| | | | | | | | | | |
|
|
| Dockets Entered
On June 15, 2005
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
|
|
| 2003N-0161
|
| Medical Devices;Reprocessed Single-Use Devices;Termination
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
| 2004N-0527
|
| Medical Devices; Medical Device Reporting
|
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
|
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
|
|
| 2005E-0233
|
| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
|
|
|
| 2005E-0234
|
| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
|
|
|
| 2005E-0235
|
| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
|
|
|
| 2005E-0236
|
| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,912,246
|
|
|
| 2005P-0212
|
| ANDA suitability petition for Lamotrigine 50 milligram and 250 milligram oral tablets
|
|
|
| 2005P-0232
|
| Baby Chamonile Juice, 100% natural juice,containing chamomile flowers and filtered baby water
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
| RPT
271
|
| Biocodex, Inc
|
| Vol #:
|
| 203
|
|
|
| RPT
272
|
| Enzymotec Ltd
|
| Vol #:
|
| 204
|
|
|
| RPT 273
|
| Technology Commercializatoin Corp
|
| Vol #:
|
| 209
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET
16195
|
| Enzymatic Therapy
|
| Vol #:
|
| 143
|
|
|
| LET
16196
|
| Natrol, Inc.
|
| Vol #:
|
| 143
|
|
|
| LET
16197
|
| Bayer HealthCare Consumer Care Division
|
| Vol #:
|
| 143
|
|
|
| LET 16198
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 144
|
|
|
| LET 16199
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 144
|
|
|
| LET 16200
|
| Source Naturals
|
| Vol #:
|
| 144
|
|
|
| LET 16201
|
| Dolisos American, Inc.
|
| Vol #:
|
| 144
|
|
|
| LET 16202
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 144
|
|
|
| LET 16203
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 144
|
|
|
| LET 16204
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 144
|
|
|
| LET 16205
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 144
|
|
|
| LET 16206
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 144
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| C 18231
|
| A. B. Bartholmew
|
| Vol #:
|
| 516
|
|
| | | | | | | | |
|
|
| C 18232
|
| S. E. Pedlow
|
| Vol #:
|
| 516
|
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
|
|
| C
40
|
| AdvaMed
|
| Vol #:
|
| 2
|
|
|
| 2003N-0161
|
| Medical Devices;Reprocessed Single-Use Devices;Termination
|
|
|
| C
6
|
| AdvaMed
|
| Vol #:
|
| 1
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
| C
41
|
| The Association for Dressing and Sauces
|
| Vol #:
|
| 4
|
|
|
| C
42
|
| Food Products Association
|
| Vol #:
|
| 4
|
|
|
| 2004N-0527
|
| Medical Devices; Medical Device Reporting
|
|
|
| NCD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
|
|
| C
103
|
| Bariatric Weight Loss Center
|
| Vol #:
|
| 9
|
|
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
|
|
| C
5
|
| AstraZeneca
|
| Vol #:
|
| 2
|
|
|
| 2005E-0233
|
| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
|
|
|
| APP
1
|
| Harald Breivik et al.
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005E-0234
|
| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
|
|
|
| APP
1
|
| Gilead Sciences, Inc.
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005E-0235
|
| Patent Extension Application for VESIcare (solifenacin succinate), U.S. Patent No. 6,017,927
|
|
|
| APP
1
|
| Yamanouchi Pharmaceutical Co., Ltd
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005E-0236
|
| Patent Extension Application for MULTIHANCE (gadobenate dimeglumine), U.S. Patent No. 4,912,246
|
|
|
| APP
1
|
| Bracco International B.V.
|
| Vol #:
|
| 1
|
|
|
| LET
1
|
| U.S. Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2005P-0212
|
| ANDA suitability petition for Lamotrigine 50 milligram and 250 milligram oral tablets
|
|
|
| WDL
1
|
| Pharmaceutical Patent Attorneys
|
| Vol #:
|
| 1
|
|
|
| 2005P-0232
|
| Baby Chamonile Juice, 100% natural juice,containing chamomile flowers and filtered baby water
|
|