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Dockets Management
Dockets Entered On October 17, 2005
Table of Contents
Docket # Title
1977N-0318 Penicillin & Tetracycline and all Combinations
2001D-0044 Clinical Laboratory Improvement Amendments of 1988
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2004P-0223 Whole Grain Descriptive Claims
2005D-0324 International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
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
2005N-0393 Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
2005P-0037 regarding product of estradiol vaginal cream
2005P-0116 To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
1977N-0318 Penicillin & Tetracycline and all Combinations
ANS 608 HFL-1 to Hon. Joseph D. Early Vol #: 31
2001D-0044 Clinical Laboratory Improvement Amendments of 1988
EC 3 CDPHE Vol #: 3
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 230 R. Quinn Vol #: 4
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
EMC 18 N. Hospodarsky Vol #: 14
EMC 19 D. Wichar Vol #: 14
EMC 20 G. Conrad Vol #: 14
EMC 21 D. Raunio Vol #: 14
EMC 22 L. Raunio Vol #: 14
EMC 23 E. Shellberg Vol #: 14
EMC 24 L. Darrah Vol #: 14
EMC 25 K. Jones Vol #: 14
EMC 26 D. Sagers Vol #: 14
EMC 27 D. Lyon Vol #: 14
EMC 28 M. Donohoe Vol #: 14
EMC 29 G. Rupert Vol #: 14
EMC 30 H. Landa Vol #: 14
EMC 31 L. Pulliam Vol #: 14
EMC 32 D. Davis Vol #: 14
EMC 33 G. Tkalec Vol #: 14
EMC 34 A. Edwardson Vol #: 14
EMC 35 S. Haley Vol #: 14
EMC 36 J. Perlove Vol #: 14
EMC 37 D. Gilliland Vol #: 14
EMC 38 G. Camhi Vol #: 14
EMC 39 S. Stephens Vol #: 14
EMC 40 H. Bradley Vol #: 14
EMC 41 W. Petrilli Vol #: 14
EMC 42 C and D Chamberlain Vol #: 14
EMC 43 D. Cheatham Vol #: 14
EMC 44 K. Zehner Vol #: 14
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 539 Mission Possible International Vol #: 8
EMC 540 Mission Possible International Vol #: 8
EMC 541 Calorie Control Council Vol #: 8
2004P-0223 Whole Grain Descriptive Claims
C 27 Whole Crains Council Vol #: 5
EMC 2 Whole Grains Council Vol #: 5
2005D-0324 International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
EC 1 Abbott 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
EC 859 Ms. Anne Koerber Vol #: 6
EC 860 Ms. Sara Oberst Vol #: 6
EC 861 Internal Medicine and Women's Health Vol #: 6
EC 862 Mrs. Joann Lander Vol #: 6
EC 863 Mrs. Michael Rinasz Vol #: 6
EC 864 Ms. M vanpatten Vol #: 6
EC 865 Mr. Steven Jago Vol #: 6
EC 866 Ms. Marya DeBlasi Vol #: 6
EC 867 Mr. Anton Iberle Vol #: 5
EC 868 Ms. Janet Good Vol #: 6
EC 869 Miss. Jennifer Wilbois Vol #: 6
EC 870 Fitzgerald Pharmacy Vol #: 6
EC 871 Ms. Pat LeMond Vol #: 6
EC 872 Mr. Eric Koretz Vol #: 6
EC 873 Mrs. Mary Barrett Vol #: 6
EC 874 Ms. Mary Hartigan Vol #: 6
EC 875 Women's Care Center Vol #: 6
EC 876 Mr. Steven Armstrong Vol #: 6
EC 877 Ms. Ravenna Oakes Vol #: 6
EC 878 Mrs. Hollie Silberhorn Vol #: 6
EC 879 Mrs. Linda McLaughlin Vol #: 6
EC 880 Ms. Elizabeth Brookbank Vol #: 6
EC 881 Olathe ObGyn Vol #: 6
EC 882 Mr. Peter Vander Bleek Vol #: 6
EC 883 Mrs. Lexie Hallahan, DTR Vol #: 6
EC 884 Dr. C Eric Lindborg Vol #: 6
EC 885 FACOG Vol #: 6
EC 886 Dr. Paul Burstein Vol #: 6
EC 887 Mrs. Kristi Hixson Vol #: 6
EC 888 Mrs. Barbara Rine Vol #: 6
EC 889 ABC Pregnancy Help Center Vol #: 6
EC 890 UCSF MEDICAL SCHOOL Vol #: 6
EC 891 acog Vol #: 6
EC 892 Mr. Patrick Becker Vol #: 6
EC 893 Ms. Amy Bredes Vol #: 6
EC 894 Mr. Raymond Banner Vol #: 6
EC 895 UCSF Vol #: 6
EC 896 Mrs. Katie Guy Vol #: 6
EC 897 Ms. Karla Smith Vol #: 6
EC 898 Ms. margaret bonaparte Vol #: 6
EC 899 Mr. David Paul Xavier Burch Vol #: 6
EC 900 Miss. Susan Liska Vol #: 6
EC 901 Ms. Amy Oggel Vol #: 6
EC 902 Ms. Jennifer Lopez Vol #: 6
2005N-0393 Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational New Drug Regulations
EMC 1 B. Sachau Vol #: 1
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
EAPE 21 Calfee, John Vol #: 1
EAPE 22 Allina, Amy Vol #: 1
EAPE 23 Segale, Pamela Vol #: 1
EAPE 24 Wheeler, Mary Vol #: 1
2005P-0037 regarding product of estradiol vaginal cream
C 1 JRRapoza Assocaites, Inc. Vol #: 1
2005P-0116 To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
EMC 6 J. Sunyecz, M.D., F.A.C.O.G. Vol #: 2
2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
C 32 B. Scheve Vol #: 13

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