| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On July 23, 2007
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1999D-2013
|
| Cooperative Manufacturing Arrangements for Licensed
|
|
|
|
|
| 2006P-0405
|
| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
|
|
|
|
|
| 2007D-0118
|
| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
|
|
|
|
|
| 2007D-0135
|
| Guidance for Industry on Testing of Glycerin for Diethylene Glycol
|
|
|
|
|
| 2007M-0285
|
| P040044/S001 - Mynx Vascular Closure System
|
|
|
|
|
| 2007M-0286
|
| P050016 - Cormet Hip Resurfacing System
|
|
|
|
|
| 2007M-0287
|
| P050039 - Novation Ceramic Articulation Hip System
|
|
|
|
|
| 2007M-0288
|
| P930016/S025 - VISX STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan WaveFront System
|
|
|
|
|
| 2007M-0289
|
| P060018 - PRESTIGE Cervical Disc System
|
|
|
|
|
| 2007P-0293
|
| To permit an ANDA Suitability for Fenoprofen Calcium Capsules, 400 mg
|
|
| |
|
| 1999D-2013
|
| Cooperative Manufacturing Arrangements for Licensed
|
|
|
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| N 1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0405
|
| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
|
|
|
|
|
| C 6
|
| Nikesh Ardeshna
|
| Vol #:
|
| 2
|
|
|
|
|
| WDL 1
|
| Number not Used
|
|
|
|
|
|
| |
|
| 2007D-0118
|
| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
|
|
|
|
|
| C 2
|
| Sanofi-aventis
|
| Vol #:
|
| 1
|
|
|
|
|
| C 3
|
| PhRMA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007D-0135
|
| Guidance for Industry on Testing of Glycerin for Diethylene Glycol
|
|
|
|
|
| C 1
|
| Pfizer Global Manufacturing
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007M-0285
|
| P040044/S001 - Mynx Vascular Closure System
|
|
|
|
|
| AAV 1
|
| AccessClosure, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007M-0286
|
| P050016 - Cormet Hip Resurfacing System
|
|
|
|
|
| AAV 1
|
| Corin USA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007M-0287
|
| P050039 - Novation Ceramic Articulation Hip System
|
|
|
|
|
| AAV 1
|
| Exactech, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2007M-0288
|
| P930016/S025 - VISX STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS) and WaveScan WaveFront System
|
|
|
|
|
| AAV 1
|
| AMP/VISX, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2007M-0289
|
| P060018 - PRESTIGE Cervical Disc System
|
|
