| | | | | | | | | | |
|
|
|
|
| Dockets Entered
On September 25, 2003
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1979P-0236
|
| Laser light show
|
|
|
|
|
| 1995D-0349
|
| Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 1998V-0817
|
| Variance for emission delay for BioFlex Professional Laser
|
|
|
|
|
| 2003D-0236
|
| Draft "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;" Availability
|
|
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
|
|
|
|
| 2003E-0448
|
| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944
|
|
|
|
|
| 2003N-0294
|
| Risk Management Plans for Opiate Analgesic Drug
|
|
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
|
|
| 2003P-0121
|
| Enforcing the patent certification requirements in FD&C Act
|
|
|
|
|
| 2003P-0291
|
| Enforce the law and prevent unlaw sale of contact lens
|
|
|
|
|
| 2003P-0436
|
| (ANDA) containing 300 mg Acetaminophen/ 5 mg Hydrocodone, 300 mg Acetaminophen/ 7.5 mg Hydrocodone, 300 mg Acetaminophen/ 10 mg Hydrocodone
|
|
|
|
|
| 2003P-0437
|
| refrain from covering the General and Plastic Surgery Devices panel of the Medical Devices Advsory committee on 10/14/03
|
|
|
|
|
| 2003P-0438
|
| change the regulatory status of prenatal listening devices commonly called "Doppler Fetoscopes" under 21 CFR 5.10
|
|
|
|
|
| 2003P-0450
|
| De Novo Petition for West Nile Virus IgM Capture ELISA
|
|
|
|
|
| 2003V-0440
|
| Laser Light Show
|
|
|
|
|
| 1979P-0236
|
| Laser light show
|
|
|
|
|
| VRA
9
|
| HFZ-300 to Laser Magic Productions
|
| Vol #:
|
| 1
|
|
|
|
|
| 1995D-0349
|
| Immediate Release Solid Oral Dosage Forms;Scale-Up & Postapr
|
|
|
|
|
| RPT
12
Attachment 1,
2
|
| Netzsch Incorporated
|
| Vol #:
|
| 5
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| EXT 1
|
| number not used
|
| Vol #:
|
| 84
|
|
|
|
|
| LET
11044
|
| Quorum Global Limited
|
| Vol #:
|
| 84
|
|
|
|
|
| 1998V-0817
|
| Variance for emission delay for BioFlex Professional Laser
|
|
|
|
|
| EXP
1
Enclosed
|
| Meditech International Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0236
|
| Draft "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;" Availability
|
|
|
| C
5
|
| American Red Cross
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
|
|
|
|
| C
1
Enclosed
|
| The Williamsburg Group
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003E-0448
|
| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944
|
|
|
|
|
| APP 1
|
| LG Life Sciences, Ltd
|
| Vol #:
|
| 1
|
|
|
|
|
| LET 1
|
| U S Patent and Trademark Office
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| 2003N-0294
|
| Risk Management Plans for Opiate Analgesic Drug
|
|
|
|
|
| EMC 3
|
| consumer
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 4
|
| Number not used
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 5
|
| Jeannine M Martin
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
|
|
| C
2
|
| Pharmaceutical Systems, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0121
|
| Enforcing the patent certification requirements in FD&C Act
|
|
|
|
|
| LET
1
|
| HFD-005 to Keller and Heckman, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0291
|
| Enforce the law and prevent unlaw sale of contact lens
|
|
|
|
|
| C 46
|
| Jane Ireland, O.D.
|
| Vol #:
|
| 1
|
|
|
|
|
| C 47
|
| N. William Ritz, O.D.
|
| Vol #:
|
| 1
|
|
|
|
|
| C 48
|
| Dr. Michael Georgescu
|
| Vol #:
|
| 1
|
|
|
|
|
| C 49
|
| Dr. Kruger
|
| Vol #:
|
| 1
|
|
|
|
|
| C 50
|
| Leo J. Santucci, O.D.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0436
|
| (ANDA) containing 300 mg Acetaminophen/ 5 mg Hydrocodone, 300 mg Acetaminophen/ 7.5 mg Hydrocodone, 300 mg Acetaminophen/ 10 mg Hydrocodone
|
|
|
|
|
| ACK 1
|
| Anabolic Laboratories, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0437
|
| refrain from covering the General and Plastic Surgery Devices panel of the Medical Devices Advsory committee on 10/14/03
|
|
|
|
|
| ACK 2
|
| number not used
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0438
|
| change the regulatory status of prenatal listening devices commonly called "Doppler Fetoscopes" under 21 CFR 5.10
|
|
|
|
|
| ACK 2
|
| number not used
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0450
|
| De Novo Petition for West Nile Virus IgM Capture ELISA
|
|
|
|
|
| CP 1
|
| PANBIO Limited
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003V-0440
|
| Laser Light Show
|
|
|
|
|
| ACK 1
|
| HFA-305 to Area 54 DJ Co.
|
| Vol #:
|
| 1
|
|
|
|
|
| ACK 2
|
| Number not used
|
| Vol #:
|
| 1
|
|
