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Dockets Entered On April 5, 2006
Table of Contents
Docket # Title
1978N-0036L OTC Laxative
1981N-0033 Oral Health Care Drug Products for OTC Human Use
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
1999V-4395 Laser Light Show
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
2000V-1576 AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
2004P-0206 No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies
2004P-0522 Off label drug use for CYTOTEC
2004P-0557 ANDA for a generic version of Efudex Cream(fluorouracil) cream
2005N-0285 Current Good Manufacturing Practice Regulation and Investigational New Drugs
2005P-0242 ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
2005P-0377 Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2005V-0198 Projector for a Laser Light Show
2006D-0017 Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents
2006D-0044 Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
2006D-0066 Guidance for Industry and FDA Staff: Whole Grains Label Statements
2006E-0003 Patent Extension Application for BiDIL (combination of hydralazine hydrochloride and isosorbide dinitrate), U.S. Patent No. 4,868,179
2006E-0004 Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
2006E-0042 Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
2006N-0019 Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
2006P-0070 Misbranding of generic azithromycin products marketed by Teva Pharmaceuticals USA and Sandoz Inc.
2006P-0084 ANDA Suitability for 1.25 mg, 2.50 mg, 5 mg, and 10 mg Ramipril Tablets
2006P-0092 Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded
2006P-0094 To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
2006P-0098 Seeks a determination that Loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA based on the reference listed drug loperamide hydrochloride 2 mg oral chewable tablet (Imo
2006P-0101 Petition for Review of Codex Standard for Honey Under 21 CFR 130.6
2006P-0102 Take appropriate remedial action relating to an apparent safety issue regarding Bellatal ER
2006P-0103 ANDA Suitability for Temazepam Orally Disintegrating Tablets, 7.5 mg, 15 mg, 22.5 mg, and 30 mg
2006P-0125 Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons
1978N-0036L OTC Laxative
C 215 D. Lowe Vol #: 138
1981N-0033 Oral Health Care Drug Products for OTC Human Use
ACK 7 HFA-305 to the Procter & Gamble Company Vol #: 75
CP 6 The Procter & Gamble Company Vol #: 75
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 17512 FoodScience Corporation Vol #: 161
LET 17513 Doctor's Best, Inc. Vol #: 161
LET 17514 Ajinomoto USA, Inc. Vol #: 161
LET 17515 Ajinomoto USA, Inc. Vol #: 161
LET 17516 Sedona Labs, Inc. Vol #: 161
LET 17517 Bayer HealthCare Consumer Care Division Vol #: 161
LET 17518 Bayer HealthCare Consumer Care Division Vol #: 161
LET 17519 New Century Company Vol #: 161
LET 17520 NDS Nutritional Products, Inc. Vol #: 161
LET 17521 Nu Science Labs, Inc. Vol #: 161
LET 17522 Michael's Naturopathic Programs Vol #: 161
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7528 D. Schulte Vol #: 320
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 18259 B. Sullivan Vol #: 516
C 18260 R. Miller Vol #: 516
1999V-4395 Laser Light Show
VRA 2 HFZ-200 to Lightwave Laser Productions Vol #: 1
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 12852 R. Miller Vol #: 806
C 12853 B. Sullivan Vol #: 806
2000V-1576 AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light
VRA 6 HFZ-200 to Insight Technology Incorporated Vol #: 1
2001P-0230 Domestic Marketing & Importation of Transgenic Fish
C 1375 R. Miller Vol #: 259
C 1376 B. Sullivan Vol #: 259
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 244 No signature Vol #: 4
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 624 Mission Possible International Vol #: 9
EMC 625 Mission Possible International Vol #: 9
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1260 No signature Vol #: 12
EMC 1261 No signature Vol #: 12
EMC 1262 C. Lahay Vol #: 12
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
C 54 R. Miller Vol #: 5
2004P-0206 No abbreviated new drug application (ANDA) for Fluticasone Propionate Nasel Spray will be approval, unless it contains bioavailability and bioequivalence studies
C 3 D. Lowe Vol #: 1
2004P-0522 Off label drug use for CYTOTEC
SUP 2 The Tatia Oden French Memorial Foundation Vol #: 1
2004P-0557 ANDA for a generic version of Efudex Cream(fluorouracil) cream
RC 2 Valeant Pharmaceuticals International Vol #: 3
2005N-0285 Current Good Manufacturing Practice Regulation and Investigational New Drugs
C 6 Cambrex Vol #: 1
C 7 Immel Resource LLC Vol #: 1
EC 2 Mr. Denish Moorthy Vol #: 1
EC 3 PDA Vol #: 1
EC 4 Immel Resources LLC Vol #: 1
EC 5 Novartis Pharmaceuticals Corp. Vol #: 1
EC 6 Public Citizen's Health Research Group Vol #: 1
2005P-0242 ANDA for a sterile Vancomycin Hydrochloirde,USP bulk package in 100 gram dosage strength in plasti bags
C 2 D. Lowe Vol #: 1
2005P-0377 Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
SUP 9 Department of the Planet Earth Vol #: 3
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EC 29978 Ms. Linda Meyer Vol #: 0
EC 29979 Miss. Lisa Bennett Vol #: 0
EC 29980 Ms. Kim Butler Vol #: 0
EC 29981 Mrs. Paula Sue Clifton Vol #: 0
EC 29982 Mrs. SUSAN BRENARD Vol #: 0
EC 29983 Ms. Allyson Clawson Vol #: 0
EC 29984 Mrs. C.S. Perrio Vol #: 0
EC 29985 Mr. Elmer Burk Vol #: 0
EC 29986 Mrs. Deborah Zick Vol #: 0
EC 29987 Ms. Sharon Crook Vol #: 0
EC 29988 Ms. Lisa Hoffman Vol #: 0
EC 29989 Mrs. Mary Bezotte Vol #: 0
EC 29990 Mr. Jeff Brown Vol #: 0
EC 29991 Mr. Randy Preston Vol #: 0
EC 29992 Standard Process.com Vol #: 0
EC 29993 Mrs. Janet Cook Vol #: 0
EC 29994 Ms. Dianna Avants Vol #: 0
EC 29995 Mrs. Lori Burns Vol #: 0
EC 29996 Ms. ioana hagiu Vol #: 0
EC 29997 Mrs. Kristin Johnson Vol #: 0
EC 29998 Mrs. Jean McEntire Vol #: 0
EC 29999 Mr. Danny J. Ament Vol #: 0
EC 30000 Ms. Geena Gador Vol #: 0
EC 30001 Ms. Erica Kelley Vol #: 0
EC 30002 Mrs. Arline Gates Vol #: 0
EC 30003 Ms. Darlene Mitchell Vol #: 0
EC 30004 Mr. Brian Rosenbeck Vol #: 0
EC 30005 Mrs. Shirley Trowbridge Vol #: 0
EC 30006 Mrs. Mechelle Hutchinson Vol #: 0
EC 30007 Ms. Barbara Newberry Vol #: 0
EC 30008 Miss. Kelly Patredis Vol #: 0
EC 30009 Mrs. Pixie Baxter Vol #: 0
EC 30010 Mrs. Jill Laufer Vol #: 0
EC 30011 Mrs. Ann Karcich Vol #: 0
EC 30012 Dr. Linda Eisen Vol #: 0
EC 30013 Mr. Kenneth Karcich Vol #: 0
EC 30014 Full-Body Fitness Vol #: 0
EC 30015 Mrs. Loretta Peterson Vol #: 0
EC 30016 Mrs. Rebecca Bromley Vol #: 0
EC 30017 American Holistic Nurses' Association Vol #: 0
EC 30018 Mrs. Jennifer Little Vol #: 0
EC 30019 Dr. Michael Schachter Vol #: 0
EC 30020 Mrs. Mary Shields Vol #: 0
EC 30021 Mrs. Martha Taylor Vol #: 0
EC 30022 Mrs. Brenda Gravitt Vol #: 0
EC 30023 Ms. Rebecca Hughes Vol #: 0
EC 30024 Ms. Sue Sims Vol #: 0
EC 30025 Mrs. Vondell Stroud Vol #: 0
EC 30026 Ms. Sally Rogers Vol #: 0
EC 30027 Mrs. Esther Thomas Vol #: 0
EC 30028 Ms. Debora Foor Vol #: 0
EC 30029 Mrs. Darleen Somley Vol #: 0
EC 30030 Mrs. Kathy Veer Vol #: 0
EC 30031 Ms. Karen Hall Vol #: 0
EC 30032 Ms. laura campbell Vol #: 0
EC 30033 Mr. Tony Sansone Vol #: 0
EC 30034 Mrs. Elva Chambers Vol #: 0
EC 30035 Ms. Shirley Worley Vol #: 0
EC 30036 Mrs. Margaret Humphreys Vol #: 0
EC 30037 Mr. Edwin Ouwerkerk Vol #: 0
EC 30038 Ms. Lisa Pitcher Vol #: 0
EC 30039 Ms. Bonnie Norman Vol #: 0
EC 30040 Ms. Marilyn Sims Vol #: 0
EC 30041 Mrs. Suzanne Smith Vol #: 0
EC 30042 Mrs. Louise McDermott Vol #: 0
EC 30043 Ms. Eileen Chambers Vol #: 0
EC 30044 Mrs. Leona Knight Vol #: 0
EC 30045 Mr. Horace Knight Vol #: 0
EC 30046 Mr. Jeffrey Smith Vol #: 0
EC 30047 Mrs. Joyce Yoder Vol #: 0
EC 30048 Ms. Mary Rager Vol #: 0
EC 30049 n/a Vol #: 0
EC 30050 Moffitt Cancer Center Vol #: 0
EC 30051 Mrs. Mary Spielberg Vol #: 0
EC 30052 Mrs. Juliann Dawson Vol #: 0
EC 30053 Mrs. Carrie Emmons Vol #: 0
EC 30054 Mrs. Luisa DiPietro Vol #: 0
EC 30055 Mrs. Susan Tannehill Vol #: 0
EC 30056 Dr. Amal Madani Vol #: 0
EC 30057 Mr. Clive Linsenbardt Vol #: 0
EC 30058 Mrs. Melissa Waldrop Vol #: 0
EC 30059 Ms. Sonja De Herdt Vol #: 0
EC 30060 Ms. Christine Morrison Vol #: 0
EC 30061 Ms. D Winter Vol #: 0
EC 30062 Mrs. Constance Dalmau Vol #: 0
EC 30063 Mrs. Lisa Pongnon Vol #: 0
EC 30064 Ms. Megan George Vol #: 0
EC 30065 Mrs. Maria Quinones Vol #: 0
EC 30066 Ms. Christine Braunger Vol #: 0
EC 30067 Mrs. Anne Rampone Vol #: 0
EC 30068 Ms. Sherry Oliphant Vol #: 0
EC 30069 Mrs. Rita Meade Vol #: 0
EC 30070 Mrs. Tanya Duncanson Vol #: 0
EC 30071 Mrs. Melanie Lequia Vol #: 0
EC 30072 Mrs. Veronica Warson Vol #: 0
EC 30073 Ms. Susan Thompson Vol #: 0
EC 30074 Mr. John Kranick Vol #: 0
EC 30075 Mr. Bill Buehne Vol #: 0
EC 30076 Ms. Jennifer Walter Vol #: 0
EC 30077 Mrs. Teri Tregoning Vol #: 0
EC 30078 consumer Vol #: 0
EC 30079 Ms. Sheryl Cleverley Vol #: 0
EC 30080 Resources West Inc. Vol #: 0
EC 30081 none Vol #: 0
EC 30082 Ms. Vera Graaf Vol #: 0
EC 30083 Tax Payer Vol #: 0
EC 30084 Ms. nancy pelan Vol #: 0
EC 30085 Mrs. Mitzi Surbaugh Vol #: 0
EC 30086 Mrs. denise codgen Vol #: 0
EC 30087 Mrs. Alice White Vol #: 0
EC 30088 Ms. Claudia Purdom Vol #: 0
EC 30089 Ms. Catherine Quanrud Vol #: 0
EC 30090 Mrs. Sheryl Wagoner Vol #: 0
EC 30091 Mrs. Jami Marr Vol #: 0
EC 30092 Miss. Denise Easterbrooks Vol #: 0
EC 30093 Mr. martin good Vol #: 0
EC 30094 Ms. Danielle Acosta Vol #: 0
EC 30095 Mrs. Martha Ford Vol #: 0
EC 30096 Ms. Heather Swinea Vol #: 0
EC 30097 Mrs. Terri Ackely Vol #: 0
EC 30098 Mrs. Patricia Teston Vol #: 0
EC 30099 Mrs. Josha Epp Vol #: 0
EC 30100 Mr. Fred Wooten Vol #: 0
EC 30101 Mrs. Linda Breining Vol #: 0
EC 30102 Dr. Robert James Robertson Vol #: 0
EC 30103 Mrs. Johnette van Eeden Vol #: 0
EC 30104 Mrs. L Frank Vol #: 0
EC 30105 Ms. Meryl Toan Vol #: 0
EC 30106 Mrs. Karen Michael Vol #: 0
EC 30107 Ms. Rebecca James Vol #: 0
EC 30108 Ms. Terri Elliott Vol #: 0
EC 30109 Ms. beverly austin Vol #: 0
EC 30110 Mrs. Susan Robertson Vol #: 0
EC 30111 Ms. Shawn Riley Vol #: 0
EC 30112 Ms. elle walters Vol #: 0
EC 30113 Miss. V Hall Vol #: 0
EC 30114 Ms. Rima Phillips Vol #: 0
EC 30115 Ms. deborah mcgovern Vol #: 0
EC 30116 Ms. Patty Love Vol #: 0
EC 30117 Mrs. Debra Richards Vol #: 0
EC 30118 Mrs. Leona Mickelson Vol #: 0
EC 30119 Ms. Mary Ann Bouse Vol #: 0
EC 30120 Mrs. Jean Ames Vol #: 0
EC 30121 Mrs. Mary Counts Vol #: 0
EC 30122 Ms. Caroline Chamberlain Vol #: 0
EC 30123 Mrs. Monica Kelley Vol #: 0
EC 30124 Mrs. Mary Ann Hartzler Vol #: 0
EC 30125 Ms. Paige Ryan Vol #: 0
EC 30126 Mrs. Crystal Deyoung Vol #: 0
EC 30127 Mrs. Mary Gaumer Vol #: 0
EC 30128 Miss. karen cox Vol #: 0
EC 30129 Ms. Sonia Stovall Vol #: 0
EC 30130 Mrs. Debbie Best Vol #: 0
EC 30131 Mrs. Gloria Lattimer Vol #: 0
EC 30132 Mrs. Mary Samford Vol #: 0
EC 30133 Mrs. Sara Sheets Vol #: 0
EC 30134 Columbia University Vol #: 0
EC 30135 Mrs. Cristine Nielsen Vol #: 0
EC 30136 Mrs. Debbie Mackintosh Vol #: 0
EC 30137 Ms. Anne Nichting Vol #: 0
EC 30138 Miss. Catherine Reagan Vol #: 0
EC 30139 Ms. Pam Zulovich Vol #: 0
EC 30140 Mrs. Diane Hayden Vol #: 0
EC 30141 Ms. Kathleen O'Farrell Vol #: 0
EC 30142 Ms. Holly Rittenhouse Vol #: 0
EC 30143 Ms. MARTHA ZUCKERMAN Vol #: 0
EC 30144 Ms. Donna Church Vol #: 0
EC 30145 Mrs. Corene Finley Vol #: 0
EC 30146 Miss. Karen Woodcock Vol #: 0
EC 30147 Ms. f cee Vol #: 0
EC 30148 Ms. Sandra Peterson Vol #: 0
EC 30149 Mrs. Marilyn Eales Vol #: 0
EC 30150 Ms. Stephanie Davie Vol #: 0
EC 30151 Holistic Nursing Service Vol #: 0
EC 30152 Ms. carol kurtz Vol #: 0
EC 30153 Mrs. Lois Elliott Vol #: 0
EC 30154 Ms. Diane watts Vol #: 0
EC 30155 Dr. charlie armstrong Vol #: 0
EC 30156 Mrs. Carol Jeffrey Vol #: 0
EC 30157 Mrs. Elizabeth Dela Cruz Vol #: 0
EC 30158 Mrs. Beverly Sloofman Vol #: 0
EC 30159 Mrs. Shaaron Freeburg Vol #: 0
EC 30160 Dr. Bruce Shelton MD MD(h) Vol #: 0
EC 30161 Ms. cynthia schaap Vol #: 0
EC 30162 alternative health consumer-individual Vol #: 0
EC 30163 Mrs. Marisa Covello Vol #: 0
EC 30164 Mrs. Ginger Goslin Vol #: 0
EC 30165 Mrs. Gail Anderson Vol #: 0
EC 30166 Mrs. Peggy LaRochelle Vol #: 0
EC 30167 Mrs. Dana Weber Vol #: 0
EC 30168 Mrs. Katherine Grether Vol #: 0
EC 30169 Ms. Alana Olson Vol #: 0
EC 30170 Miss. Pina Di Pasquale Vol #: 0
EC 30171 Ms. Terry Anderson Vol #: 0
EC 30172 Mrs. Beran Black Vol #: 0
EC 30173 n/a Vol #: 0
EC 30174 Private Citizen Vol #: 0
EC 30175 Northern Maine Medical Center Vol #: 0
EC 30176 Mrs. rachel darnell-heath Vol #: 0
EC 30177 Mrs. Donna Arnold Vol #: 0
EC 30178 Ms. Carol St. Jean Vol #: 0
EC 30179 Mrs. sharon strange Vol #: 0
EC 30180 Mrs. Faye Berkowitz Vol #: 0
EC 30181 Mrs. Leeta von Buelow Vol #: 0
EC 30182 Ms. Janice Marshall Vol #: 0
EC 30183 Mrs. Jennifer Babisak Vol #: 0
EC 30184 Ms. Anna Harrington Vol #: 0
EC 30185 Ms. Carol Vivion Vol #: 0
EC 30186 Pivotal Health LLC Vol #: 0
EC 30187 Health 2 U Vol #: 0
EC 30188 Ms. Audrey Bryant Vol #: 0
EC 30189 Ms. Karen Yore Vol #: 0
EC 30190 Mrs. Kimberly Kwekel Vol #: 0
EC 30191 Mrs. Rosemary White Vol #: 0
EC 30192 Mrs. Wanda Ivey Vol #: 0
EC 30193 Mrs. Candi Pilo Vol #: 0
EC 30194 Ms. Kathy Zeltmann Vol #: 0
EC 30195 Mrs. Bridget Fitzgerald Vol #: 0
EC 30196 Mrs. Sherry Van Pelt Vol #: 0
EC 30197 Mr. Clair White Vol #: 0
EC 30198 Ms. Nancy Gerzon Vol #: 0
EC 30199 Mrs. Diana Goeden Vol #: 0
EC 30200 Mrs. Lynne Brown Vol #: 0
EC 30201 Mrs. Haven Howard Vol #: 0
EC 30202 Mrs. Debbie Komer Vol #: 0
EC 30203 Mrs. Cynthia Strehlow Vol #: 0
EC 30204 Mrs. Elaine Hager Vol #: 0
EC 30205 Ms. Patricia Faulkner Vol #: 0
EC 30206 Mrs. Melinda Schroeder Vol #: 0
EC 30207 Mrs. Lisa Cox Vol #: 0
EC 30208 Dr. Lance Durrett Vol #: 0
EC 30209 Mr. robert bartlett Vol #: 0
EC 30210 Mrs. Linda Dew Vol #: 0
EC 30211 Mrs. Kathryn Conner Vol #: 0
EC 30212 Ms. Mary Greene Vol #: 0
EC 30213 ada,aacd,agd,aapd,aos, Vol #: 0
EC 30214 Mr. Malcolm Carroll Vol #: 0
EC 30215 Mrs. CONSTANCE CHANEY Vol #: 0
EC 30216 Mrs. Karen Johnson Vol #: 0
EC 30217 Mrs. V. Bartels Vol #: 0
EC 30218 Mrs. Leah Edelstein Vol #: 0
EC 30219 Mrs. Roxanne Bassett Vol #: 0
EC 30220 Mrs. Rina Caldwell Vol #: 0
EC 30221 Ms. Annette Chval Vol #: 0
EC 30222 Ms. Shirley Machonis Vol #: 0
EC 30223 Mrs. Angela Carp Vol #: 0
EC 30224 Mrs. Lindy Sullivan Vol #: 0
EC 30225 Mrs. Bonnie Rose Vol #: 0
EC 30226 Mrs. Cynthia Bahr Vol #: 0
EC 30227 Mrs. Dorothy Stevens Vol #: 0
EC 30228 Mr. Richard Trent Vol #: 0
EC 30229 Miss. Alicia Kereczman Vol #: 0
EC 30230 Mr. John E Jacobus Jr Vol #: 0
EC 30231 Mrs. Susan Spear Vol #: 0
EC 30232 Living Dreams Inc Vol #: 0
EC 30233 Ms. Janet Szabo Vol #: 0
EC 30234 Mrs. Brenda Kell Vol #: 0
EC 30235 Mrs. Lois Kuck Vol #: 0
EC 30236 Dr. Robert Morrison Vol #: 0
EC 30237 Ms. Jannae DeAngelo Vol #: 0
EC 30238 Mrs. Sharla Carver Vol #: 0
EC 30239 Ms. Penny Carter Vol #: 0
EC 30240 Brookings Harbor School District Vol #: 0
EC 30241 Mrs. Ann Huppert Vol #: 0
EC 30242 Dr. Mohsin Syed Vol #: 0
EC 30243 Dr. Diana Cook Vol #: 0
EC 30244 Mrs. K Kohler Vol #: 0
EC 30245 Miss. Patricia Wade Vol #: 0
EC 30246 Mrs. Mary Jo Boven Vol #: 0
EC 30247 Ms. Lori Pujol Vol #: 0
EC 30248 Mrs. Tammy Greenwood Vol #: 0
EC 30249 Ms. Maureen Linquist Vol #: 0
EC 30250 Mrs. Linda Ring Vol #: 0
EC 30251 Ms. Jacalyn Gilhooley Vol #: 0
EC 30252 Ms. Susan McAdams Vol #: 0
EC 30253 Mrs. Diana Summerlin Vol #: 0
EC 30254 Mrs. Susan Sack Vol #: 0
EC 30255 Ms. Leslie Reynolds Vol #: 0
EC 30256 Mrs. Angela Katny Vol #: 0
EC 30257 Mrs. Candice Beck Vol #: 0
EC 30258 Ms. Eva Ford Vol #: 0
EC 30259 Mrs. gladys schwehr Vol #: 0
EC 30260 DISD Vol #: 0
EC 30261 Mrs. Linda Henthorn Vol #: 0
EC 30262 Randolph-Shambaugh Clinic Vol #: 0
EC 30263 Ms. Glenda Middleton Vol #: 0
EC 30264 Ms. Ramona Ochoa Vol #: 0
EC 30265 Mrs. Linda Henthorn Vol #: 0
EC 30266 Miss. KD Holy Vol #: 0
EC 30267 Mrs. Renee Holmes Vol #: 0
EC 30268 Ms. Pamela Richmond Vol #: 0
EC 30269 Miss. Charolette Mercer Vol #: 0
EC 30270 Mr. Charles Wilson Vol #: 0
EC 30271 Mrs. Nicole Kerkenbush Vol #: 0
EC 30272 Miss. Laura Gilliland Vol #: 0
EC 30273 Ms. Glenda Church Vol #: 0
EC 30274 Miss. Tish Fregia Vol #: 0
EC 30275 Mr. Mark O'Brien Vol #: 0
EC 30276 Mrs. Doris Peters Vol #: 0
EC 30277 Mrs. Linda Stovall Vol #: 0
EC 30278 Mrs. Heidi Alonzo Vol #: 0
EC 30279 Mrs. Jo DeFoor Vol #: 0
EC 30280 Mrs. Wilma Lewis Vol #: 0
EC 30281 Mrs. Cathy Ready Vol #: 0
EC 30282 Ms. Gerti Reagan Garner Vol #: 0
EC 30283 Mrs. Naomi Haycock, RN Vol #: 0
EC 30284 Mrs. GAYLE KELLER Vol #: 0
EC 30285 Mrs. Cynthia Sade-Ehrgott Vol #: 0
EC 30286 Ms. Gail Hodge Vol #: 0
EC 30287 Miss. Amanda Raster Vol #: 0
EC 30288 Ms. Carol Glebe Vol #: 0
EC 30289 MDICAL SOLUTIONS Vol #: 0
EC 30290 Mrs. CHERYL HOFFNER Vol #: 0
EC 30291 Ms. Mary Bordman Vol #: 0
EC 30292 Mrs. Deanna Finley Vol #: 0
EC 30293 Mrs. Theresa McCutcheon Vol #: 0
EC 30294 Ms. Emmy Miller Vol #: 0
EC 30295 Miss. Karen McCarthy Vol #: 0
EC 30296 Mrs. Debbie Mohamed Vol #: 0
EC 30297 Ms. Suzanne La Porte Vol #: 0
EC 30298 Miss. katrina borgstrom Vol #: 0
EC 30299 Mrs. Sarah Cadwell Vol #: 0
EC 30300 Mrs. Lisa Boots Vol #: 0
EC 30301 Ms. Sandra Otton Vol #: 0
EC 30302 Mrs. Nancy Slagle Vol #: 0
EC 30303 Mrs. Janet Jorgensen Vol #: 0
EC 30304 Ms. Nancy Kless Vol #: 0
EC 30305 none Vol #: 0
EC 30306 Mrs. Julie Burtt Vol #: 0
EC 30307 Mrs. Barbara Satkoski Vol #: 0
EC 30308 Mrs. Brenda Stroer Vol #: 0
EC 30309 Mrs. wendy beck Vol #: 0
EC 30310 Mrs. Alyce Carr Vol #: 0
EC 30311 Mrs. Cynthia Bohrer Vol #: 0
EC 30312 Mrs. Laura Schofield Vol #: 0
EC 30313 Mrs. Julie Coldeen Vol #: 0
EC 30314 Mrs. mary johnson Vol #: 0
EC 30315 none Vol #: 0
EC 30316 Housewife and mother Vol #: 0
EC 30317 Mrs. Suzanne Mitchell Vol #: 0
EC 30318 Mrs. Chris Kritchevsky Vol #: 0
EC 30319 Ms. janet ogle Vol #: 0
EC 30320 Mrs. Lynette Goslin Vol #: 0
EC 30321 Ms. Lynn Allcott Vol #: 0
EC 30322 Mrs. Abigail Steidley Vol #: 0
EC 30323 Mrs. Holly Rich Vol #: 0
EC 30324 Ms. Sharon Jones Vol #: 0
EC 30325 Mrs. Melissa Best Vol #: 0
EC 30326 Mrs. Kirsten Johnson Vol #: 0
EC 30327 Ms. Janice Carr Vol #: 0
EC 30328 Ms. Shibani Paul Vol #: 0
EC 30329 Ms. ANGELA MORRIS Vol #: 0
EC 30330 Mrs. Lynnda Van Rasmussen Vol #: 0
EC 30331 Mrs. cindy Schott Vol #: 0
EC 30332 PA Breast Cancer Coalition Vol #: 0
EC 30333 Mr. Lytt Mahone Vol #: 0
EC 30334 Ms. Edith Radtke Vol #: 0
EC 30335 Mrs. Gloria Wilford Vol #: 0
EC 30336 Ms. Mary Carlson Vol #: 0
EC 30337 Ms. Victoria Kwitek Vol #: 0
EC 30338 Ms. Carole Folliard Vol #: 0
EC 30339 Mr. John Gartner Vol #: 0
EC 30340 Ms. Beverly Brigantia Vol #: 0
EC 30341 Mrs. Linda Schwartz Vol #: 0
EC 30342 Mrs. Amy Bader Vol #: 0
EC 30343 Mrs. Valerie Tull Vol #: 0
EC 30344 Mr. Daniel Brusven Vol #: 0
EC 30345 Iowans for Informed Consent Vol #: 0
EC 30346 Mrs. Vickie Walker Vol #: 0
EC 30347 Mrs. Erika Anchors Vol #: 0
EC 30348 at Home Vol #: 0
EC 30349 Ms. Carol Poynter Vol #: 0
EC 30350 Ms. Judith Tonon Vol #: 0
EC 30351 Mrs. debra crumbaugh Vol #: 0
EC 30352 Mrs. Pamela McIntyre Vol #: 0
EC 30353 Dr. Ernest Perea Vol #: 0
EC 30354 Mr. brian gill Vol #: 0
EC 30355 Miss. Juliana Burke Rabe Vol #: 0
EC 30356 Mrs. Angela Uhlig Vol #: 0
EC 30357 Ms. kathy besecker Vol #: 0
EC 30358 Dr. Kayla Wagener Vol #: 0
EC 30359 Ms. Betty McMurrin Vol #: 0
EC 30360 Clemson University Vol #: 0
EC 30361 Ms. Debra Clark Vol #: 0
EC 30362 Ms. Kathryn Varga Vol #: 0
EC 30363 Mrs. Sandy Lundy Vol #: 0
EC 30364 Mrs. Janice Wolff Vol #: 0
EC 30365 Ms. Olga Kaczmar Vol #: 0
EC 30366 Mrs. Diane Cerveny Vol #: 0
EC 30367 Ms. karen patterson Vol #: 0
EC 30368 Dr. Mark Gordon Vol #: 0
EC 30369 Mrs. Kathleen Barhorst Vol #: 0
EC 30370 Ms. Lucia Turner Vol #: 0
EC 30371 Mrs. wilma robinson Vol #: 0
EC 30372 Ms. Carol marshall Vol #: 0
EC 30373 Mrs. Kathy Patredis Vol #: 0
EC 30374 Mr. Larry Armstrong Vol #: 0
EC 30375 Mr. Virgil Nabity Vol #: 0
EC 30376 Private Citizen Vol #: 0
EC 30377 Ms. Robin Tjiong Vol #: 0
EC 30378 Ms. Jayne Young Vol #: 0
EC 30379 Mrs. patricia wyborski Vol #: 0
EC 30380 Mrs. Jenine Marczewski Vol #: 0
EC 30381 Mrs. Kathy Heflin Vol #: 0
EC 30382 Mrs. Patricia Salvatore Vol #: 0
EC 30383 Nutrition, Connection, Balance, LLC Vol #: 0
EC 30384 Private Citizen Vol #: 0
EC 30385 Ms. sherry guenther Vol #: 0
EC 30386 Ms. Melanie Krueger Vol #: 0
EC 30387 Mrs. Darlene George Vol #: 0
EC 30388 Mrs. R. Olsen Vol #: 0
EC 30389 TRAVELWORLD Vol #: 0
EC 30390 Ms. Lee Ann Burgess Vol #: 0
EC 30391 Mrs. Sabina Garrisin Vol #: 0
EC 30392 Mrs. Barbara Carter Vol #: 0
EC 30393 Mrs. Eleanore Wasson Vol #: 0
EC 30394 Dr. Melissa Tommasino-Storz Vol #: 0
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EC 30403 Ms. Leah Metcalfe Vol #: 0
EC 30404 Mrs. Leslie LaCava Vol #: 0
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EC 30408 Mrs. Ana Tratras Vol #: 0
EC 30409 Mrs. Rose Campbell Vol #: 0
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EC 30459 Mrs. c. Milan McNall Vol #: 0
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EC 30464 Mrs. Judy Schuler Vol #: 0
EC 30465 Regeneris Skin and Body Centre Vol #: 0
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EC 30471 Mrs. Martha James Vol #: 0
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EC 30500 Ms. Diana Mullman Vol #: 0
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EC 30512 tranquility massage Vol #: 0
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EC 30555 Dr. ROBERT FULFORD Vol #: 0
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EC 30573 Ms. Deana Goodman Vol #: 0
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EC 30576 n/a Vol #: 0
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EC 30578 Ms. Delores Troll Vol #: 0
EC 30579 Heal with Energy Vol #: 0
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EC 30584 Mr. Ronald Tubbs Vol #: 0
EC 30585 Mr. Kevin Hogg Vol #: 0
EC 30586 Ms. Jovida Guevara-Ross Vol #: 0
EC 30587 Ms. Sally McCoy Vol #: 0
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EC 30592 Mr. Christopher Mccuiston Vol #: 0
EC 30593 Mr. Paul Ellars Vol #: 0
EC 30594 Ms. bernadette murphy Vol #: 0
EC 30595 Ms. Tina Kline Vol #: 0
EC 30596 Mr. Aidan Bracken Vol #: 0
EC 30597 Ms. Judith Puhalski Vol #: 0
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EC 30600 Global Health Trax Vol #: 0
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EC 30634 Dr. Nancy Sudak Vol #: 0
EC 30635 Ms. Kobina Wright Vol #: 0
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EC 30658 Ms. LB Lacey Vol #: 0
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EC 30660 Ms. Susan Harvest Vol #: 0
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EC 30663 The Human Lactation Center, Ltd. Vol #: 0
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EC 30667 Mr. ROBERT MILLER Vol #: 0
EC 30668 Mrs. Barbara Fowler Vol #: 0
EC 30669 Mr. Robert Jones Vol #: 0
EC 30670 Mrs. Cynthia Morris Vol #: 0
EC 30671 Dr. Melissa McCabe Vol #: 0
EC 30672 Mrs. MARI FAILING Vol #: 0
EC 30673 Mrs. Paulann Dymond Vol #: 0
EC 30674 Mrs. Donna Rastorfer Vol #: 0
EC 30675 Mr. Richard Pecore Vol #: 0
EC 30676 Ms. Susan Smith Sims Vol #: 0
EC 30677 Mrs. Darla Jones Vol #: 0
EC 30678 personal Vol #: 0
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EC 30681 Private Citizen Vol #: 0
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EC 30683 Mrs. Delia Gordon Vol #: 0
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EC 30685 Mrs. Rose Largen Vol #: 0
EC 30686 Mrs. Carol Gibson Vol #: 0
EC 30687 Mr. MICHAEL PARK Vol #: 0
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EC 30689 Mrs. Heather Ryan Vol #: 0
EC 30690 Mr. Dwayne Ortman Vol #: 0
EC 30691 Miss. sherri poe Vol #: 0
EC 30692 Ms. Judy Richardson Vol #: 0
EC 30693 Ms. Diane Tucker Vol #: 0
EC 30694 Mrs. Barbara Ross Vol #: 0
EC 30695 Ms. susan melka Vol #: 0
EC 30696 The H.E.A.L.T.H. Center Vol #: 0
EC 30697 Mrs. Janet Kelley Vol #: 0
EC 30698 Mrs. Vickie Gregory Vol #: 0
EC 30699 Mrs. Karen Ramsland Vol #: 0
EC 30700 Mrs. Carol Wampler Vol #: 0
EC 30701 Private citizen Vol #: 0
EC 30702 Mr. Tony Tirado Vol #: 0
EC 30703 California College of Ayurveda--Student Vol #: 0
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EC 30705 Ms. Isadora Tavens Vol #: 0
EC 30706 Ms. Corinna Schmidt Vol #: 0
EC 30707 Ms. Katherine F. Gibson Vol #: 0
EC 30708 Mrs. Patricia Tilghman Vol #: 0
EC 30709 Ms. B. Bergeron Vol #: 0
EC 30710 Yale University Vol #: 0
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EC 30719 Dr. Fabiola Hamer Vol #: 0
EC 30720 Mrs. Susan Hornbach Vol #: 0
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EC 30722 Nurse Consultant Vol #: 0
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EC 30727 Mrs. Amy Siegel Vol #: 0
EC 30728 Mr. Robert Ross Vol #: 0
EC 30729 Mrs. Shauna Porter Vol #: 0
EC 30730 Mrs. Kathryn Pulaski Vol #: 0
EC 30731 Ms. J Hale Vol #: 0
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EC 30733 Mrs. Vicki Helser Vol #: 0
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EC 30735 Hormone Lady Enterprises, LLC Vol #: 0
EC 30736 Ms. Alice Worth Vol #: 0
EC 30737 Mrs. Sharon Sommers Vol #: 0
EC 30738 Mrs. Shirley Cameron Vol #: 0
EC 30739 Dr. sheldon weiner Vol #: 0
EC 30740 Mrs. Ellen Brucks Vol #: 0
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EC 30742 Ms. Nikki Porter Vol #: 0
EC 30743 Mrs. Susan Miles Vol #: 0
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EC 30745 Mrs. Linda Duncan Vol #: 0
EC 30746 Mrs. Candice Goch Vol #: 0
EC 30747 Ms. Bonnie Purcell Vol #: 0
EC 30748 Ms. Valerie Giardini Vol #: 0
EC 30749 Ms. Karen Cresap Vol #: 0
EC 30750 Mrs. Barbara Geiger Vol #: 0
EC 30751 Mrs. Darci Hartke Vol #: 0
EC 30752 Mrs. Dorothy Green Vol #: 0
EC 30753 Dr. Lance Seberg Vol #: 0
EC 30754 Ms. MARY JOHNSONSON Vol #: 0
EC 30755 Ms. Joni Loubet-LaBonte Vol #: 0
EC 30756 Ms. CL Cole Vol #: 0
EC 30757 Mrs. Virginia Garrett Vol #: 0
EC 30758 Mrs. Charlene Stuart Vol #: 0
EC 30759 Mrs. Charee Vogel Vol #: 0
EC 30760 Ms. Colleen Stevens Vol #: 0
EC 30761 Mrs. J Mee Vol #: 0
EC 30762 Mr. Matt Essex Vol #: 0
EC 30763 Dr. Elizabeth Ferguson Vol #: 0
EC 30764 Ms. Fay Chew Vol #: 0
EC 30765 Ms. Laverne Stevens Vol #: 0
EC 30766 Mrs. Linda Willis Vol #: 0
EC 30767 Ms. Connie Stevens Vol #: 0
EC 30768 Mrs. Linda Carnes-Jenkins Vol #: 0
EC 30769 Ms. Susan Roelofs-Haughn Vol #: 0
EC 30770 Ms. Christine Florio Vol #: 0
EC 30771 Ms. KANDEE KLEVEN Vol #: 0
EC 30772 Ms. Iris E. Roper Vol #: 0
EC 30773 Mrs. Amy Porter Vol #: 0
EC 30774 Mrs. Carrie Kuhn Vol #: 0
EC 30775 Mrs. Marsha Szczerbiak Vol #: 0
EC 30776 Mr. Kenneth Davis Vol #: 0
EC 30777 Mrs. isabel currey Vol #: 0
EC 30778 Mrs. Jenny Donnelly Vol #: 0
EC 30779 Mr. Robert Bice Vol #: 0
EC 30780 Ms. Jill Saldana Vol #: 0
EC 30781 Ms. Kim McLeveighn Vol #: 0
EC 30782 Ms. Doreen McKay Vol #: 0
EC 30783 Naples New Life Counseling Vol #: 0
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EC 30785 Mrs. Suzanne Rebelo Vol #: 0
EC 30786 Ms. Helena Bartosik Vol #: 0
EC 30787 Links To Health Vol #: 0
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EC 30789 Ms. Sylvia Asten Vol #: 0
EC 30790 Mrs. Victoria McKinney Vol #: 0
EC 30791 Ms. Patricia Hallaren Vol #: 0
EC 30792 Mrs. Maryann Snyder Vol #: 0
EC 30793 Mrs. Alice Chisholm Vol #: 0
EC 30794 Ms. Bonnie Carter Vol #: 0
EC 30795 Ms. Karen Olson Vol #: 0
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EC 30797 Ms. William Mancuso Vol #: 0
EC 30798 Ms. Peggy Perrin Vol #: 0
EC 30799 Mrs. Gina Sidhu Vol #: 0
EC 30800 Mrs. Janet Watson-Weideman Vol #: 0
EC 30801 Ms. Carla Mancuso Vol #: 0
EC 30802 Miss. Julia Page Vol #: 0
EC 30803 Ms. Dorothy Wilcox Vol #: 0
EC 30804 Ms. Michele Grajewski Vol #: 0
EC 30805 Miss. Jacqueline McClinton Vol #: 0
EC 30806 Ms. Nicole Mancuso Vol #: 0
EC 30807 Mrs. Roann Stafford Vol #: 0
EC 30808 Mrs. Maryann Citro Vol #: 0
EC 30809 Arbonne Vol #: 0
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EC 30822 Ms. Morgan Rivers Vol #: 0
EC 30823 retired corrections Vol #: 0
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EC 30830 Dr. Anita Mary Pepi,DC Vol #: 0
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EC 30841 Dr. Edie Ward Vol #: 0
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EC 30850 xxx Vol #: 0
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EC 30853 Ms. Elizabeth Lee Vol #: 0
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EC 30857 Mrs. B Dollander Vol #: 0
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EC 30859 Ms. Karen Green Stone Vol #: 0
EC 30860 Ms. Melissa Davila Vol #: 0
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EC 30871 Dr. Joan Priestley Vol #: 0
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EC 30903 Ms. K.S. Webster Vol #: 0
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EC 30906 Ms. Sheila Young Vol #: 0
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EMC 839 J. Miller Vol #: 76
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2005V-0198 Projector for a Laser Light Show
VRA 1 HFZ-200 to Sapphire Night Club Vol #: 1
2006D-0017 Human Subject Protection--Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of FDA Guidance Documents
C 1 Advanced Medical Technology Association (AdvaMed) Vol #: 1
2006D-0044 Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
C 2 Advanced Medical Technology Association (AdvaMed) Vol #: 1
C 3 etrials, Inc. Vol #: 1
C 4 UCB, Inc. Vol #: 1
C 5 Healthcare Technology Systems Vol #: 1
C 6 Genentech Vol #: 1
2006D-0066 Guidance for Industry and FDA Staff: Whole Grains Label Statements
C 4 Sunnyland Mills Vol #: 1
2006E-0003 Patent Extension Application for BiDIL (combination of hydralazine hydrochloride and isosorbide dinitrate), U.S. Patent No. 4,868,179
C 1 D. Lowe Vol #: 1
2006E-0004 Patent Extension Application for CYMBALTA (duloxetine hydrochloride), U.S. Patent No. 5,023,269
C 2 D. Lowe Vol #: 1
2006E-0042 Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243
C 2 D. Lowe Vol #: 1
2006N-0019 Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
C 1 Musculoskeleletal Transplant Foundation (MTF) Vol #: 2
2006P-0070 Misbranding of generic azithromycin products marketed by Teva Pharmaceuticals USA and Sandoz Inc.
C 1 D. Lowe Vol #: 2
2006P-0084 ANDA Suitability for 1.25 mg, 2.50 mg, 5 mg, and 10 mg Ramipril Tablets
C 2 D. Lowe Vol #: 1
2006P-0092 Determine that Astra Zeneca's Diprivan,Teva Sicor's Propofol Injectable Emulsion, and Bedford Laboratories Propofol Injectable Emulsion are misbranded
C 1 D. Lowe Vol #: 1
2006P-0094 To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
C 3 S. Anderson Vol #: 2
2006P-0098 Seeks a determination that Loperamide hydrochloride 2 mg orally dissolving film strip is suitable for an ANDA based on the reference listed drug loperamide hydrochloride 2 mg oral chewable tablet (Imo
C 1 D. Lowe Vol #: 1
2006P-0101 Petition for Review of Codex Standard for Honey Under 21 CFR 130.6
EMC 1 Florida Department of Agriculture and Consumer Services Vol #: 1
2006P-0102 Take appropriate remedial action relating to an apparent safety issue regarding Bellatal ER
C 1 D. Lowe Vol #: 1
2006P-0103 ANDA Suitability for Temazepam Orally Disintegrating Tablets, 7.5 mg, 15 mg, 22.5 mg, and 30 mg
C 1 D. Lowe Vol #: 1
2006P-0125 Determine whether Dexedrine (dextroamphetamine sulfate) Oral Solution 5 mg/ 5 mL has been voluntarily withdrawn from sale for safety or efficacy reasons
C 1 D. Lowe Vol #: 1

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