| | | | | | | | | | |
| |
|
|
| Dockets Entered
On October 22, 2004
Table of Contents
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
| |
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
| |
|
|
| 2003N-0161
|
| Medical Devices;Reprocessed Single-Use Devices;Termination
|
| |
|
|
| 2003P-0176
|
| Follow-Up Approval of Therapeutic Protein Products
|
| |
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
| |
|
|
| 2004E-0391
|
| Patent Extension for Sensipar (cinacalcet hydrochloride), U.S. Patent No. 6,211,244
|
| |
|
|
| 2004E-0393
|
| Patent Extension for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491
|
| |
|
|
| 2004E-0394
|
| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
|
| |
|
|
| 2004E-0397
|
| Patent Extension for Prilosec OTC (omeprazole magnesium), U.S. Patent No. 5,817,338
|
| |
|
|
| 2004E-0398
|
| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
|
| |
|
|
| 2004E-0399
|
| Patent Extension for Sensipar (cinacelet hydrochloride), U.S. Patent No. 6,313,146
|
| |
|
|
| 2004E-0413
|
| Patent Term Extension for CIALIS (tadalafil), U.S. Patent No. 5,859, 006
|
| |
|
|
| 2004E-0425
|
| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
|
| |
|
|
| 2004E-0444
|
| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
|
| |
|
|
| 2004E-0446
|
| Patent Extension Application for Sensipar (cinacalcet hydrochloride), U.S. Patent No. 6,011,068
|
| |
|
|
| 2004N-0408
|
| Regulatory Site Visit Training Program
|
| |
|
|
| 2004N-0423
|
| Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting
|
| |
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
| |
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
| |
|
|
| 2004P-0225
|
| NDA 21-259 Metadate CD Extended-Release Capsules
|
| |
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
| |
|
|
| RPT
238
|
| Awareness Corporation
|
| Vol #:
|
| 173
|
| |
|
|
| RPT
239
|
| Quinta Naturaceuticals, Inc
|
| Vol #:
|
| 174
|
| |
|
|
| RPT
240
|
| Soft Gel Technologies Incorporated
|
| Vol #:
|
| 175
|
| |
|
|
| RPT
241
References
|
| BTR Group Incorporated
|
| Vol #:
|
| 174
|
| |
|
|
| RPT
242
|
| Ingredia
|
| Vol #:
|
| 176
|
| |
|
|
| RPT 243
|
| Outsource Products Manufacture LLC
|
| Vol #:
|
| 178
|
| |
|
|
| RPT 244
|
| Conseco Sea Buckthorn Co., Ltd
|
| Vol #:
|
| 174
|
| |
|
|
| RPT 245
|
| Conseco Sea Buckthorn Co., Ltd
|
| Vol #:
|
| 174
|
| |
|
|
| RPT 246
|
| AMT Labs, Inc.
|
| Vol #:
|
| 179
|
| |
|
|
| RPT 247
|
| Herbal Cure USA LLC
|
| Vol #:
|
| 174
|
| |
|
|
| RPT 248
|
| Access Business Group LLC
|
| Vol #:
|
| 180
|
| |
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
| |
|
|
| SUP
1
|
| Medtronic Cardiac Surgery Technologies (Medtronic)
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
| |
|
|
| 2003N-0161
|
| Medical Devices;Reprocessed Single-Use Devices;Termination
|
| |
|
|
| SUP
1
|
| Medtronic Cardiac Surgery Technologies (Medtronic)
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0176
|
| Follow-Up Approval of Therapeutic Protein Products
|
| |
|
|
| C
1
|
| University of California
|
| Vol #:
|
| 2
|
| |
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
| |
|
|
| C
35
|
| Sanofi-Synthelabo
|
| Vol #:
|
| 3
|
| |
|
|
| 2004E-0391
|
| Patent Extension for Sensipar (cinacalcet hydrochloride), U.S. Patent No. 6,211,244
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0393
|
| Patent Extension for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0394
|
| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0397
|
| Patent Extension for Prilosec OTC (omeprazole magnesium), U.S. Patent No. 5,817,338
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0398
|
| Patent Extension for IRESSA (gefitinib), U.S. Patent No. 5,770,599
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0399
|
| Patent Extension for Sensipar (cinacelet hydrochloride), U.S. Patent No. 6,313,146
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0413
|
| Patent Term Extension for CIALIS (tadalafil), U.S. Patent No. 5,859, 006
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0425
|
| Patent Extension for Plenaxis (abarelix), U.S. Patent No. 5,843,901
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0444
|
| Patent Extension for BONIVA (ibandronate), U.S. Patent No. 4,927,814
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004E-0446
|
| Patent Extension Application for Sensipar (cinacalcet hydrochloride), U.S. Patent No. 6,011,068
|
| |
|
|
| LET
2
|
| HFD-005 to US Patent and Trademark Office
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0408
|
| Regulatory Site Visit Training Program
|
| |
|
|
| C
2
|
| SICOR Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0423
|
| Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting
|
|
| | | | | | | | |
| |
|
|
| C
1
|
| Command Trust Network, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0454
|
| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
|
| |
|
|
| BKG
1
|
| Background Material Reference #1
|
| Vol #:
|
| 1
|
| |
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
| |
|
|
| C
4
|
| University of California
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0225
|
| NDA 21-259 Metadate CD Extended-Release Capsules
|
| |
|
|
| LET
1
|
| HFD-005 to Celltech Americas, Inc.
|
| Vol #:
|
| 1
|
|
|
