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Dockets Management
Dockets Entered On October 29, 2004
Table of Contents
Docket # Title
1978N-0064 OTC Antiperspirant
1998D-0785 Medical imaging drugs and biologics
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
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-0270 Prohibit False and Misleading Labeling
2004N-0181 Critical Path Initiative
2004P-0127 ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161)
2004P-0220 determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
2004P-0429 Revoke 21 C.F.R. Part 11 in its entirety, and purse implementation of electronic record and signature
2004P-0457 Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
2004P-0483 Petition for rulemaking on Nutrition Labeling for food and beverages sold in single-serving containers
1978N-0064 OTC Antiperspirant
EMC 2 B. Sachau Vol #: 53
1998D-0785 Medical imaging drugs and biologics
C 33 General Electric COmpany (GE Healthcare) Vol #: 6
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 661 Bayer Corporation Vol #: 458
EXB 662 Bayer Corporation Vol #: 458
EXB 663 Bayer Corporation Vol #: 458
EXB 664 Bayer Corporation Vol #: 458
EXB 665 Bayer Corporation Vol #: 458
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 2040 Massachusetts Emergency Contraception Network Vol #: 295
EMC 10928 N. Schroeder Vol #: 296
EMC 10929 E. Taylor Vol #: 296
EMC 10930 J. Kilburn Vol #: 296
EMC 10931 G. Longinetti Vol #: 296
EMC 10932 A. Philbin Vol #: 296
EMC 10933 M. Miracle Vol #: 296
EMC 10934 C. Textoris Vol #: 296
EMC 10935 C. Shultz Vol #: 296
EMC 10936 J. Rovendro Vol #: 296
EMC 10937 A. Bratschie Vol #: 296
EMC 10938 H. Eckman Vol #: 296
EMC 10939 L. Frangipane Vol #: 296
EMC 10940 A. Nelson Vol #: 296
EMC 10941 M. Johantgen, MD Vol #: 296
EMC 10942 R. Frank Vol #: 296
EMC 10943 J. Hale Vol #: 296
EMC 10944 C. Norton Vol #: 296
EMC 10945 K. Ingerson Vol #: 296
EMC 10946 A. Gelman Vol #: 296
EMC 10947 A. Larson Vol #: 296
EMC 10948 A. Nau Vol #: 296
EMC 10949 G. Frazzetta, MD Vol #: 296
EMC 10950 A. Lloyd Vol #: 296
EMC 10951 J. Grace Vol #: 296
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1249 Lisa Vol #: 5
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 383 R. Murray Vol #: 6
EMC 384
Attachment
Calorie Control Council Vol #: 6
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 442 P. Newman Vol #: 9
EMC 443 M. Mitford Vol #: 9
EMC 444 W. McMaster Vol #: 9
EMC 445 No signature Vol #: 9
2003P-0270 Prohibit False and Misleading Labeling
C 81 M. Nonnemacher Vol #: 9
2004N-0181 Critical Path Initiative
EMC 17 W. Graenzer Vol #: 3
2004P-0127 ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161)
PDN 2 HFC-001 to Smart Drug Systems Inc. Vol #: 1
2004P-0220 determine that the reference listed drug Zithromax (azithromycin) oral capsules,NDAS 50-670 was not withdrawn from sale for reasons related to safety or effectiveness
LET 1 HFD-005 to Wapner,Newman,Wigrizer,Brecher Vol #: 1
2004P-0429 Revoke 21 C.F.R. Part 11 in its entirety, and purse implementation of electronic record and signature
EMC 1 Society of Quality Assurance Computer Validation Initiative Committee (CVIC) Vol #: 1
2004P-0457 Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
SUP 1 Endotec, Incorporated Vol #: 3
2004P-0483 Petition for rulemaking on Nutrition Labeling for food and beverages sold in single-serving containers
ACK 1 HFA-305 to Center for Science in the Public Interest Vol #: 1
CP 1
Attachment
Center for Science in the Public Interest Vol #: 1

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