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 April 2, 2007
Docket # Title
1993P-0346 Butalbital, Acetaminophen, Caffeine and Hydrocodone
1998N-0337C Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003E-0256 Patent Extension for Ranexa (ranolazine), 4,567,264
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0573 Draft Animal Cloning Risk Assessment
2003P-0064 Withhold Approval of Generic Lovenox (enoxaparin sodium inje
2004P-0262 Withdraw approval of ANDA suitability petition
2005E-0245 Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005P-0121 Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
2006D-0504 Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices
2006P-0255 discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0402 FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)
2006P-0405 Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
2007N-0015 Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
2007N-0051 Safety of Fresh Produce; Public Hearings
2007P-0126 Amend Existing Regulation for Strength from 4.0-90 mci/mL to 0.0-475 mci/mL Concerning NDA 20-306 (Fludeoxyglucose F 18 Injection)
2007P-0127 Determine that any versions of tramadol for once-daily dosing will not be approved prior to expiration of three-year period of exclusivity for Ultram ER
1993P-0346 Butalbital, Acetaminophen, Caffeine and Hydrocodone
PAV 2 FDA/CDER to King & Spalding LLP Vol #: 1
1998N-0337C Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
C 1 CTFA, Cosmetic, Toiletry and Fragrance Association Vol #: 1
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1340 N. Spence Vol #: 6
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 786 Mission Possible International Vol #: 10
EMC 787 Mission Possible International Vol #: 10
EMC 788 Mission Possible International Vol #: 10
2003E-0256 Patent Extension for Ranexa (ranolazine), 4,567,264
N 1 FDA Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1465 C. Radlo Vol #: 12
EMC 1466 P. Hancock Vol #: 5
2003N-0573 Draft Animal Cloning Risk Assessment
EC 4085 Ms. becca hellings Vol #: 22
EC 4086 Mr. David Allen Vol #: 22
EC 4087 Mrs. Pauline Rosa-Martir Schepper Vol #: 22
EC 4088 Miss. aimee cordero Vol #: 22
EC 4089 Mr. William Wood Vol #: 22
EC 4090 Mr. Anthony King Vol #: 22
EC 4091 Ms. Diana Pryntz Vol #: 22
EC 4092 Mrs. Eleanor Peevler Vol #: 22
EC 4093 Ms. Renee Antaya Vol #: 22
EC 4094 Ms. Christine Caldara Piatos Vol #: 22
EC 4095 Ms. Catherine White Vol #: 22
EC 4096 Ms. Ramona Lee Vol #: 22
EC 4097 Mr. John Rasmussen Vol #: 22
EC 4098 Mr. Andrew McGavisk Vol #: 22
EC 4099 Ms. Tina Patel Vol #: 22
EC 4100 Mrs. Lee Ann Reinfeldt Vol #: 22
EC 4101 Ms. Emily Bragonier Vol #: 22
EC 4102 Mr. Jack Chapman Vol #: 22
EC 4103 Mrs. Sheila Hammond Vol #: 22
EC 4104 Mr. Andy Jung Vol #: 22
EC 4105 Ms. Liz Richards Vol #: 22
EC 4106 Ms. Melissa Lemke Vol #: 22
EC 4107 University of Texas at Austin Vol #: 22
EC 4108 Mrs. Laura Lubin Vol #: 22
EC 4109 Miss. Katrina Robb Vol #: 22
EC 4110 Mrs. Dani Furr Vol #: 22
EC 4111 Ms. Julia King Vol #: 22
EC 4112 Mrs. Regina Lewis Vol #: 22
EC 4113 Miss. Denise L. Shipley Vol #: 22
EC 4114 Mrs. Cheryl Fala Vol #: 22
EC 4115 Mrs. Xeniia Sales Vol #: 22
EC 4116 Ms. Barbara Savoia Vol #: 22
EC 4117 Miss. Jesse Holt Vol #: 22
EC 4118 Mrs. Roxanne Acosta Vol #: 22
EC 4119 Mrs. Brenda Simon Vol #: 22
EC 4120 Mr. Shane Stewart Vol #: 22
EC 4121 Ancient Heritage Ranch Vol #: 22
EC 4122 Mr. Shawn Wozniak Vol #: 22
EC 4123 Mr. Emmett Toombs Vol #: 22
EC 4124 Mr. dogan ozkan Vol #: 22
EC 4125 Mrs. alicia rutkoski Vol #: 22
EC 4126 Mrs. carol rogers Vol #: 22
EC 4127 Ms. Laurel Mancini Vol #: 22
EC 4128 Ms. Sandra Drake Vol #: 22
EC 4129 Mrs. Crystal Roden Vol #: 22
EC 4130 Mr. William McMullin Vol #: 22
EC 4131 Mr. Eric Galbreath Vol #: 22
EC 4132 Mrs. Niquia Spencer Vol #: 22
EC 4133 fred meyer Vol #: 22
EC 4134 PEOPLE FOR ANIMALS HARYANA, www.pfaharyana.in Vol #: 22
EC 4135 Ms. Claudia Camacho Vol #: 22
EC 4136 Miss. leszeth ocampo Vol #: 22
EC 4137 Ms. Debbie Burack Vol #: 22
EC 4138 Citizan of the Earth Vol #: 22
EC 4139 Mr. Brian Smith Vol #: 22
EC 4140 Ms. Margaret Rydant Vol #: 22
EC 4141 Mrs. Denise Patterson-Monroe Vol #: 22
EC 4142 (none) Vol #: 22
EC 4143 Mrs. Janette Morrell Vol #: 22
EC 4144 Mrs. Cheryl Cristini Vol #: 22
EC 4145 Ms. Cynthia Brine Vol #: 22
EC 4146 Mr. Michael Loveless Vol #: 22
EC 4147 Miss. frederique sol Vol #: 22
EC 4148 Mr. Eric L Brown Sr Vol #: 22
EC 4149 Miss. Savanna Cashion Vol #: 22
EC 4150 Dr. Michael Yannell Vol #: 22
EC 4151 Miss. jill kuzman Vol #: 22
EC 4152 Mr. Eric Hutcheson Vol #: 22
EC 4153 Ms. dolores boland Vol #: 22
EC 4154 Mr. Mark Smith Vol #: 22
EC 4155 Ms. Tracey Kehler Vol #: 22
EC 4156 Ms. mary burton riseley Vol #: 22
EC 4157 Miss. Julie Yapp Vol #: 22
EC 4158 Ms. LaVerne Braxton Vol #: 22
EC 4159 Ms. Lisa Dominguez Vol #: 22
EC 4160 Ms. Wendy Matusovich Vol #: 22
EC 4161 Mrs. Amy Hughes Vol #: 22
EC 4162 Mr. jamey branum Vol #: 22
EC 4163 Mr. Ricky Sprague Vol #: 22
EC 4164 Ms. Larkin Gieringer Vol #: 22
EC 4165 Mrs. MARY HOPE MUELLER Vol #: 22
EC 4166 Mr. Casey Gwinn Vol #: 22
EC 4167 Mr. Brett Renville Vol #: 22
EC 4168 Mrs. Judith Deal Vol #: 22
EC 4169 Miss. Tammy Cox Vol #: 22
EC 4170 Mr. Richard Staggs Vol #: 22
EC 4171 Mrs. Andrea Nanna-Montgomery Vol #: 22
EC 4172 Mr. Jeffrey Smith Vol #: 22
EC 4173 Eat Outside the Box Vol #: 22
EC 4174 Mr. Aaron Winter Vol #: 22
EC 4175 Mrs. Rose Reed Vol #: 22
EC 4176 Mrs. Megan Bell Vol #: 22
EC 4177 Mr. James Bussacco Vol #: 22
EC 4178 Ms. Monica Rupp Vol #: 22
EC 4179 Miss. sarah stredny Vol #: 22
EC 4180 Souza Sound Video company Vol #: 22
EC 4181 Mrs. Leslie Freeland Vol #: 22
EC 4182 Mrs. Bonnie Lemonds Vol #: 22
EC 4183 Ms. Al Bonvouloir Vol #: 22
EC 4184 Mrs. Sandra Reed Vol #: 22
EC 4185 the garden restaurant, redwoods restaurant Vol #: 22
EC 4186 self Vol #: 22
EC 4187 Mr. Eric Bourgeois Vol #: 22
EC 4188 Mr. alex weiland Vol #: 22
EC 4189 Good Earth Gourmet Market Vol #: 22
EC 4190 Ms. Carla Loosier Vol #: 22
EC 4191 Mr. Sander Kerkhoffs Vol #: 22
EC 4192 Ms. Sarah Sullenberger Vol #: 22
EC 4193 Mrs. Rebekah Rector Vol #: 22
EC 4194 Mr. Lonnie Mauck Vol #: 22
EC 4195 Ms. coleen hulse Vol #: 22
EC 4196 Mrs. Heidi Ziehm Vol #: 22
EC 4197 Ms. Mary Rushing Vol #: 22
EC 4198 New Fulton Fish Market Vol #: 22
EC 4199 Mr. Joseph Grecco Vol #: 22
EC 4200 Ms. Carolyn Scott Vol #: 22
EMC 153 P. Kupperman Vol #: 5
EMC 154 T. Nuccio Vol #: 5
2003P-0064 Withhold Approval of Generic Lovenox (enoxaparin sodium inje
EMC 2 Campbell University School of Pharmacy Vol #: 6
2004P-0262 Withdraw approval of ANDA suitability petition
PAV 1 FDA/CDER to King & Spalding LLP Vol #: 1
2005E-0245 Patent Extension Application for KEPIVANCE (palifermin), U.S. Patent No. 5,677,278
N 1 FDA Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EREG 52 M. Spencer Vol #: 32
2005P-0121 Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
C 14 The Cleveland Clinic Foundation Vol #: 7
2006D-0504 Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices
C 2 Medtronic Inc Vol #: 1
C 3 Boston Scientific Corporation (BSC), Guidance Corporation Vol #: 1
C 4 Medical Products Group, Abbott Laboratories Vol #: 1
C 5 IDM, a Haemonetics Company Vol #: 1
EC 2 Mr. Edward Karst Vol #: 1
EC 3 IEEE 11073 RF Wireless SC Vol #: 1
EC 4 LifeSync Corporation Vol #: 1
EC 5 Olsson, Frank Vol #: 1
EC 6 Philips Medical Systems Vol #: 1
2006P-0255 discontinued formulation of Warner Chilcott's Duricel (cefadroxil) tablets 1 g was not discontinued for safety and efficacy reasons
ANS 1 FDA/CDER to Orchid Healthcare Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 77 K Smith Vol #: 7
C 78 S Martin Vol #: 7
EMC 22 Animal Welfare Institute Vol #: 3
2006P-0402 FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)
C 1 Hyman, Phelps & McNamara PC Vol #: 1
EC 1 Dr. Ken Bloom Vol #: 1
EC 2 Hyman, Phelps Vol #: 1
2006P-0405 Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
EMC 1 S. Dickens Vol #: 2
2007N-0015 Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the FDA Food Code by Local, State, and Tribal Governments
EMC 1 Center for Science in the Public Interest Vol #: 1
2007N-0051 Safety of Fresh Produce; Public Hearings
C 1 The Ocean Conservancy Vol #: 1
C 2 California Regional Water Quality Control Board Vol #: 1
C 3 U S Environmental Protection Agency Vol #: 1
C 4 U S Department of Commerce, NOAA Vol #: 1
C 5 U S Department of Commerce, NOAA Vol #: 1
C 6 L Moffat Vol #: 1
EC 1 Owner-Operator Independent Drivers Association Vol #: 1
EC 2 Mr. Steven Ackerman Vol #: 1
EC 3 Mr. Ron Strochlic Vol #: 1
2007P-0126 Amend Existing Regulation for Strength from 4.0-90 mci/mL to 0.0-475 mci/mL Concerning NDA 20-306 (Fludeoxyglucose F 18 Injection)
ACK 1 FDA/ DDM to PFI LLC Vol #: 1
CP 1 PFI LLC Vol #: 1
2007P-0127 Determine that any versions of tramadol for once-daily dosing will not be approved prior to expiration of three-year period of exclusivity for Ultram ER
ACK 1 FDA/DDM to Ropes & Gray LLP Vol #: 1
CP 1 Ortho-McNeil, Inc. Vol #: 1

Page created on April 3, 2007 ue

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