL 2 Guideline Vol #: 1
NAD 2 FDA Vol #: 1
2003P-0029 Remove metered-dose inhalers (MDI) containing moiety albuter
BKG 1 Background Material Vol #: 3
EA 1 HFD-7 Vol #: 3
FONS 1 HFD-7 Vol #: 3
NPR 1 FDA Vol #: 3
2004N-0018 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
NPR 1 FDA Vol #: 1
2004P-0127 ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161)
ACK 2 HFA-305 to Smart Drug Systems Inc. Vol #: 1
2004P-0263 To declare that the drug Cefixine chewable tablets, 100 mg, 150 mg, and 200 mg are suitable for an abbreviated new drug application ( ANDA)
ACK 1 HFA-305 to Lupin Pharmaceuticals, Inc. Vol #: 1
CP 1 Lupin Pharmaceuticals, Inc. Vol #: 1

Page created on June 15, 2004 dp

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