| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On September 22, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
|
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
|
|
| 2005D-0288
|
| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
|
|
|
|
|
| 2005D-0334
|
| Guidance for Industry on the Pediatric Research Equity Act
|
|
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| 2005P-0107
|
| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
|
|
|
|
|
| 2005P-0204
|
| deny the pre-market approval applications of Mentor Corporation and Inamed Corporation for approval of silicone-gel filled breast implant products
|
|
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
|
|
| HER
2
|
| University of Illinois School of Public Health
|
| Vol #:
|
| 8
|
|
|
|
|
| 2003P-0126
|
| Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
|
|
|
|
|
| C
5
|
| Abbott
|
| Vol #:
|
| 4
|
|
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
|
|
| C
5
|
| Abbott Laboratories
|
| Vol #:
|
| 5
|
|
|
|
|
| 2005D-0288
|
| International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management
|
|
|
|
|
| C
1
|
| Johnson & Johnson
|
| Vol #:
|
| 1
|
|
|
|
|
| C
2
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
| |
|
| 2005D-0334
|
| Guidance for Industry on the Pediatric Research Equity Act
|
|
|
|
|
| C
1
|
| The Children's Hospital
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
|
|
|
|
| CS 2
|
| HFA-305
|
| Vol #:
|
| 1
|
|
|
|
|
| OR 2
|
| HF-3 to TMJ Implants Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| C 620
|
| Gluten-Free Living
|
| Vol #:
|
| 22
|
|
|
|
|
| C 621
|
| M Sivak
|
| Vol #:
|
| 22
|
|
|
|
|
| C 622
|
| G A Bell
|
| Vol #:
|
| 22
|
|
|
|
|
| C 623
|
| P McGinley
|
| Vol #:
|
| 22
|
|
|
|
|
| C 624
|
| J Lugg
|
| Vol #:
|
| 22
|
|
|
|
|
| 2005P-0107
|
| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
|
|
|
|
|
| LET
2
|
| UCSF Division of Cardiology
|
| Vol #:
|
| 1
|
|
