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Dockets Management
Dockets Entered On September 1, 2005
Table of Contents
Docket # Title
1976N-0052G OTC general comments & combinations
2005D-0174 Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
2005D-0312 Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
2005N-0343 Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
2005P-0282 Require Health Messages on Soft Drinks
1976N-0052G OTC general comments & combinations
EREG 1 FDA Vol #: 35
2005D-0174 Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
EC 9 Healthcare Distribution Management Association Vol #: 1
EC 10 McGrath & Breitfeller Vol #: 1
EC 11 McGrath & Breitfeller Vol #: 1
EC 12
Attachment
MTS-Medication Technologies,Inc. Vol #: 1
EC 13 American Society of Consultant Pharmacists Vol #: 1
EC 14 Mr. Steven Zahn Vol #: 1
2005D-0312 Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
C 1 KV Pharmaceutical Company Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
C 259 M. Robinson Vol #: 10
C 260 J. Ferree Vol #: 10
C 261 M. Ferry Vol #: 10
C 262 S. Settlemoire, III Vol #: 10
C 263 B. Griffiths Vol #: 10
C 264 L. Madsen Vol #: 10
C 265 E. Fisher Vol #: 10
C 266 W. Johann Vol #: 10
C 267 M. Gabriel Vol #: 10
C 268 R. Hart Vol #: 10
C 269 No signature Vol #: 10
C 270 R. Kistler Vol #: 10
C 271 N. Lewis Vol #: 11
C 272 B and N Huggenvik Vol #: 11
C 273 F. Alley Vol #: 11
C 274 E. Wyant Vol #: 11
C 275 T. Wille Vol #: 11
C 276 N. Carlson Vol #: 11
C 277 V. Rickis Vol #: 11
C 278 J. Matthew Vol #: 11
C 279 R. Gordon Vol #: 11
C 280 L. Will Vol #: 11
C 281 I. Paul Vol #: 11
C 282 D. Perez Vol #: 11
C 283 A. Barry Vol #: 11
C 284 N. Fritsch Vol #: 11
C 285 No signature Vol #: 11
C 286 M. Rutledge Vol #: 11
C 287 J. Fagyal Vol #: 11
C 288 Ilegible Vol #: 11
C 289 S. Dankert Vol #: 11
C 290 E. McMullen Vol #: 11
C 291 M. DeGaetano, RN Vol #: 11
C 292 H. Steen Vol #: 11
C 293 W. Leeds Vol #: 11
C 294 E. Jensen Vol #: 11
C 295 T. Hall, D.O. Vol #: 11
C 296 I. Janzen Vol #: 11
C 297 T. Noonan Vol #: 11
C 298 E. Zeis Vol #: 11
C 299 T. McCarthy Vol #: 11
C 300 L. Shinolt, RN Vol #: 11
C 301 H. Burdette Vol #: 11
C 302 W. Markman Vol #: 11
C 303 M. Stawasz Vol #: 11
C 304 F. Conklin Vol #: 11
C 305 A. Flesche Vol #: 11
EC 274 North Raleigh Celiac Support Group Vol #: 4
EC 275 Mr. Allen Kaszubski Vol #: 4
EC 276 Near West Suburban Celiac Group Vol #: 4
EC 277 Ms. barbara mclaughlin Vol #: 4
EC 278 Mrs. Naomi Rymer Vol #: 4
EC 279 Mrs. Tracy Boyles Vol #: 4
EC 280 Mr. Jeffrey Natterman Vol #: 4
EC 281 Mrs. Marie Yearwood Vol #: 4
EC 282 Mrs. Jean Marston Vol #: 4
EC 283 Mr. Gerard Ayotte Vol #: 4
EC 284 Mr. Douglas Fischer Vol #: 4
EC 285 GEHA-GOVERMENT EMPLOYEE HOSPITAL ASSOCIATION Vol #: 4
EC 286 Mrs. Susan Zelisko Vol #: 4
EC 287 Mrs. Kathy Fiala Vol #: 4
EC 288 Mrs. Debbie Kullberg Vol #: 4
EC 289 CSAceliacs Vol #: 4
EC 290 Mrs. Nancy Zimmer Vol #: 4
EC 291 Mrs. Donna Koehler Vol #: 4
EC 292 Mrs. Debra Coe Vol #: 4
EC 293 Mrs. Debra Coe Vol #: 4
EC 294 Ms. Myra Fribourg Vol #: 4
EC 295 Mrs. Mary Emory Vol #: 4
EC 296 Mrs. sharon valdez Vol #: 4
EC 297 Mr. Steve Veach Vol #: 4
EC 298 Mr. Kenneth Downey Vol #: 4
EC 299 Mrs. Jennifer Walter Vol #: 4
EC 300 Seager Enterprises Corporation Vol #: 4
EC 301 Mr. Jay G. Lamb Vol #: 4
EC 302 Mrs. Amanda Hutchison Vol #: 4
EC 303 Mrs. Kelly Burr Vol #: 4
EC 304 Mr. Thomas Burr Vol #: 4
2005N-0343 Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
N 1 FDA Vol #: 1
2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
C 1 P. Aiello, MD Vol #: 1
EC 10 Mrs. Marion Blumenstock Vol #: 2
EC 11 Mr. William Rivkin Vol #: 2
EC 12 UCLA Medical Center, Dept of Pharm Serv Vol #: 2
EC 13 Mr. Alexander Clague Vol #: 2
EC 14 Mr. irwin seltzer Vol #: 2
EC 15 Ms. Laura Marshall Vol #: 2
EC 16 Ms. Stephanie Smart Vol #: 2
EC 17 Mr. Rick LaChance Vol #: 2
EC 18 Ms. Susan Nowak Vol #: 2
EC 19 Mrs. Wanda Stapleton Vol #: 2
EC 20 Mrs. Wanda Stapleton Vol #: 2
EC 21 NYC DOE Vol #: 2
EC 22 Mr. A. A. Rankis Vol #: 2
EC 23 Ms. C. Parks Vol #: 2
EC 24 Mr. Aaron Salvo Vol #: 2
EC 25 Ms. Colleen Meegan Vol #: 2
EC 26 Ms. SAMANTHA MAUERMEYER Vol #: 2
EC 27 Priority Healthcare Vol #: 2
EC 28 Ms. Candace Churchill Vol #: 2
EC 29 Mrs. melissa sansing Vol #: 2
EC 30 Retired Vol #: 2
EC 31 Mrs. Karen Zeiger Vol #: 2
EC 32 Ms. Jane Hagan Vol #: 2
EC 33 Dr. Mark Collum Vol #: 2
EC 34 Mr. Ralph Hudson Vol #: 2
EC 35 Mrs. Michelle Thornton-Taylor Vol #: 2
EC 36 Mrs. Anita vanHeeswyk Vol #: 2
EC 37 Dr. Martha Hayes Vol #: 2
EC 38 Dr. Sarah Scarpace Vol #: 2
EC 39 Mrs. Diane Green Vol #: 2
EC 40 Mr. robert falcone Vol #: 2
EC 41 Ms. Shirley Crider Vol #: 2
EC 42 Ms. Heather Johnson Vol #: 2
EC 43 Mr. Richard J. Lamermayer Vol #: 2
EC 44 Ms. Edmund Brophy Vol #: 2
EC 45 Planned Parenthood Vol #: 2
EC 46 Mrs. Clara Gondreau Vol #: 2
EC 47 New Mexico State University Vol #: 2
EC 48 Mrs. Leta Sinnen Vol #: 2
EC 49 Mr. Christopher Landauer Vol #: 2
EC 50 Mrs. Christine Valli Vol #: 2
EC 51 Dr. Stephine Heitkemper Vol #: 2
EC 52 Mr. Steven Zahn Vol #: 2
EC 53 Mr. Tim McGhee Vol #: 2
EC 54 Mr. Scott Rommel Vol #: 2
EC 55 Mrs. ELIZABETH ANN HYLAND Vol #: 2
EC 56 Mrs. Rebecca Porter Vol #: 2
EC 57 United States of Ameica Citizen Vol #: 2
EC 58 Ventura Associates Vol #: 2
EC 59 Ms. Ruth Tehila Leonard Vol #: 2
EC 60 Ms. Donna Hoaglin Vol #: 2
EC 61 U. of South FL Public Health Student Association Vol #: 1
EC 62 Ms. Trudie Gardner Vol #: 2
EC 63 Ms. Karen Andreas Vol #: 2
EC 64 Mrs. Alice Cox Vol #: 2
EC 65 Ms. Amy Ray Vol #: 2
EC 66 Ms. Debora Baird Vol #: 2
EC 67 Mr. Douglas Lucas Vol #: 2
EC 68 Ms. Lynn Max Vol #: 2
EC 69 Ms. Elizabeth Rahn Vol #: 2
EC 70 Ms. helena champion Vol #: 2
EC 71 Dr. Carol Van Hulle Vol #: 2
EC 72 Ms. Cathy Bettoney Vol #: 2
EC 73 Mr. Stephen Ricci Vol #: 2
EC 74 n/a Vol #: 2
EC 75 Ms. Peggy Andreas Vol #: 2
EC 76 Mrs. Lucia Rosati Vol #: 2
EC 77 Mr. Brent Carlson Vol #: 2
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
EC 44 Dr. Mary Tuman Vol #: 2
EC 45 Bellingham Anesthesia Associates, P.S. Vol #: 2
EC 46 Dr. Steven Roth Vol #: 2
EC 47 Dr. Marc Koch Vol #: 2
EC 48 Dr. Jeffrey Rubin Vol #: 2
2005P-0282 Require Health Messages on Soft Drinks
C 11 R. Senn Vol #: 1
C 12 E. Boyce Vol #: 1
C 13 Eligible Vol #: 1
C 14 Form Letters Vol #: 2

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