Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on 12/16/02

TABLE OF CONTENTS

Hyper links are part of the Docket  title - not all dockets/documents are linked

NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
02D-0254 Inhalation Drug Products packaged in Semipermeable container *
02N-0456 Determine Hosp. Proc. for Opened-But-Unused, Single Use Devi *
02P-0396 Suitability Petition for Ivermectin Soft-Chew Anthelmintic *
02P-0416 ANADA dosage form which differs for Ivermectin Equalan Paste *
02P-0423 ANADA for ivermectin/pyrantel different dosage form (molded, *
02P-0429 Abbreviated new animal drug applicationIvermectin for cats *

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2273 American Frozen Institute Vol#: 67

C 2274 National Restaurant Assn Vol#: 67

C 2275 National Diary Council Vol#: 67

C 2276 International Diary Foods Assn Vol#: 67

C 2277 ConAgra Foods Vol#: 67

C 2278 AARP Vol#: 67

C 2279 American Dairy Products Institute (ADPI) Vol#: 67

C 2280 American Bakers Assn (ABA) Vol#: 67

C 2281 Snack Food Assn (SFA) Vol#: 67

C 2282 National Food Processors Assn (NFPA) Vol#: 67

C 2283 National Assn of Margarine Manufacturers Vol#: 67

C 2284 Independent Bakers Assn (IBA) Vol#: 67

98E-1221 Celexa; Patent Term Extension Application,No.4,650,884

LET 3 HFD-005 to US Patent & Trademark Office Vol#: 1

99E-1086 Enbrel, Patent No. 5,712,155

LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1

99E-5114 Patent Extension EVISTA, raloxifene hydrochloride, 4,418,068

LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

C 23 The Dow Chemical Company Vol#: 8

C 24 NV Organon International Vol#: 8

00E-1237 Patent Extension for Relenza (zanamivir), # 5,360,817

LET 3 HFD-005 to US Patent & Trademark Office Vol#: 1

00E-1344 Patent Extension Comtan, No. 5,446,194

LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1

00E-1345 Patent Extension ACTOS, No. 4,687,777

LET 2 HFD-005 to US Patent & Trademark Office Vol#: 1

00E-1347 Patent Extension AVELOX

LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 11553 Kelly Malone Vol#: 349

00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing

MO 27 Bayer Corporation Vol#: 329

MO 28 Animal Health Institute Vol#: 329

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

EMC 5419 Susan Jeanes Vol#: 786

EMC 5420 S Haus Vol#: 786

EMC 5421 F Genniro Vol#: 786

EMC 5422 A Passamante Vol#: 786

EMC 5423 Adriana Totaro Vol#: 786

EMC 5424 Brian McGee Vol#: 786

EMC 5425 Jackie Sowden Vol#: 786

EMC 5426 Amy Todisco Vol#: 786

EMC 5427 Rick Conner Vol#: 786

EMC 5428 Janet Fernandez Vol#: 786

EMC 5429 Janet Fernandez Vol#: 786

EMC 5430 Martin Cibulka Vol#: 786

EMC 5431 Susan Grant Vol#: 786

EMC 5432 Jennifer Morris Vol#: 786

EMC 5433 Geoffrey Friesen Vol#: 786

EMC 5434 Ryan Janus Vol#: 786

EMC 5435 Steve Urban Vol#: 786

EMC 5436 Rae Ann Siewert Vol#: 786

EMC 5437 Rob Gould Vol#: 786

EMC 5438 Jeanne Stancil Vol#: 786

EMC 5439 Nicole Cherok Vol#: 786

EMC 5440 Erika Elmore Vol#: 786

EMC 5441 Anna Blurton Vol#: 786

EMC 5442 Pat Bigelow Vol#: 786

EMC 5443 Daniel Shively Vol#: 786

EMC 5444 Judith Barnes Vol#: 786

EMC 5445 Suzanne Freitag Vol#: 786

EMC 5446 Francine Golembeski Vol#: 786

EMC 5447 Andres Goldschmidt Vol#: 786

EMC 5448 Scott Carpenter Vol#: 786

EMC 5449 Jackie Pomies Vol#: 786

EMC 5450 Susan Dale Vol#: 786

EMC 5451 Lynette Naar Vol#: 786

EMC 5452 Terri Moon Vol#: 786

EMC 5453 Elyse Friedman Vol#: 786

EMC 5454 Clark Andelin Vol#: 786

EMC 5455 James Andelin Vol#: 786

EMC 5456 Larry Johnson Vol#: 786

EMC 5457 Scott Hills Vol#: 786

EMC 5458 Deb Ellis Vol#: 786

01E-0053 Patent Extension for Diphenylmethane diisocyanate, 4,968,514

LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1

01E-0090 Abreva, Patent Extension Application No.4,874,794

LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1

01E-0097 ReFacto, Patent Extension Application No. 4,868,112

LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1

01E-0099 Menicon Z Rigid Contact Lens, Patent Extension Application

LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1

01E-0229 Patent Term Extension Application, PAYLEAN No. 4,690,951

LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1

01E-0362 Patent Term Extension Application, TRAVATAN No. 5,889,052

LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1

01E-0364 Patent Term Extension Application, REMINYL No. 4,663,318

LET 4 HFD-005 to US Patent & Trademark Office Vol#: 1

02D-0254 Inhalation Drug Products packaged in Semipermeable container

C 6 Aradigm Corporation Vol#: 1

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 125 Form Letter 25 Vol#: 3

C 126 Form Letter 19 Vol#: 4

C 127 Kelly Jo Simpson Vol#: 2

C 128 Catherine Miller Vol#: 2

C 129 Brian Tomasik Vol#: 2

C 130 Teresa M. Koon Vol#: 2

C 131 William C. Besselievre Vol#: 2

C 132 Katherine DaSilva Jain Vol#: 2

C 133 Marilyn Carlisle Vol#: 2

C 134 Judith Green, PhD & James L. Kurtz, PhD Vol#: 2

C 135 Bill & Marilyn Voorhies Vol#: 2

C 136 Deborah Jones Vol#: 2

C 137 Elizabeth Smith Vol#: 2

02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

C 36 Patricia McVeigh Vol#: 1

02D-0385 Approval of Labeling for Foods Treated by Irradiation

C 2 M.R. Eucalypfus Vol#: 1

02N-0456 Determine Hosp. Proc. for Opened-But-Unused, Single Use Devi

C 5 MediSISS Vol#: 1

02P-0396 Suitability Petition for Ivermectin Soft-Chew Anthelmintic

PAV 1 HFV-130 to Intervet Inc. Vol#: 1

02P-0416 ANADA dosage form which differs for Ivermectin Equalan Paste

PAV 1 HFV-130 to Highland VetPharma, LLC Vol#: 1

02P-0423 ANADA for ivermectin/pyrantel different dosage form (molded,

PAV 1 HFV-102 to Highland VetPharma, LLC Vol#: 1

02P-0429 Abbreviated new animal drug applicationIvermectin for cats

PAV 1 HFV-130 to Highland VetPharma, LLC. Vol#: 1

02V-0517 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Psyteknology Vol#: 1