| | | | | | | | | | | |
|
| Dockets Management |
|
| Dockets Entered
On August 1, 2003
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1993P-0174
|
| Amend Regs for Liquid Medicated Animal Feed
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
|
|
| 1996N-0417
|
| CGMP in Mfg. Packing or Holding Dietary Supplements
|
|
|
|
|
| 1998N-0337
|
| Over the counter human drugs labeling requirements
|
|
|
|
|
| 1998N-0359
|
| Program priorities/Center for Food Safety & Applied Nutritin
|
|
|
|
|
| 2002N-0275
|
| Bioterrorism Preparedness; Administrative Detention
|
|
|
|
|
| 2002N-0277
|
| Bioterrorism; Establishment & Maintenance of Records
|
|
|
|
|
| 2002P-0321
|
| Grant relief unwarranted testing for chloramphenicol crabmea
|
|
|
|
|
| 2003M-0343
|
| Premarket Approval, P020052 - Response CV Catheter System
|
|
|
|
|
| 2003N-0069
|
| FDA Task Force on Consumer Health Info for Better Nutrition
|
|
|
|
|
| 2003P-0219
|
| ANADA Suitability for Amoxicillin Oral Paste
|
|
|
|
|
| 2003P-0223
|
| ANADA Suitability for Ivermectin
|
|
|
|
|
| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
|
|
| |
|
| 1993P-0174
|
| Amend Regs for Liquid Medicated Animal Feed
|
|
|
|
|
|
|
| M
1
|
| HFC-22
|
| Vol #:
|
| 1
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids: Reports of Adverse Events; Availability
|
|
|
|
|
|
|
| C 4045
|
| 42 signatures
|
| Vol #:
|
| 375
|
|
|
|
|
| 1996N-0417
|
| CGMP in Mfg. Packing or Holding Dietary Supplements
|
|
|
|
|
|
|
| C
133
|
| Cardinal Nutrition
|
| Vol #:
|
| 21
|
|
|
|
|
| C
134
|
| The Heritage Store, Inc.
|
| Vol #:
|
| 21
|
|
|
|
|
| 1998N-0337
|
| Over the counter human drugs labeling requirements
|
|
|
|
|
|
|
| APP
44
|
| DHHS, Supply Service Center
|
| Vol #:
|
| 9
|
|
|
|
|
| 1998N-0359
|
| Program priorities/Center for Food Safety & Applied Nutritin
|
|
|
|
|
|
|
| C
93
Attachment
|
| International Jelly & Preserve Assn (IJPA)
|
| Vol #:
|
| 7
|
|
|
|
|
| C
94
Attachment
|
| Association for Dressings & Sauces (ADS)
|
| Vol #:
|
| 7
|
|
|
|
|
| 2002N-0275
|
| Bioterrorism Preparedness; Administrative Detention
|
|
|
|
|
|
|
| C
49
|
| Gelatin Manufacturers of Europe (GME)
|
| Vol #:
|
| 8
|
|
|
|
|
| 2002N-0277
|
| Bioterrorism; Establishment & Maintenance of Records
|
|
|
|
|
|
|
|
|
| C
104
|
| Gelatin Manufacturers of Europe (GME)
|
| Vol #:
|
| 16
|
|
|
|
|
| 2002P-0321
|
| Grant relief unwarranted testing for chloramphenicol crabmea
|
|
|
|
|
|
| | | | | | | | |
|
| |
|
| PDN
1
|
| HFC-1 to Olsson, Frank and Weeda, PC
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003M-0343
|
| Premarket Approval, P020052 - Response CV Catheter System
|
|
|
|
|
|
|
| AAV 1
|
| St Jude Medical, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0069
|
| FDA Task Force on Consumer Health Info for Better Nutrition
|
|
|
|
|
|
|
| RPT
1
|
| Task Force Final Report July 2003
|
| Vol #:
|
| 4
|
|
|
|
|
| 2003P-0219
|
| ANADA Suitability for Amoxicillin Oral Paste
|
|
|
|
|
|
|
| PAV
1
|
| HFV-100 to Vetoquinol N.-A. Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0223
|
| ANADA Suitability for Ivermectin
|
|
|
|
|
|
|
| PAV
1
|
| HFV-100 to Shotwell & Carr, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
|
|
|
|
|
|
|
| C
3
Tab
1, 2
|
| Geneva Pharmaceuticals, Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
1
|
| Three Rivers Pharmaceuticals, LLC
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 2
|
| Briend D Klein MA
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 3
|
| Grant Gailey
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 4
|
| Gerard J Richey
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 5
|
| Mindy O'Neill
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 6
|
| Edward Livingston
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 7
|
| Laurie Wood
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 8
|
| number not used
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
9
|
| Frontline Hepatitis
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 10
|
| Jamie Antonia Sym
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 11
|
| Number not used
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 12
|
| Number not used
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 13
|
| Number not used
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 14
|
| Number not used
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 15
|
| Edward Schillmaier
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 16
|
| Valerie Young
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 17
|
| Pam Langford
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 18
|
| Pam Langford
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 19
|
| John M. Danneker
|
| Vol #:
|
| 2
|
|
