| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On July 13, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
|
|
|
|
| 1997N-0484T
|
| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| 2004N-0432
|
| Radioactive Drugs for Certain Research Uses; Public Meeting
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| 2004N-0480
|
| The Minor Use & Minor Species (MUMS) Animal Health Act
|
|
|
|
|
| 2005D-0122
|
| Guidance for Industry on Exploratory IND Studies
|
|
|
|
|
| 2005N-0098
|
| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
|
|
|
|
|
| 2005P-0008
|
| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
|
|
|
|
|
| 2005P-0046
|
| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
|
|
|
|
|
| SUP
56
Attachment
|
| Bayer HealthCare
|
| Vol #:
|
| 257
|
|
|
|
|
| 1997N-0484T
|
| Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
|
|
|
|
|
| EMC 4
|
| S. Levy, RN
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
|
|
|
|
| CS
9
|
| HFA-305
|
| Vol #:
|
| 2
|
|
|
|
|
| SD
1
|
| HF-3 to Ecumed Health Group
|
| Vol #:
|
| 2
|
|
| |
|
| 2004N-0432
|
| Radioactive Drugs for Certain Research Uses; Public Meeting
|
|
|
|
|
| C 11
|
| M. Parisi, MD, MS, Ed
|
| Vol #:
|
| 2
|
|
|
|
|
| C 12
|
| M. Gelfand, MD
|
| Vol #:
|
| 2
|
|
|
|
|
| C 13
|
| E. Effmann, MD
|
| Vol #:
|
| 2
|
|
|
|
|
| C
14
|
| Society of Pediatric Radiology
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| C 48
|
| L. Lambert
|
| Vol #:
|
| 4
|
|
|
|
|
| C 49
|
| M. E. Ward
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004N-0480
|
| The Minor Use & Minor Species (MUMS) Animal Health Act
|
|
|
|
|
| C
4
|
| University of Florida
|
| Vol #:
|
| 1
|
|
| |
|
| 2005D-0122
|
| Guidance for Industry on Exploratory IND Studies
|
|
|
|
|
| C
4
|
| AstraZeneca, LP
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
|
| GE Healthcare
|
| Vol #:
|
| 1
|
|
|
|
|
| C
6
|
| Eli Lilly and Company (Lilly)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
7
|
| GlaxoSmithKline (GSK)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| C
8
|
| J. Coupal, PhD., BCNP
|
| Vol #:
|
| 1
|
|
|
|
|
| C
9
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 1
|
|
| |
|
| 2005N-0098
|
| Food and Drug Administration/Drug Information Association Cross Labeling Workshop: Combination Products and Mutually Conforming Labeling
|
|
|
|
|
| C
2
|
| Advanced Medical Technology Association (AdvaMed)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0008
|
| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
|
|
|
|
|
| RC
3
|
| Ivax Pharmaceuticals, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005P-0046
|
| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
|
|
|
|
|
| RC
2
|
| Ivax Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
