Dockets Entered
On 05/23/2003
Docket # Title
1975N-0183H Health-Care Antiseptic Drug Products for OTC Human Use
1980N-0145B Safety & Efficacy Review for OTC Ophthalmic
Drug Prod.
2001D-0221 Biological Product Deviation Reporting for Licensed Manufact
2002N-0204 Bar Code Label Requirements for human drug products
2002N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]
2003D-0092 Food and Cosmetic Security Guidances
2003N-0134 Team Biologics Program Effectiveness; Public Meeting
2003N-0169 Dental Amalgam; Request for Information
2003P-0140 Refrain from Approving ANDAs for Topical Mupirocin Ointment
2003P-0160 FDA to send letter ruling refusing to approve loratadine
tab
2003P-0196 Switch Nicotrol Inhaler - Prescription - Over the Counter
Status
2003P-0214 Correctlisting-of Quinidine extended-release tablets in
Orange Book
2003P-0216 ANDA for a drug product(1.5 mg levonorgestrel tablet)
in
strength(Plan B 0.75 mg Levonorgestrel tablet) in strength
LET
40 HFD-1 to CTFA & SDA Vol #: 149
C 1 American Academy of Ophthalmology
(AAO) Vol #: 1
1983V-0151 LASER LIGHT SHOW
EXP 9 Precision Projection Systems Inc.
Vol #: 1
1988N-0038 Records & Reports concerning
experience w/ new animal drugs
REF 2 OMB Review Vol #: 3
1996N-0417 CGMP in Mfg. Packing or Holding
Dietary Supplements
C 110 Ralph Fucetola, JD Vol #: 7
C
8 Merck & Co., Inc. Vol #: 1
2002E-0149 Genesis Neurostimulation System,
U.S. Patent No. 4,793,353
LET 3 Advanced Neuromodulation Systems
(ANS) Vol #: 1
C
44 Novartis Consumer Health, Inc. (NCH) Vol #: 13
2002N-0278 Bioterrorism; Prior Notice of
Imported Food Shipments
M 2 HF-1 to Dockets Managemet Branch Vol
#: 14
TR 3 Transcript
for the 04/11/2003 Vol #: 6
C
2 National Restaurant Assn Vol #: 1
2003N-0069 FDA Task Force on Consumer Health
Info for Better Nutrition
EC 61 BROWN SR., GIDEON Vol #: 2
C
1 Gen-Probe, Inc. Vol #: 1
M
1 HFZ-1 Vol #: 1
C
1 Heller, Ehrman, White & McAuliffe, LLP Vol #: 1
C
2 Novartis Consumer Health, Inc. Vol #: 1
CP
1 Pharmacists Planning Services, inc. Vol #: 1
ACK 1 HFA-305 to Mutual Pharmaceutical
Company Vol #: 1
CP
1 Mutual Pharmaceutical Company Vol #: 1
CP
1 HRA Pharma Vol #: 1
2003V-0055 Laser Light Skhow
VRA 1 HFZ-300 to Top-Notch-Entertainment
Vol #: 1
2003V-0131 Laser Light Show
VRA 1 HFZ-300 to Laser Design Productions
Vol #: 1
2003V-0215 Laser Light Show
ACK 1 HFA-305 to U.S. Air Force Research
Laboratory Vol #: 1
VAR 1 US Air Force Research Laboratory
Vol #: 1
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