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DOCKETS ENTERED on September 27, 2002

TABLE OF CONTENTS

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89P-0399 ANDA Suitability re: Carbamazepine Suspension 200 mg/5 ml *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
01P-0396 Request that FDA ban the production and sale of all ephedra *
02N-0209 Governing First Amendment Case Law *
02P-0139 Arava (leflunomide;Aventis) remove from the market *
02P-0141 ANDA for 1.2 mg estropipate (1.2 mg sodium estrone sulfate) *
02P-0148 ANDA for Fenofibrate Tablets (Tricor) *
02P-0270 Suitability Petition for Hydrocodone Bitartrate/Ibuprofen 5 *
02P-0424 ANDA for Loperamide Hydrochloride 1 mg Soft Gelatin Capsules *

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

REF 1 OMB Review on 12/3/99 Vol#: 7

89P-0399 ANDA Suitability re: Carbamazepine Suspension 200 mg/5 ml

ACK 1 HFA-305 Vol#: 1

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

REF 1 OMB Review on 12/3/99 Vol#: 9

95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t

C 425 Media Services, Inc. Vol#: 13

C 426 Jim & Joyce Berry Vol#: 13

C 427 Mrs. Carol J. Rpoer Vol#: 13

C 428 Patricia A. Proudman Vol#: 13

C 429 Dianne Hicks et al Vol#: 13

C 430 Christine L. O'Rourke Vol#: 13

C 431 Sherrie L. Nielsen Vol#: 13

C 432 Cynthia Cobb Vol#: 13

C 433 Caryn J. Hayden Vol#: 13

C 434 Lee E. Heller, Ph.D. Vol#: 13

C 435 Mr. & Mrs. Roger Adams Vol#: 13

C 436 Marilyn E. Harmer Vol#: 13

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 106 Power Africa, Inc. Vol#: 80

RPT 107 Power Africa, Inc. Vol#: 80

RPT 108 Power Africa, Inc. Vol#: 80

RPT 109 Power Africa, Inc. Vol#: 80

RPT 110 OmegaTech, Inc. Vol#: 81

RPT 111 Soft Gel Technologies, Inc. Vol#: 80

RPT 112 PharmaSe, Inc. Vol#: 80

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

REF 2 OMB Review on 7/24/02 Vol#: 201

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

EAPE58 FDA CVM Vol#: 4

EAPE59 FDA CVM HFV-157 Vol#: 4

EAPE60 Animal Health Institute Vol#: 4

EAPE61 FDA/Center for Veterinary Medicine Vol#: 4

EAPE62 CVM Vol#: 4

EAPE63 FDA,CVM Vol#: 4

EAPE64 Abbott Laboratories Vol#: 4

EAPE65 FDA/CVM/OM Vol#: 4

EAPE66 Alliance for the Prudent Use of Antibiot Vol#: 4

EAPE67 APUA Vol#: 4

EAPE68 Animal Health Institute Vol#: 4

98N-0750 Electronic Reporting of Postmarket Adverse Drug Reactions

REF 1 OMB Review on 11/5/98 Vol#: 1

99P-5106 Identify Sources of Natural Flavorings

C 18 Trent Bower Vol#: 2

00N-1463 Labeling Requirements for Systemic Antibacterial Drug Produc

REF 1 OMB Review on 9/19/00 Vol#: 1

01P-0120 Ban Unsafe IV Catheters and other Devices

C 28 Lorraine M. Harkavy Vol#: 1

01P-0396 Request that FDA ban the production and sale of all ephedra

C 4 Med-Tox Group Vol#: 1

C 5 Thomas N. Tiedt, Ph.D. Vol#: 1

02N-0209 Governing First Amendment Case Law

SUP 2 SureBeam Corp. Vol#: 23

02P-0139 Arava (leflunomide;Aventis) remove from the market

LET 1 HFD-1 to Public Citizen Vol#: 1

02P-0141 ANDA for 1.2 mg estropipate (1.2 mg sodium estrone sulfate)

PAV 1 HFD-600 to Women First Healthcare Vol#: 1

02P-0148 ANDA for Fenofibrate Tablets (Tricor)

PAV 1 HFD-600 to Lavender Consulting Services Vol#: 1

02P-0270 Suitability Petition for Hydrocodone Bitartrate/Ibuprofen 5

PAV 1 HFD-600 to SciRegs Consulting Vol#: 1

02P-0424 ANDA for Loperamide Hydrochloride 1 mg Soft Gelatin Capsules

ACK 1 HFA-305 Vol#: 1

CP 1 Banner Pharmacaps Inc. Vol#: 1

02V-0425 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 MGM Grand Hotel Vol#: 1