|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dockets Management
|
|
| Dockets
Entered On July 28, 2003
|
|
|
|
|
|
|
|
|
|
|
| Docket
#
|
| Title
|
|
|
|
|
|
|
| 1982N-0166
|
| OTC Drug Products for Overindulgence
of Alcohol
|
|
|
|
|
| 1993N-0182
|
| Oral & Rectal OTC DP
w/Aspirin & Nonaspirin Salicylates
|
|
|
|
|
| 1993P-0396
|
| Require NADA for Prod used
in Freshwater/Marine Aquariums
|
|
|
|
|
| 1999P-4618
|
| Review and Approve ANDA
Suitability Petitions
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry:
Opportunity for Hearing
|
|
|
|
|
| 2001E-0091
|
| Argatroban, Patent Extension
Application No.5,214,052
|
|
|
|
|
| 2001E-0094
|
| Calozal, Patent Extension
Application No. 4,412,992
|
|
|
|
|
| 2001E-0405
|
| Patent Term Extension Application,
Evoxac No. 4,855,290
|
|
|
|
|
| 2001E-0420
|
| Patent Term Extension Application
for Lotronex No. 5,360,800
|
|
|
|
|
|
|
| 2001P-0290
|
| Definition for the term
"stone ground" for wheat flour
|
|
|
|
|
| 2002D-0526
|
| Guidance for drug Chemistry,
Manufacturing, Control Info.
|
|
|
|
|
| 2002E-0022
|
| Patent Term Application
for Solage No. 5,194,247
|
|
|
|
|
| 2002E-0024
|
| Patent Term Application
for Gleevac No. 5,521,184
|
|
|
|
|
| 2002E-0339
|
| Benicar, U.S. Patent No.
5,616,599
|
|
|
|
|
| 2002N-0434
|
| Withdrawal of Certain Proposed
rules & other propose action
|
|
|
|
|
| 2002N-0445
|
| FDA Regulation of Combination
Products; Public Hearing
|
|
|
|
|
| 2003E-0036
|
| Patent Extension Application
for SPECTRACEF No. 4,839,350
|
|
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request
for Information
|
|
|
|
|
| 2003N-0312
|
| Discussion of
Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety
Program for the Manufacture and Distribution of Animal Feeds
Determine if Levorphanol Tartrate withdrawn for safety reason
|
|
|
|
|
|
| 2003P-0006
|
|
|
|
|
|
|
| 2003P-0027
|
| Amend labeling for skelaxin
(metaxalone) tablets to restore
|
|
|
|
|
| 2003P-0029
|
| Remove metered-dose inhalers
(MDI) containing moiety albuter
|
|
|
|
|
| 2003P-0340
|
| Request for Evaluation
of Automatic Class III Designation (De Novo) for Endotoxin Activity
Assay (EAA) (K021885)
|
|
|
|
|
|
|
|
|
|
|
|
|
| 1982N-0166
|
| OTC Drug Products
for Overindulgence of Alcohol
|
|
|
|
|
|
|
| C
17
|
| Procter & Gamble Company
|
| Vol #:
|
| 1
|
|
|
|
|
| 1987F-0179
|
| Sucrose polyester
as replacement for fats & oil in food
|
|
|
|
|
|
| | | | | | | | |
| |
|
|
| SUP 8
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 41
|
| |
|
|
| 1993N-0182
|
| Oral & Rectal OTC DP w/Aspirin & Nonaspirin Salicylates
|
|
|
|
|
|
|
| C
8
|
| Procter & Gamble Company
|
| Vol #:
|
| 1
|
| |
|
|
| 1993P-0396
|
| Require NADA for Prod used in Freshwater/Marine Aquariums
|
|
|
|
|
|
|
| LET
3
|
| HFC-1 to Committee on Safe & Effective Aquarium Drugs
|
| Vol #:
|
| 1
|
| |
|
|
| 1997D-0302
|
| Consumer-Directed Broadcast Advertisements
|
|
|
|
|
|
|
| C 34
|
| Mary Anne Whelan PhD, MD
|
| Vol #:
|
| 1
|
| |
|
|
| 1997P-0329
|
| Require Quantitative Labeling of Caffeine Content
|
|
|
|
|
|
|
| C 244
|
| Ruth Whalen Mlt (ASP)
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 67
|
| Bob Goldbaum
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 68
|
| M Petti
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 69
|
| Brad Ward
|
| Vol #:
|
| 7
|
| |
|
|
| 1998D-1146
|
| Microbial effects of antimicrobial new animal drugs/human sa
|
|
|
|
|
|
|
| C 102
|
| Animal Health Institute
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 687
|
| Jeremiah Eldred
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 688
|
| Nancy Thompson-Handler
|
| Vol #:
|
| 19
|
| |
|
|
| EMC 689
|
| Ira Nirenberg
|
| Vol #:
|
| 19
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
|
|
| C 755
|
| Eunice L. Woo
|
| Vol #:
|
| 21
|
| |
|
|
| 1999P-4618
|
| Review and Approve ANDA Suitability Petitions
|
|
|
|
|
|
|
| WDL
1
|
| HFD-7 to Generic Pharmaceutical Association
|
| Vol #:
|
| 1
|
| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
|
|
| TR
11
|
| Corrected April 30, 2003 Transcript
|
| Vol #:
|
| 383
| Part 2 of transcript | |
|
|
| TR
12
|
| Corrected May 1, 2003 Transcript
|
| Vol #:
|
| 384
|
| |
|
|
| TR
13
|
| Corrected May 2, 2003 Transcript
|
| Vol #:
|
| 385
|
| |
|
|
| 2001E-0091
|
| Argatroban, Patent Extension Application No.5,214,052
|
|
|
|
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2001E-0094
|
| Calozal, Patent Extension Application No. 4,412,992
|
|
|
|
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| 2001E-0405
|
| Patent Term Extension Application, Evoxac No. 4,855,290
|
|
|
|
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2001E-0420
|
| Patent Term Extension Application for Lotronex No. 5,360,800
|
|
|
|
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
|
|
| C 290
|
| Gloria Halbach
|
| Vol #:
|
| 38
|
| |
|
|
| 2001P-0290
|
| Definition for the term "stone ground" for wheat flour
|
|
|
|
|
|
|
| LET
1
|
| HFS-800 to Hodgson Mill
|
| Vol #:
|
| 1
|
| |
|
|
| 2001V-0216
|
| Projector for a laser light show
|
|
|
|
|
| |
|
|
| VRA 2
|
| HFZ-300 to Foxwoods Resort and Casino
|
| Vol #:
|
| 1
|
| |
|
|
| 2002D-0526
|
| Guidance for drug Chemistry, Manufacturing, Control Info.
|
|
|
|
|
| |
|
|
| EMC
8
|
| Apotex Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2002E-0022
|
| Patent Term Application for Solage No. 5,194,247
|
|
|
|
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2002E-0024
|
| Patent Term Application for Gleevac No. 5,521,184
|
|
|
|
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2002E-0339
|
| Benicar, U.S. Patent No. 5,616,599
|
|
|
|
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2002N-0434
|
| Withdrawal of Certain Proposed rules & other propose action
|
|
|
|
|
|
|
| C
11
|
| National Yogurt Association
|
| Vol #:
|
| 1
|
| |
|
|
| C
12
|
| Domino Foods, Inc
|
| Vol #:
|
| 3
|
| |
|
|
| C
13
|
| National Soft Drink Association
|
| Vol #:
|
| 3
|
| |
|
|
| C
14
|
| United States Sugar Corporation
|
| Vol #:
|
| 3
|
| |
|
|
| C
15
|
| Dole Food Company, Inc
|
| Vol #:
|
| 3
|
| |
|
|
| C
16
|
| Minn-Dak Farmers Cooperative
|
| Vol #:
|
| 3
|
| |
|
|
| C
17
|
| McKenna Long & Aldridge
|
| Vol #:
|
| 3
|
| |
|
|
| C
18
|
| Monitor Sugar Company
|
| Vol #:
|
| 3
|
| |
|
|
| C
19
|
| National Food Processors Association (NFPA)
|
| Vol #:
|
| 3
|
| |
|
|
| C
20
|
| American Association of Homeopathic Pharmacists (AAHP)
|
| Vol #:
|
| 3
|
| |
|
|
| C 21
|
| Michael W Robichaux
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
| |
|
|
| C
22
|
| Cora Texas Manufacturing Company LLC
|
| Vol #:
|
| 3
|
| |
|
|
| C
23
|
| Corn Refiners Association
|
| Vol #:
|
| 3
|
| |
|
|
| C
24
|
| St Mary Sugar Co-Operative, Inc
|
| Vol #:
|
| 3
|
| |
|
|
| C
25
|
| Iberia Sugar Cooperative Inc
|
| Vol #:
|
| 3
|
| |
|
|
| C
26
|
| Committee for Truth in Psychiatry
|
| Vol #:
|
| 3
|
| |
|
|
| C 27
|
| Florida Crystals dba Okeelanta Corporation
|
| Vol #:
|
| 3
|
| |
|
|
| C
28
|
| Western Sugar Cooperative
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
2
|
| International Hearing Society
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
3
|
| Americ'a Hearing Healthcare Team (AHHT)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
4
|
| International Hydrolyzed Protein Council
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
5
|
| The Glutamate Association (TGA)
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
6
|
| American Academy of Otolaryngology-Head and Neck Surgery, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
7
|
| Institute for Graceful Aging
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
8
|
| women Supporting Choice
|
| Vol #:
|
| 1
|
| |
|
|
| 2002N-0445
|
| FDA Regulation of Combination Products; Public Hearing
|
|
|
|
|
|
|
| LET
2
|
| R. Sheridan Consulting, LLC
|
| Vol #:
|
| 6
| Attachment | |
|
|
| 2003E-0036
|
| Patent Extension Application for SPECTRACEF No. 4,839,350
|
|
|
|
|
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
|
|
|
|
| |
|
|
| EMC 217
|
| Bernard WIndham
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 218
|
| Carl W Tuttle
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 219
|
| Birgit Calhoun
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 220
|
| Guy M and Doreen C Randal
|
| Vol #:
|
| 6
|
| |
|
|
| LET
1
|
| HFW-1 to Hon. Fred Upton
|
| Vol #:
|
| 4
|
| |
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
|
|
|
|
| |
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0006
|
| Determine if Levorphanol Tartrate withdrawn for safety reaso
|
|
|
|
|
|
|
| LET
1
|
| HFD-6 to Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0027
|
| Amend labeling for skelaxin (metaxalone) tablets to restore
|
|
|
|
|
|
|
| LET
1
|
| HFD-005 to Olsson, Frank & Weeda, P.C.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
|
|
|
|
|
| | | | | | | | |
| |
|
|
| RC
1
|
| American Lung Association
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0340
|
| Request for Evaluation of Automatic Class III Designation (De Novo) for Endotoxin Activity Assay (EAA) (K021885)
|
|
|
|
|
|
|
| CP
1
|
| Spectral Diagnostics, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| PAV
1
|
| HFZ-440
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0265
|
| South Beach Laser Light Show and Projector Laser Spectacles Luxme 3003
|
|
|
|
|
|
|
| VRA 1
|
| HFZ-300 to Nier of Texas, Inc. dba South Beach
|
| Vol #:
|
| 1
|
|
|
