FDA Logo links to FDA home page
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

FDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status

horizonal rule

Dockets Management
Dockets Entered On March 11, 2004
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products
2003D-0493 Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
2003D-0558 Guidance Levels for Radionuclides in Domestic and Imported Foods
2003N-0069 FDA Task Force on Consumer Health Info for Better Nutrition
2003N-0496 Food Labeling: Health Claims; Dietary Guidance
2003P-0029 Remove metered-dose inhalers (MDI) containing moiety albuter
2003P-0266 Lovenos(enoxaparin sodlium),NDA 20-164(90mg/0.6ml(product number 006),was not withdrawn from sale for reasons of safety or effectiveness sponsored by Aventis Pharmaceuticalls inc.
2003Q-0559 Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
2004D-0028 Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
2004N-0087 Request for Comment on Generic Drug Issues
2004P-0105 Nutrient Content Claim: Total Carbohydrate Content of Foods
2004P-0107 Nutrient Content Claim: Carbohydrate Content of Foods
2004P-0110 Nutrient Content Claim: Carbohydrate Content of Foods
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 13156 NBTY Inc. Vol #: 107
LET 13157 NBTY Inc. Vol #: 107
LET 13158 NBTY Inc. Vol #: 107
LET 13159 NBTY Inc. Vol #: 107
LET 13160 NBTY Inc. Vol #: 107
LET 13161 NBTY Inc. Vol #: 107
LET 13162 NBTY Inc. Vol #: 107
LET 13163 NBTY Inc. Vol #: 107
LET 13164 NBTY Inc. Vol #: 107
LET 13165 NBTY Inc. Vol #: 107
LET 13166 NBTY Inc. Vol #: 107
LET 13167 NBTY Inc. Vol #: 107
LET 13168 NBTY Inc. Vol #: 107
LET 13169 NBTY Inc. Vol #: 107
LET 13170 NBTY Inc. Vol #: 107
LET 13171 NBTY Inc. Vol #: 107
LET 13172 NBTY Inc. Vol #: 107
LET 13173 NBTY Inc. Vol #: 107
LET 13174 NBTY Inc. Vol #: 107
LET 13175 NBTY Inc. Vol #: 107
LET 13176 NBTY Inc. Vol #: 107
LET 13177 NBTY Inc. Vol #: 107
LET 13178 NBTY Inc. Vol #: 107
LET 13179 NBTY Inc. Vol #: 107
LET 13180 NBTY Inc. Vol #: 107
LET 13181 NBTY Inc. Vol #: 107
LET 13182 NBTY Inc. Vol #: 107
LET 13183 NBTY Inc. Vol #: 107
LET 13184 NBTY Inc. Vol #: 107
LET 13185 NBTY Inc. Vol #: 107
LET 13186 NBTY Inc. Vol #: 107
LET 13187 NBTY Inc. Vol #: 107
LET 13188 NBTY Inc. Vol #: 107
LET 13189 NBTY Inc. Vol #: 107
LET 13190 NBTY Inc. Vol #: 107
LET 13191 NBTY Inc. Vol #: 107
LET 13192 NBTY Inc. Vol #: 107
LET 13193 NBTY Inc. Vol #: 107
LET 13194 NBTY Inc. Vol #: 107
LET 13195 NBTY Inc. Vol #: 107
LET 13196 NBTY Inc. Vol #: 107
LET 13197 NBTY Inc. Vol #: 107
LET 13198 NBTY Inc. Vol #: 107
LET 13199 NBTY Inc. Vol #: 107
LET 13200 NBTY Inc. Vol #: 107
LET 13201 NBTY Inc. Vol #: 107
LET 13202 NBTY Inc. Vol #: 107
LET 13203 NBTY Inc. Vol #: 107
LET 13204 NBTY Inc. Vol #: 107
LET 13205 NBTY Inc. Vol #: 107
LET 13206 New Chapter, Inc. Vol #: 107
LET 13207 New Chapter, Inc. Vol #: 107
LET 13208 New Chapter, Inc. Vol #: 107
LET 13209 Se-cure Pharmaceuticals Ltd. Vol #: 107
LET 13210 Source Naturals Vol #: 107
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
LET 736 HFS-800 to Earthlab, Inc. Vol #: 22
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7392 J. Girgen, JD Vol #: 307
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 4144 M. Remillet-Sutton Vol #: 168
EMC 4145 T. Martin Vol #: 168
EMC 4146 L. Bartholomae Vol #: 168
EMC 4147 C. Thompson Vol #: 168
EMC 4148 M. T. Rekers Vol #: 168
EMC 4149 S. Mulcahy Vol #: 168
EMC 4150 K. Angel Vol #: 168
EMC 4151 G. Lewis Vol #: 168
EMC 4152 W. Wheeler Vol #: 168
EMC 4153 E. McPherson Vol #: 168
EMC 4154 K. Dorce Vol #: 168
EMC 4155 D. V. Hoyt III Vol #: 168
EMC 4156 E. Hoppenbrouwers Vol #: 168
EMC 4157 D. J. Lafond Vol #: 168
EMC 4158 S. Stokes Vol #: 168
EMC 4159 A. Stroup Vol #: 168
EMC 4160 P. Rousselot Vol #: 168
EMC 4161 N. J. F. Harrison Vol #: 168
EMC 4162 W. Nelson Vol #: 168
EMC 4163 S. Anderson Vol #: 168
EMC 4164 A. L Romasco Vol #: 168
EMC 4165 L. Belk Vol #: 168
EMC 4166 R. Killough-Hill Vol #: 168
EMC 4167 P. Goldstein Vol #: 168
EMC 4168 M. Pouti Vol #: 168
EMC 4169 M. Brown Vol #: 167
EMC 4170 A. A. Forsberg Vol #: 168
EMC 4171 G. Mason Vol #: 168
EMC 4172 C.Farina Vol #: 168
EMC 4173 A. Fichandler Vol #: 168
EMC 4174 A. Lichtman Vol #: 168
EMC 4175 K. Valkner Vol #: 168
EMC 4176 A. Gerecke Jr. Vol #: 168
EMC 4177 A. Babcock Vol #: 168
EMC 4178 A McGinty Vol #: 168
EMC 4179 J. Pearl Vol #: 168
EMC 4180 N. Wissman Vol #: 168
EMC 4181 B. P. Do Vol #: 168
EMC 4182 B. Branham Vol #: 168
EMC 4183 J. Potter Vol #: 168
EMC 4184 M. Robinson Vol #: 168
EMC 4185 T. Roben Vol #: 168
EMC 4186 J. Fiore Vol #: 168
EMC 4187 S. L Chambers Vol #: 168
EMC 4188 S. Johnson Vol #: 168
EMC 4189 L. Richard Vol #: 168
EMC 4190 Mr. L. D. Rockwell Vol #: 168
EMC 4191 M. Hideki Vol #: 168
EMC 4192 S. Smith Vol #: 168
EMC 4193 P. Haas Vol #: 167
EMC 4194 J. Mangan Vol #: 168
EMC 4195 S. Akerman Vol #: 168
EMC 4196 E. Miranti Vol #: 168
EMC 4197 P. A. Coomer Vol #: 168
EMC 4198 J. Demay Vol #: 168
EMC 4199 B. Wolper Vol #: 168
EMC 4200 T. Cusick Vol #: 168
EMC 4201 D. Meisberger Vol #: 168
EMC 4202 A. C. Sheldon Vol #: 168
EMC 4203 R. Squires Vol #: 168
EMC 4204 J. Stewart Vol #: 168
EMC 4205 B. Koh Vol #: 168
EMC 4206 W. Gates Vol #: 168
EMC 4207 J. Davis Vol #: 168
EMC 4208 S. Pepperwood Vol #: 168
EMC 4209 C. A. Hains Vol #: 168
EMC 4210 D. Mueller Vol #: 168
EMC 4211 L. N. Jabine M.D. Vol #: 168
EMC 4212 S. Merrick Vol #: 168
EMC 4213 M. Stimson Vol #: 168
EMC 4214 V. Shannon Vol #: 168
EMC 4215 J. Drennan-Broilo Vol #: 168
EMC 4216 P. Balmaceda Vol #: 168
EMC 4217 K. Meagher Vol #: 168
EMC 4218 T. Pickard Vol #: 168
EMC 4219 C. Hall Vol #: 168
EMC 4220 J. Richardson Vol #: 168
2002P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products
LET 3
Attachment
HFD-7 to Coington & Burling Vol #: 1
2003D-0493 Guidance on Powder Blends and Finished Dosage Units -- Stratified In-Process Dosage Unit Sampling and Assessmen
C 7 Pharmaceutical Research and Manufacturers of America (PhRMA) Vol #: 1
C 8 Johnson & Johnson Pharmaceutical Research (Johnson-Johnson) Vol #: 1
C 9 Amgen, Inc. Vol #: 1
C 10 Wyeth Pharmaceuticals Vol #: 1
2003D-0558 Guidance Levels for Radionuclides in Domestic and Imported Foods
C 1 California Department of Health Services Vol #: 1
2003N-0069 FDA Task Force on Consumer Health Info for Better Nutrition
C 7 Honorable Russell D. Feingold Vol #: 5
2003N-0496 Food Labeling: Health Claims; Dietary Guidance
C 32 Nestle USA Vol #: 7
C 33 Produce for Better Health Foundation (PBH) Vol #: 7
2003P-0029 Remove metered-dose inhalers (MDI) containing moiety albuter
SUP 4 International Pharmaceutical Aerosol Consortium (IPAC) Vol #: 1
SUP 5 GlaxoSmithKline (GSK) Vol #: 1
2003P-0266 Lovenos(enoxaparin sodlium),NDA 20-164(90mg/0.6ml(product number 006),was not withdrawn from sale for reasons of safety or effectiveness sponsored by Aventis Pharmaceuticalls inc.
LET 2 HFD-7 to Olsson, Frank and Weeda, PC Vol #: 1
2003Q-0559 Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease
C 7 AMD Oil Sales LLC dba JCMD Sales Vol #: 5
C 8 East Coast Olive Oil Vol #: 5
C 9 Hormel Foods Corporation Vol #: 5
C 10 Catania-Spagna Vol #: 5
C 11 Finex Trade Vol #: 5
C 12 Filippo Berio Olive Oil Vol #: 5
C 13 National Food Trading Corp Vol #: 5
C 14 Prodotti Mediterranei Inc Vol #: 5
C 15 Admiration Foods Vol #: 5
2004D-0028 Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
C 1 D. Lenehan Vol #: 1
C 2 L. Dunne Vol #: 1
C 3 N. Rapp Vol #: 1
C 4 C. Wistar Vol #: 1
C 5 C. Hsu Vol #: 1
C 6 M. Ramphal Vol #: 1
C 7 M. Morrison Vol #: 1
C 8 A. Bellomo Vol #: 1
C 9 F. Weiersmueller Vol #: 1
C 10 R. Niswander Vol #: 1
EMC 160 P. Gronbeck Vol #: 2
EMC 161 R. and N. Diaz Vol #: 2
EMC 162 R. Coble Vol #: 2
EMC 163 L. Davis Vol #: 2
EMC 164 H. Guthmann Vol #: 2
EMC 165 G. Farmer Vol #: 2
EMC 166 R. Buttacavoli Vol #: 2
EMC 167 P. Lee Vol #: 2
EMC 168 J. Belanger Vol #: 2
EMC 169 E. Jackson Vol #: 2
EMC 170 A. Sprayregen Vol #: 2
EMC 171 J. Anderson Vol #: 2
EMC 172 E. Mitchell Vol #: 2
EMC 173 M. Beaulne Vol #: 2
EMC 174 R. Albaugh Vol #: 2
EMC 175 E. Homeier Vol #: 2
EMC 176 P. Hopkins Vol #: 2
EMC 177 C. Allen Vol #: 2
EMC 178 L. Cowan Vol #: 2
EMC 179 T. Jouany Vol #: 2
EMC 180 D. Cothran Vol #: 2
EMC 181 L. Buttrey Vol #: 2
EMC 182 D. Dexheimer Vol #: 2
EMC 183 R. Marcouiller Vol #: 2
EMC 184 B. McGee Vol #: 2
EMC 185 M. Steinkamp Vol #: 2
EMC 186 D. Hunt Vol #: 2
EMC 187 Dr. W. Aller, PhD Vol #: 2
EMC 188 B. Kreiman Vol #: 2
EMC 189 G. Merolle Vol #: 2
EMC 190 A. Kruger Vol #: 2
EMC 191 D. Mirza Vol #: 2
EMC 192 K. Dame Vol #: 2
EMC 193 H. Sherer Vol #: 2
EMC 194 D. Dalton Vol #: 2
EMC 195 N. and S. Kirschbaum Vol #: 2
EMC 196 T. Medford Vol #: 2
EMC 197 P. Rimbos Vol #: 2
EMC 198 B. Rystrom Vol #: 2
EMC 199 L. and M. Seaver Vol #: 2
EMC 200 J. Daily Vol #: 2
EMC 201 M. Maisenhalter Vol #: 2
EMC 202 M. Stern Vol #: 2
EMC 203 L. Lawton Vol #: 2
EMC 204 A. Breene Vol #: 2
EMC 205 A. Savett Vol #: 2
EMC 206 C. & A. Chase Vol #: 2
EMC 207 J.F. and D.M. Williams Vol #: 2
EMC 208 S. Rekdal Vol #: 2
EMC 209 J. Gray Vol #: 2
EMC 210 J. Gray Vol #: 2
EMC 211 L. Mattingly Vol #: 2
EMC 212 C. Snyder Vol #: 2
EMC 213 Katie Richter Vol #: 2
EMC 214 J. Renton Vol #: 2
EMC 215 H. Newman Vol #: 2
EMC 216 A. Nava Vol #: 2
EMC 217 C. Smith Vol #: 2
EMC 218 D. Cobb Vol #: 2
EMC 219 G. Spates Vol #: 2
EMC 220 P. Tuff Vol #: 2
EMC 221 Jack M. Vol #: 2
EMC 222 G. Robinson Vol #: 2
EMC 223 P. Lipari Vol #: 2
EMC 224 D. Addison Vol #: 2
EMC 225 J. Clarke Vol #: 2
EMC 226 D. Faciane Vol #: 2
EMC 227 R. Marshall Vol #: 2
EMC 228 T. Troy Vol #: 2
EMC 229 S. Panek Vol #: 2
EMC 230 J. Messner Vol #: 2
EMC 231 V. Misra Vol #: 2
EMC 232 L. Nadeau Vol #: 2
EMC 233 J. I. Hill Vol #: 2
EMC 234 G. Adams Vol #: 2
EMC 235 L. Borst Vol #: 2
EMC 236 R. Domino Vol #: 2
EMC 237 M. Baker Vol #: 2
EMC 238 C. Galka Vol #: 2
EMC 239 M. Mayo Vol #: 2
EMC 240 P. Beves Vol #: 2
EMC 241 D. Round Vol #: 2
EMC 242 K. Hanzel Vol #: 2
EMC 243 K. Brown Vol #: 6
EMC 244 J. Sugiyama Vol #: 2
EMC 245 L. Parker Vol #: 2
EMC 246 A. Scheid Vol #: 2
EMC 247 J. West Vol #: 2
EMC 248 M. Stock Vol #: 2
EMC 249 W. Elton Vol #: 2
EMC 250 E. Parker Vol #: 2
EMC 251 J. Olson Vol #: 2
EMC 252 P. Tomlinson, Jr. Vol #: 2
EMC 253 R. Backman Vol #: 2
EMC 254 B. Hall Vol #: 2
EMC 255 V. Brady Vol #: 2
EMC 256 M. Strawn Vol #: 2
EMC 257 C. Kroehler Vol #: 2
EMC 258 T. O'Neil Vol #: 2
EMC 259 K. Sanchez Vol #: 2
EMC 260 K. Kuehlwein Vol #: 2
EMC 261 K. Zach Vol #: 2
EMC 262 E. Kendrick Vol #: 2
EMC 263 M. Thompson Vol #: 2
EMC 264 J. Tapy Vol #: 2
EMC 265 T. Raia Vol #: 2
EMC 266 S. Harrigan Vol #: 2
2004N-0087 Request for Comment on Generic Drug Issues
EMC 1 B. Sachau Vol #: 1
2004P-0105 Nutrient Content Claim: Total Carbohydrate Content of Foods
ACK 1 HFS-255 to Kraft Foods North America Inc Vol #: 1
CP 1
Attachment 1, 2
Kraft Foods North America Inc Vol #: 1
MM 1 FDA, USDA, Kraft Foods North America Inc Vol #: 1
2004P-0107 Nutrient Content Claim: Carbohydrate Content of Foods
ACK 1 HFS-800 to ConAgra Foods Vol #: 1
CP 1 ConAgra Foods Vol #: 1
2004P-0110 Nutrient Content Claim: Carbohydrate Content of Foods
ACK 1 HFS-800 to A Kretser, Grocery Manufacturers of America Vol #: 1
ACK 2 HFS-800 to J Skiles, Grocery Manufacturers of America Vol #: 1
CP 1
Attachment
Grocery Manufacturers of America Vol #: 1

Page created on March 12, 2004 dp
Page updated on March 22, 2004 jb

horizonal rule

Dockets Home| Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility

FDA/Dockets Management