| | | | | | | | | | |
|
| |
|
| Dockets Entered
On September 19, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 2004P-0298
|
| Nutrient Content Claims for the Carbohydrate Content of Food
|
|
|
|
|
| 2004P-0557
|
| ANDA for a generic version of Efudex Cream(fluorouracil) cream
|
|
|
|
|
| 2004Q-0083
|
| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
|
|
|
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
|
|
| 2004Q-0098
|
| Qualified Health Claim: Calcium and hypertension
|
|
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
|
|
| 2005D-0223
|
| Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability
|
|
|
|
|
| 2005N-0231
|
| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| 2005P-0048
|
| Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
|
|
|
|
|
|
| 2005P-0107
|
| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
|
|
|
|
|
| 2005P-0116
|
| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
|
|
|
|
|
| 2005P-0127
|
| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
|
|
|
|
|
| 2005P-0267
|
| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
|
|
|
|
|
| 2005P-0360
|
| salmon calcitonin products unless certain conditions are met FDA should not approved
|
|
|
|
|
| 2004P-0298
|
| Nutrient Content Claims for the Carbohydrate Content of Food
|
|
|
|
|
| ANS
1
|
| HFS-1 to Unilever United States Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0557
|
| ANDA for a generic version of Efudex Cream(fluorouracil) cream
|
|
|
|
|
| C
1
|
| Rothwell Figg Ernst & Manbeck PC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004Q-0083
|
| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
|
|
|
|
|
| PRC
1
|
| Fleminger Inc
|
| Vol #:
|
| 8
|
|
|
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
|
|
| LET
10
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 15
|
|
|
|
|
| 2004Q-0098
|
| Qualified Health Claim: Calcium and hypertension
|
|
|
|
|
| LET
12
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 9
|
|
| |
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
|
|
| LET
10
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 6
|
|
|
|
|
| 2005D-0223
|
| Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability
|
|
|
|
|
| C
2
|
| GE Healthcare, General Electric Company
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0231
|
| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
|
|
|
|
|
|
|
|
| | | | | | | | |
|
| |
|
| C
3
|
| Paperboard Packaging Council
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| C 568
|
| L Roberts
|
| Vol #:
|
| 20
|
|
|
|
|
| C 569
|
| C L Hansen
|
| Vol #:
|
| 20
|
|
|
|
|
| C 570
|
| P Petrin
|
| Vol #:
|
| 20
|
|
|
|
|
| C 571
|
| J J Ernst
|
| Vol #:
|
| 20
|
|
|
|
|
| C 572
|
| A Horan
|
| Vol #:
|
| 20
|
|
|
|
|
| C 573
|
| B Brandt
|
| Vol #:
|
| 20
|
|
|
|
|
| C 574
|
| L Stein
|
| Vol #:
|
| 20
|
|
|
|
|
| C 575
|
| N T Melamed
|
| Vol #:
|
| 20
|
|
|
|
|
| C 576
|
| E Ward
|
| Vol #:
|
| 20
|
|
|
|
|
| C 577
|
| C Ingraham
|
| Vol #:
|
| 20
|
|
|
|
|
| C 578
|
| H M Walborn
|
| Vol #:
|
| 20
|
|
|
|
|
| C 579
|
| J Mellan
|
| Vol #:
|
| 20
|
|
|
|
|
| 2005P-0048
|
| Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda
|
|
|
|
|
|
|
|
|
| C
4
|
| Bayer HealthCare, Consumer Care Division
|
| Vol #:
|
| 3
|
|
|
|
|
| 2005P-0107
|
| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
|
|
|
|
|
| LET
1
|
| HFD-5 to UCSF National Center of Excellence in WOmen's Health
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0116
|
| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
|
|
|
|
|
| C 3
|
| S Sellers PharmD MPH
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005P-0127
|
| Abbreviated New Drug Applications(ANDA's) referencing Arava(leflunomide) tablets
|
|
|
|
|
| PDN
1
|
| HFD-1 to Covington & Burling
|
| Vol #:
|
| 2
|
|
|
|
|
| 2005P-0267
|
| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
|
|
|
|
|
| C 21
|
| C G Conrad
|
| Vol #:
|
| 2
|
|
|
|
|
| C 22
|
| K Crawford
|
| Vol #:
|
| 2
|
|
|
|
|
| C 23
|
| R S Middleton
|
| Vol #:
|
| 2
|
|
|
|
|
| C 24
|
| R Nagubadi
|
| Vol #:
|
| 2
|
|
|
|
|
| C 25
|
| T Chau
|
| Vol #:
|
| 2
|
|
|
|
|
| C 26
|
| J Skurhs
|
| Vol #:
|
| 2
|
|
|
|
|
| C 27
|
| Anesthesiologists for the Safe Administration of Propofol
|
| Vol #:
|
| 2
|
|
|
|
|
| C 28
|
| S S Adams
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 49
|
| Dr. Steven Dobryman
|
| Vol #:
|
| 2
|
|
