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Dockets Management
Dockets Entered On April 21, 2004
Table of Contents
Docket # Title
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
1979P-0055 Avi Laserlumia
1992N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992
1995N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
1997N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2000P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
2000P-0685 Revise of Yogurt Standards
2000P-1322 Food Labeling and Allergen Contamination Control
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2003D-0137 Surgical Masks - Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and FDA; Availability
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
2003P-0551 Citalopram Hydrobromide Capsules
2003P-0555 Maintain the Electroconvulsive Therapy Device in Class III for All Indications
2004D-0042 Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
2004P-0004 Correct of FDA's advice for women who are pregnant, or might become pregnant, and nursing mother, about avoiding harm to your baby or young child from mercury in fish and shellfish
2004P-0131 ANDA Suitability for Tofin (tobramycin for Inhalation)
1977N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products
SUP 51
Attachment
Istituto Di Ricerche Farmacologiche (Mario Negri) Vol #: 235
1979P-0055 Avi Laserlumia
EXP 8 Audio Visual Imagineering, Inc. Vol #: 1
1992N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992
C 129 America's Blood Centers (ABC) Vol #: 8
1995N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
SUP 4
References
Nutraceutical Corporation Vol #: 396
1997N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood
SUP 2
Attachment
Foundation for the Accreditation of Cellular Therapy (FACT) Vol #: 6
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 13708 Neway's, Inc. Vol #: 116
LET 13709 Neway's, Inc. Vol #: 116
LET 13710 Neway's, Inc. Vol #: 116
LET 13711 Neway's, Inc. Vol #: 116
LET 13712 Neway's, Inc. Vol #: 116
2000P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
C 73 M. Julian Vol #: 2
2000P-0685 Revise of Yogurt Standards
C 18 M. Julian Vol #: 2
2000P-1322 Food Labeling and Allergen Contamination Control
C 544 Food Allergy & Anaphylaxis Network Vol #: 30
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
C 1341 10 signatures Vol #: 209
EMC 5741 B. Rolfe Vol #: 211
EMC 5742 K. Ingerman Vol #: 211
EMC 5743 A. Willis Vol #: 211
EMC 5744 E. Gomez Vol #: 211
EMC 5745 G. Lynn Vol #: 211
EMC 5746 D. R. Shanklin Vol #: 211
EMC 5747 M. Gossett Vol #: 211
EMC 5748 M. A. Farris Vol #: 211
EMC 5749 B. West Vol #: 211
EMC 5750 P. E. Magrath Vol #: 211
EMC 5751 L. D. Driscoll Vol #: 211
EMC 5752 E. Oberweiser Vol #: 211
EMC 5753 K. Seabrook Vol #: 211
EMC 5754 E. Charkowski Vol #: 211
EMC 5755 M. Sabo Vol #: 211
EMC 5756 M. Gyll Vol #: 211
EMC 5757 C. Davis Vol #: 211
EMC 5758 A. Christensen Vol #: 211
EMC 5759 D. Geer Vol #: 211
EMC 5760 L. Immel Vol #: 211
EMC 5761 L. Akelian Vol #: 211
EMC 5762 A. Jenkins Vol #: 211
EMC 5763 R. Heller Vol #: 210
EMC 5764 C. Manfroy Vol #: 211
EMC 5765 T. McPeak Vol #: 211
EMC 5766 W. M. Newman Vol #: 211
EMC 5767 F. J. Mackley Vol #: 211
EMC 5768 H. Bass Vol #: 211
EMC 5769 E. Duke Vol #: 211
EMC 5770 T. D. Johnson Vol #: 211
EMC 5771 E. Radzavich Vol #: 211
EMC 5772 B. Rude Vol #: 211
EMC 5773 C. Houghton Vol #: 211
EMC 5774 C. Draisner Vol #: 211
EMC 5775 I. C. Nordquist Vol #: 211
EMC 5776 E. S. Freel Vol #: 211
EMC 5777 C. Green Vol #: 211
EMC 5778 C. Green Vol #: 211
EMC 5779 R. C. C. Conway Jr. Vol #: 211
EMC 5780 H. Stuart-Lovell Vol #: 211
EMC 5781 M. Howe Vol #: 211
EMC 5782 R. Baynton Vol #: 211
EMC 5783 C. DeMarco Vol #: 211
EMC 5784 V. Allen Vol #: 211
EMC 5785 C. Barnes Vol #: 211
EMC 5786 E. G. Weinberg Vol #: 211
EMC 5787 G. Wright Vol #: 211
EMC 5788 S.Rossomondo Vol #: 211
EMC 5789 D. Knight Vol #: 211
EMC 5790 N. Mosgofian Vol #: 211
EMC 5791 K. Adler Vol #: 211
EMC 5792 R. E. Clark Vol #: 211
EMC 5793 A. McTeer Davis Vol #: 211
EMC 5794 S.Osterland Vol #: 211
EMC 5795 W. Graue Vol #: 211
EMC 5796 K. Wilson Vol #: 211
EMC 5797 C. Coughlin Vol #: 211
EMC 5798 P. Arsenault Vol #: 211
EMC 5799 J. Buchbinder Vol #: 211
EMC 5800 S. Neal Vol #: 211
EMC 5801 B. Bryant Vol #: 211
EMC 5802 N. Fine Vol #: 211
EMC 5803 J. Cahill Vol #: 211
EMC 5804 L. Rossini Vol #: 211
EMC 5805 T. Dupree Vol #: 211
EMC 5806 V. Stopfel Vol #: 211
EMC 5807 V. P. Thigen Vol #: 211
EMC 5808 L. Tarnowski Vol #: 211
EMC 5809 J. Lopreste Vol #: 211
EMC 5810 D. Gallagher Vol #: 211
EMC 5811 V. Lippert Vol #: 211
EMC 5812 C. M. Flynn Vol #: 211
EMC 5813 R. V. Dawe Vol #: 211
EMC 5814 J. Evans Vol #: 211
EMC 5815 P. Mooney Vol #: 211
EMC 5816 S. Scheib Vol #: 211
EMC 5817 J. Johnson Vol #: 211
EMC 5818 C. Kanitz Vol #: 211
EMC 5819 J. Trychta Vol #: 211
EMC 5820 R. Doe Vol #: 211
EMC 5821 C. Reger Vol #: 211
EMC 5822 J. Levy Vol #: 211
EMC 5823 J. Lane-Perkins Vol #: 211
EMC 5824 M. M. Giese Vol #: 211
EMC 5825 D. Eisenberg Vol #: 211
EMC 5826 L. Lingel Vol #: 211
EMC 5827 N.Cushing-Daniels Vol #: 211
EMC 5828 M.Hochman Vol #: 211
EMC 5829 L. Hamilton-Korey Vol #: 211
EMC 5830 S. Kibel Vol #: 211
2003D-0137 Surgical Masks - Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and FDA; Availability
C 5 Kimberly-Clark Corporation Vol #: 1
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
C 101 J. Korsmo Vol #: 37
C 102 J. Korsmo Vol #: 37
C 103 L. Porter Vol #: 37
C 104 J. Fox Vol #: 37
C 105 C. Smith Vol #: 37
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
C 7 M. Julian Vol #: 1
2003P-0551 Citalopram Hydrobromide Capsules
LET 1 HFD-600 to Frommer Lawrence & Haug, LLP Vol #: 1
2003P-0555 Maintain the Electroconvulsive Therapy Device in Class III for All Indications
C 7 A. Beard Vol #: 1
SUP 1 Depression and Bipolar Support Alliance Vol #: 2
2004D-0042 Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
SUP 1
Attachment
Dana-Farber Cancer Institute Vol #: 1
2004P-0004 Correct of FDA's advice for women who are pregnant, or might become pregnant, and nursing mother, about avoiding harm to your baby or young child from mercury in fish and shellfish
LET 2 HFS-6 to Environmental Working Group Vol #: 1
2004P-0131 ANDA Suitability for Tofin (tobramycin for Inhalation)
C 1 Chiron Corporation (Chiron) Vol #: 1

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