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Dockets Entered
On 05/21/2003 Docket # Title 1976N-0377 Certain Drugs Containing Fluoxymesterone & Ethinyl
Estrad 1994P-0036 Req labeling of trans fatty acid & prohibit deceptive
claims 1995N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability 2002N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III] 2003D-0001 Nonclinical Safety Evaluation of Pediatric Drug
Products 2003D-0163 Blood Product Safety-Cases of Suspected SARS 2003P-0107 Synthroid (levothyroxine sodium) Tablets (NDA 21-402) 2003P-0160 FDA to send letter ruling refusing to approve loratadine
tab 2003P-0162 Import Canadian food products that do not meet labeling
regs 1976N-0377 Certain
Drugs Containing Fluoxymesterone & Ethinyl Estrad
HER
3 Syntho Pharmaceutical, Inc. Vol #: 1
1991V-0093 Variance Request for Laser Light
Show
VRA 5 HFZ-300 to Centennial Enterprises
Inc. Vol #: 1 1994P-0036 Req labeling
of trans fatty acid & prohibit deceptive claims
C
2608 HFS-832 to Lyman S. Stanton Vol #: 72 1995N-0304 Ephedrine
Alkaloids: Reports of Adverse Events; Availability
C 4026 Melvin B. Lynn Vol #: 375
EMC 764 Rita Rozek Vol #: 346
EMC 765 Carla I. DiBrino, Psy.D. Vol #:
346
EMC 766 Rita Holgers Vol #: 346
EMC 767 Connie Ballard Vol #: 346
EMC 768 Roger Daley Vol #: 346
EMC 769 Joe Turcott Vol #: 346
EMC 770 No signature Vol #: 346
EMC 771 Brent Pathakis Vol #: 346
EMC 772 Silvina Vol #: 346
EMC 773 Thomas C. Washburn, M.D. Vol #:
346
EMC
774 HerbaSway Laboratories, LLC Vol #: 346
EMC 775 Nadia Landreth Vol #: 346
EMC 776 Glynis P. Wilkins Vol #: 346
1995N-0309 CGMPs for the Production of
Infant Formula
EMC 1 Lisa Jones RN,RLC,IBCLC Vol #: 9
1999D-5435 Draft Guidance for Industry
on Photosafety Testing
NCR 1 FDA Vol #: 1
1999F-4372 National Fisheries Institute
and the Louisiana Dep of Agricu
EMC 432 Jennifer Loch Vol #: 8
EMC 433 Lindsay Mackenzie Vol #: 8
1999F-5321 Food Safety & Inspection
service safe use of ionizing radiai
EMC 335 Jennifer Loch Vol #: 8
EMC 336 Lindsay Mackenzie Vol #: 8
1999F-5322 Ionizing Radiation for the Treatment
of Food
EMC 334 Jennifer Loch Vol #: 6
EMC 335 Lindsay Mackenzie Vol #: 6
1999F-5522 Ionizing radiation /control
of Food-borne pathogens safe use
EMC 337 Jennifer Loch Vol #: 6
EMC 338 Lindsay Mackenzie Vol #: 6
1999N-4282 Biotechnology in the Year 2000
and Beyond; Public Meetings
EMC 3985 Judy Spear Vol #: 514
EMC 3986 Jennifer Loch Vol #: 514
EMC 3987 Gretchyn Bailey Vol #: 514
EMC 3988 Laura Andrews Vol #: 514
EMC 3989 Lindsay Mackenzie Vol #: 514
EMC 3990 Heather Quick Vol #: 514
EMC 3991 Eric Paul Jacobsen Vol #: 514
EMC 3992 Suzanne Ferreira Vol #: 514
1999P-1340 Declared Eternity eau de Parfum
Misbranded
EMC 445 Sal Levinson Vol #: 21
1999P-2630 Establish a Daily Value for
"added sugars"
EMC 480 Elexa Bonogofsky Vol #: 32
2000P-1322 Food Labeling and Allergen Contamination
Control
C 528 William David Forbes Vol #: 30
C 529 Bram Johnson Vol #: 30
C 530 Nina Wilde Vol #: 30
EMC 531 No signature Vol #: 20
EMC 532 No signature Vol #: 20
2001F-0047 Foodborne pathogens in raw-frozen-cooked-partially
cooked
EMC 439 Jennifer Loch Vol #: 8
EMC 440 Lindsay Mackenzie Vol #: 8
2001P-0345 Listing the color additive yellow
#5 for use in food/Drug
EMC 1176 Karen Schmidt Vol #: 5
2002D-0325 Polyvinychloride using Plasticier
di-(2-ethyhexyl)phthalate
EMC 111 Jeanette Keppy Vol #: 3
2002D-0467 Blood products safety cases
known/suspected West Nile Virus
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2002H-0443 Civil Money Penalty Re: LaHaye
Ctr.for Advanced Eye Care
CS 9 HFA-035 Vol #: 1
OR 7 HF-3 Vol #: 1
2002N-0277 Bioterrorism; Establishment
& Maintenance of Records
EMC 20 Ministry of Agriculture of Ecuador
Vol #: 4
EMC 21 Aquamar S.A. Vol #: 4
2002N-0486 Prescription Drug Marketing
Act of 1987
N 2 FDA Vol #: 1 2002N-0528 Risk
Management Workshop, April 9-11, 2003 [PDUFA III]
EMC 18 Bill Campbell PhD, Judith Kramer
MD MS Vol #: 3
EMC
19 McKesson Corporation Vol #: 3
EMC
20 Pharmacovigilance & Risk Management Inc. Vol #: 3
EMC
21 First Generic Trust Vol #: 3
LST
1 List of Attendees for 04/09-11/2003 public workshop Vol #: 3
TR
1 Transcript of the 04/09/2003 Workshop Vol #: 4
TR
2 Transcript of the 04/10/2003 Workshop Vol #: 5
2002P-0163 Expedite Over-the-Counter Approval
for Desloratidine
EMC 3 Chuck Gordon Vol #: 1
EMC 4 Mary McLemore Vol #: 1 2003D-0001 Nonclinical
Safety Evaluation of Pediatric Drug Products
EMC 1 Merck & Co., Inc.
Vol #: 1 2003D-0163 Blood
Product Safety-Cases of Suspected SARS
C 6
Lane Memorial Blood Bank Vol #: 1
2003N-0069 FDA Task Force on Consumer Health
Info for Better Nutrition
EC 59 Lam-Murphy, Barbara Vol #: 2
EMC 3 Sharon Hankey Vol #: 1
2003N-0134 Team Biologics Program Effectiveness;
Public Meeting
APE 43 BioWorld Today Vol #: 1
APE 44 Jamie Wolszon Vol #: 1 2003P-0107 Synthroid
(levothyroxine sodium) Tablets (NDA 21-402)
ACK 2 HFA-305 to Abbott Laboratories Vol
#: 1
PSA
1 Abbott Laboratories Vol #: 1 2003P-0160 FDA to
send letter ruling refusing to approve loratadine tab
2003P-0162 Import
Canadian food products that do not meet labeling regs
LET
1 J.M. Investments, Inc. D.B.A. Lucky Vol #: 1
2003V-0125 Infrared Laser Aiming Device
VRA 1 HFZ-300 to Insight Technology, Inc.
Vol #: 1
2003V-0155 Laser light show
VRA 1 HFZ-300 to Mojo-Laser Vol #: 1
2003V-0208 Laser Light Show
ACK 1 HFA-305 to Laser Entertainment SRL
Vol #: 1
VAR 1 Laser Entertainment SRL Vol #: 1
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