| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On January 15, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1975N-0183H
|
| Health-Care Antiseptic Drug Products for OTC Human Use
|
|
|
|
|
| 1977N-0094I
|
| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
|
|
|
|
|
| 1978N-0036L
|
| OTC Laxative
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| 1999N-1168
|
| Public Health Impact of Foodborne Listeria Monocytogenes
|
|
|
|
|
| 2000P-0685
|
| Revise of Yogurt Standards
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| 2002N-0209
|
| Governing First Amendment Case Law
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| 2003E-0249
|
| Patent Extension for Elitek (rasburicase) 5,382,518
|
|
|
|
|
| 2003E-0257
|
| Patent Extension for Neotame, 5,480,668
|
|
|
|
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
|
|
|
|
| 2003N-0344
|
| Consumer-Directed Promotion; Public Meeting
|
|
|
|
|
| 2003P-0091
|
| ANDA to declare that drug prod Hydrocodone Polistirex & Chlo
|
|
|
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
|
|
|
|
| 2003P-0291
|
| Enforce the law and prevent unlaw sale of contact lens
|
|
|
|
|
| 2004P-0006
|
| Stay approval of abbbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
|
|
|
|
|
| 1975N-0183H
|
| Health-Care Antiseptic Drug Products for OTC Human Use
|
|
|
|
|
| SUP
12
|
| Lonza, Inc.
|
| Vol #:
|
| 200
|
|
|
|
|
| 1977N-0094I
|
| Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro
|
|
|
|
|
| SUP
1
Literary
References
|
| Wyeth Consumer Healthcare
|
| Vol #:
|
| 9
|
|
|
|
|
| 1978N-0036L
|
| OTC Laxative
|
|
|
|
|
| C
208
|
| InKline Pharmaceutical Company, Inc. (InKline)
|
| Vol #:
|
| 134
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| C 7353
|
| Y. Dutcher
|
| Vol #:
|
| 305
|
|
|
|
|
| C 7354
|
| M. Hands
|
| Vol #:
|
| 305
|
|
|
|
|
| C 7355
|
| M. Haerr
|
| Vol #:
|
| 305
|
|
|
|
|
| C 7356
|
| A. DeFreitas
|
| Vol #:
|
| 305
|
|
|
|
|
| C 7357
|
| L. Martinelli
|
| Vol #:
|
| 305
|
|
|
|
|
| C 7358
|
| N. Schuster
|
| Vol #:
|
| 305
|
|
|
|
|
| 1999N-1168
|
| Public Health Impact of Foodborne Listeria Monocytogenes
|
|
|
|
|
| TR
4
|
| Risk Assessment and Rick Management Meeting held on 12/04/2003
|
| Vol #:
|
| 29
|
|
| | | | | | | | |
|
|
|
|
| 2000P-0685
|
| Revise of Yogurt Standards
|
|
|
|
|
| C 13
|
| Jerome R. Schindler
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| C 336
|
| P.A. Clark
|
| Vol #:
|
| 125
|
|
|
|
|
| C 337
|
| V. F. Kellaher
|
| Vol #:
|
| 125
|
|
|
|
|
| C
338
|
| University of Kentucky
|
| Vol #:
|
| 125
|
|
|
|
|
| C 339
|
| H.S. Doss,MD,FAAP
|
| Vol #:
|
| 125
|
|
|
|
|
| LET
5
|
| HFD-240 to University of Kentucky
|
| Vol #:
|
| 125
|
|
|
|
|
| 2002N-0209
|
| Governing First Amendment Case Law
|
|
|
|
|
| C
113
|
| Florida Citrus Packers
|
| Vol #:
|
| 26
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| C
215
|
| Consumer Products Manufacturers of Canada (FCPMC)
|
| Vol #:
|
| 20
|
|
|
|
|
| C
216
|
| ReUnion Island Coffee, LimitedPeter Pesce
|
| Vol #:
|
| 20
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| C
288
|
| Confectionery Manufacturers Assn of Canada (CMAC)
|
| Vol #:
|
| 22
|
|
|
|
|
| C
289
|
| ReUnion Island Coffee Limited
|
| Vol #:
|
| 22
|
|
|
|
|
| C
290
|
| Consumer Products Manufacturers of Canada (FCPMC)
|
| Vol #:
|
| 22
|
|
|
|
|
| C
291
|
| Western Grain Elevator Assn
|
| Vol #:
|
| 22
|
|
|
|
|
| 2003E-0249
|
| Patent Extension for Elitek (rasburicase) 5,382,518
|
|
|
|
|
| LET
3
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003E-0257
|
| Patent Extension for Neotame, 5,480,668
|
|
|
|
|
| LET
4
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0341
|
| Requirements for Submission of In Vivo Bioequivalence Data
|
|
|
|
|
| C
1
|
| Hyman,Phelps & McNamara, PC
|
| Vol #:
|
| 1
|
|
|
|
|
| C
2
|
| Roxane Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0344
|
| Consumer-Directed Promotion; Public Meeting
|
|
|
|
|
| SUP
3
|
| Pfizer, Inc.
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003P-0091
|
| ANDA to declare that drug prod Hydrocodone Polistirex & Chlo
|
|
|
|
|
| AMD
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
|
|
|
|
| LET
2
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
