| | | | | | | | | | |
|
| |
|
| Dockets Entered
On September 6, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
|
|
|
|
| 1995N-0294
|
| Quality/fill container; common or unusual name regulations
|
|
|
|
|
| 1998P-0221
|
| DIPRIVAN (propofol) Injectable Emulsion
|
|
|
|
|
| 1999P-0796
|
| Stay the effective date of approval of ANDAs for Diprivan
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| 2004P-0379
|
| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
|
|
|
|
|
| 2005D-0174
|
| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
|
|
|
|
|
| 2005D-0324
|
| International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
|
|
|
|
|
| 2005M-0117
|
| P040020 - Acrysof ReSTOR Apodized Diffractive Optic Posterior Chamber Intraocular Lenses, Models MA60D3 and SA60D3, Approved 3/21/05
|
|
|
|
|
| 2005M-0118
|
| P040024 - Restylane Injectable Gel, Approved 3/25/05
|
|
|
|
|
| 2005M-0129
|
| P040018 - ADVIA Centaur HAV IgM ReadyPack Reagents; ADVIA Centaur HAV IgM Quality Control Materials
|
|
|
|
|
| 2005M-0130
|
| P030052 - UroVysion Bladder Cancer Kit
|
|
|
|
|
| 2005M-0151
|
| P930016/S020 - STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS), Approved 3/17/05
|
|
|
|
|
| 2005M-0158
|
| Bayer Healthcare, LLC; Premarket approval for ADVIA Centaur HBc IgM ReadyPack Reagents and ADVIA Centaur HBc IgM Quality Control Materials, P030040
|
|
|
|
|
| 2005M-0159
|
| Ventana Medical Systems, Inc.; Premarket Approval of Ventana Medical Systems' Pathway Anti-c-KIT (9.7) Primary Antibody, P020055
|
|
|
|
|
| 2005M-0160
|
| BioGenex Laboratories, Inc., Premarket Approval of InSite Her-2/neu kit, P040030
|
|
|
|
|
| 2005M-0191
|
| P040034 - DuraSeal Sealant System
|
|
|
|
|
| 2005M-0192
|
| P040016 - Boston Scientific Corporation Liberte Monorail and Over-the-Wire Coronary Stent Systems
|
|
|
|
|
| 2005M-0193
|
| P030037 - Rithron-XR Coronary Stent System
|
|
|
|
|
| 2005M-0241
|
| P040026 - Orthospec Extracorporeal Shock Wave Therapy Device, Approved 4/1/05
|
|
|
|
|
| 2005M-0270
|
| P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| 2005N-0345
|
| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
|
|
|
|
|
| 2005P-0360
|
| salmon calcitonin products unless certain conditions are met FDA should not approved
|
|
| |
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| ANS 15
|
| HFD-810
|
| Vol #:
|
| 33
|
|
|
|
|
| M 1
|
| memorandum
|
| Vol #:
|
| 33
|
|
|
|
|
| 1994N-0418
|
| Order for Certain Class III Devices, including S&E info
|
|
|
|
|
| C
16
|
| Philips Medical Systems
|
| Vol #:
|
| 23
|
|
|
|
|
| C
17
|
| Meditronic Emergeny Response Systems
|
| Vol #:
|
| 23
|
|
|
|
|
| 1995N-0294
|
| Quality/fill container; common or unusual name regulations
|
|
|
|
|
| C
106
|
| Food Products Association
|
| Vol #:
|
| 5
|
|
| |
|
| 1998P-0221
|
| DIPRIVAN (propofol) Injectable Emulsion
|
|
| | | | | | | | |
|
| |
|
| WDL
1
|
| AstraZeneca Pharmaceuticals LP
|
| Vol #:
|
| 1
|
|
|
|
|
| 1999P-0796
|
| Stay the effective date of approval of ANDAs for Diprivan
|
|
|
|
|
| LET
1
|
| Sicor Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| CH
12
|
| Environmental Defense
|
| Vol #:
|
| 505
|
|
|
|
|
| 2004P-0379
|
| Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0174
|
| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
|
|
|
|
|
| C
4
|
| McGrath & Breitfeller, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
|
| Abbot Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005D-0324
|
| International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0117
|
| P040020 - Acrysof ReSTOR Apodized Diffractive Optic Posterior Chamber Intraocular Lenses, Models MA60D3 and SA60D3, Approved 3/21/05
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0118
|
| P040024 - Restylane Injectable Gel, Approved 3/25/05
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0129
|
| P040018 - ADVIA Centaur HAV IgM ReadyPack Reagents; ADVIA Centaur HAV IgM Quality Control Materials
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0130
|
| P030052 - UroVysion Bladder Cancer Kit
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0151
|
| P930016/S020 - STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS), Approved 3/17/05
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0158
|
| Bayer Healthcare, LLC; Premarket approval for ADVIA Centaur HBc IgM ReadyPack Reagents and ADVIA Centaur HBc IgM Quality Control Materials, P030040
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0159
|
| Ventana Medical Systems, Inc.; Premarket Approval of Ventana Medical Systems' Pathway Anti-c-KIT (9.7) Primary Antibody, P020055
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0160
|
| BioGenex Laboratories, Inc., Premarket Approval of InSite Her-2/neu kit, P040030
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2005M-0191
|
| P040034 - DuraSeal Sealant System
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0192
|
| P040016 - Boston Scientific Corporation Liberte Monorail and Over-the-Wire Coronary Stent Systems
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2005M-0193
|
| P030037 - Rithron-XR Coronary Stent System
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0241
|
| P040026 - Orthospec Extracorporeal Shock Wave Therapy Device, Approved 4/1/05
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0270
|
| P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05
|
|
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
|
|
|
|
|
| C 344
|
| N. Graybill
|
| Vol #:
|
| 11
|
|
|
|
|
| C 345
|
| D. Sprague
|
| Vol #:
|
| 11
|
|
|
|
|
| C 346
|
| A. Wynn
|
| Vol #:
|
| 11
|
|
|
|
|
| C 347
|
| A. Poole
|
| Vol #:
|
| 11
|
|
|
|
|
| C 348
|
| M. DeMase
|
| Vol #:
|
| 11
|
|
|
|
|
| C 349
|
| L. Betlach
|
| Vol #:
|
| 11
|
|
|
|
|
| C 350
|
| J. Koster
|
| Vol #:
|
| 11
|
|
|
|
|
| C 351
|
| R. M. Lowe
|
| Vol #:
|
| 11
|
|
|
|
|
| C 352
|
| C. Randall
|
| Vol #:
|
| 11
|
|
|
|
|
| C 353
|
| R. D. Kline
|
| Vol #:
|
| 11
|
|
|
|
|
| C 354
|
| D. Ely
|
| Vol #:
|
| 11
|
|
|
|
|
| C 355
|
| P. Poe
|
| Vol #:
|
| 11
|
|
|
|
|
| C 356
|
| B. Delaney
|
| Vol #:
|
| 11
|
|
|
|
|
| C 357
|
| A. Aisenberg
|
| Vol #:
|
| 12
|
|
|
|
|
| C
358
|
| Boar's Head Provision Company, Inc.
|
| Vol #:
|
| 12
|
|
|
|
|
| C 359
|
| I. Pohto
|
| Vol #:
|
| 12
|
|
|
|
|
| C 360
|
| G. Sparkman
|
| Vol #:
|
| 12
|
|
|
|
|
| C 361
|
| K. Polliey
|
| Vol #:
|
| 12
|
|
|
|
|
| C 362
|
| C. McMalion
|
| Vol #:
|
| 12
|
|
|
|
|
| C 363
|
| D. Murray
|
| Vol #:
|
| 12
|
|
|
|
|
| 2005N-0345
|
| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
|
|
