| | | | | | | | | | |
|
| |
|
| Dockets Entered
On August 30, 2005
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
|
|
| 2005D-0312
|
| Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
|
|
|
|
|
| 2005M-0339
|
| Premarket Approval for Orthometrix, Inc., Orbasone Pain Relief System (P040039)
|
|
|
|
|
| 2005N-0331
|
| Able Laboratories, Inc.; Withdrawal of Approval of Ten Abbreviated New Drug Applications
|
|
|
|
|
| 2005P-0352
|
| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
|
|
| |
|
| 1999F-4372
|
| National Fisheries Institute and the Louisiana Dep of Agricu
|
|
|
|
|
| BKG
1
|
| Background Information
|
| Vol #:
|
| 9
|
|
| |
|
| 2005D-0312
|
| Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
|
|
|
|
|
| GDL
1
|
| Guideline
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005M-0339
|
| Premarket Approval for Orthometrix, Inc., Orbasone Pain Relief System (P040039)
|
|
|
|
|
| AAV
1
|
| Orthometrix, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0331
|
| Able Laboratories, Inc.; Withdrawal of Approval of Ten Abbreviated New Drug Applications
|
|
|
|
|
| NWL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005P-0352
|
| bioequivalence criteria be applied separately to oxybutynin and its active metabolite, desethyloxbutynin
|
|
|
|
|
| ACK
1
|
| HFA-305 to Ortho-McNeil Pharmaceutical, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Ortho-McNeil Pharmaceutical, Inc.
|
| Vol #:
|
| 1
|
|
