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Dockets Management
Dockets Entered On November 2, 2004
Table of Contents
Docket # Title
1976N-0052N OTC Nasal Decongestants
1999P-1340 Declared Eternity eau de Parfum Misbranded
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002E-0340 Antagon, U.S. Patent No. 4,801,577
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
2004D-0193 Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2004N-0289 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
2004P-0386 Reject New Drug Application 21-695
2004P-0485 require the source of the dietary ingredient lycopene to be identified as from tomato,fungus, or synthetic
1976N-0052N OTC Nasal Decongestants
NPR 3 FDA Vol #: 77
1999P-1340 Declared Eternity eau de Parfum Misbranded
EMC 558 L. Litwin Vol #: 24
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 666 Bayer Corporation Vol #: 459
EXB 667 Bayer Corporation Vol #: 459
EXB 668 Bayer Corporation Vol #: 459
EXB 669 Bayer Corporation Vol #: 459
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 10978 E. Edenfield Vol #: 296
EMC 10979 A. Irick Vol #: 296
EMC 10980 B. Crawford, PhD Vol #: 296
EMC 10981 O. Morderer Vol #: 296
2002E-0340 Antagon, U.S. Patent No. 4,801,577
N 1 FDA Vol #: 1
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
C 27 R. Mullin Vol #: 1
2004D-0193 Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
EMC 291 M. Alper, MD Vol #: 5
2004N-0289 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
C 3 Pfizer, Inc. Vol #: 1
2004P-0386 Reject New Drug Application 21-695
RC 1
List of Exhibits
Exhibits
Arnold and Porter, LLP Vol #: 1
2004P-0485 require the source of the dietary ingredient lycopene to be identified as from tomato,fungus, or synthetic
ACK 1 HFA-305 to Kirkpatrick and Lockhart LLP Vol #: 1
CP 1 Kirkpatrick and Lockhart LLP Vol #: 1

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