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DOCKETS ENTERED on 2/19/03

Docket Number - Title

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
02D-0324 Bioengineered Plants for Use in Humans and Animals *
02D-0468 Manufacture and Labeling of Raw Meat Foods *
02D-0492 Clinical Trials for Therapeutics in Adult Healthy Volunteers *
02N-0417 Applications for FDA Approval to Market a New Drug *
02N-0516 Request for Samples and Protocols;Agency Information Collect *
03P-0064 Withhold Approval of Generic Lovenox (enoxaparin sodium inje *

80N-145B Safety & Efficacy Review for OTC Ophthalmic Drug Prod.

NPR 1 Vol#: 1

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

C 2300 Janet L. Glaspie Vol#: 68

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

CR 1 HFS-820 to Wealth Express Industrial Ltd Vol#: 86

RPT 151 Yat Chau (USA) Inc. Vol#: 86

RPT 152 Hounghwa Global, Inc. Vol#: 86

RPT 153 Amino GmbH Vol#: 110

RPT 154 Pro-Nutrient Technologies, Inc. Vol#: 111

RPT 155 Geranti Pharm Ltd ( McKenna, Long & Aldr Vol#: 113

98N-0645 Device Quality System Warning Letter Draft Pilot

N 3 Vol#: 1

00C-1321 Safe use of mica in contact lenses

NCD 1 Vol#: 1

00E-1239 Patent Extension Rapamune (sirolimus), #5,100,899

N 1 Vol#: 1

00E-1249 Patent Extension Avandia #5,002,953

N 1 Vol#: 1

01E-0225 Patent Term Extension Application, CANCIDAS No. 5,514,650

N 1 Vol#: 1

01E-0403 Patent Term Extension Application; Valcyte No. 6,083,953

N 1 Vol#: 1

01N-0067 Reclassification of Dental Mercury

C 123 William Seachmt Vol#: 18

C 124 Diana L. Seachmt Vol#: 18

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

C 602 Epicyte Pharmaceutical Vol#: 12

C 603 Terence L. Faul Vol#: 13

C 604 Barbara D. Wall Vol#: 13

C 605 Jim Morris Vol#: 13

C 606 North American Millers' Assn Vol#: 13

C 607 Biotechnology Industry Organization (BIO Vol#: 13

C 608 Animal Health Institute (AHI) Vol#: 13

C 609 DuPont Agriculture & Nutrition Vol#: 13

C 610 Stuart Richter Vol#: 13

C 611 P. McBrien Vol#: 13

02D-0468 Manufacture and Labeling of Raw Meat Foods

C 1 Westwood Mink Corp. Vol#: 1

02D-0492 Clinical Trials for Therapeutics in Adult Healthy Volunteers

C 1 Novartis Vol#: 1

02H-0443 Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

ANS 1 LaHaye Center for Advanced Eye Care of L Vol#: 1

02N-0273 Animal Proteins Prohibited in Ruminant Feed

C 50 Peter Johnson Vol#: 4

C 51 Elwood Williams Vol#: 4

C 52 Form Letter 13 Vol#: 5

02N-0280 Objections & Request for a Hearing on a Regulation or Order

N 3 Vol#: 1

02N-0296 Investigational New Drug Regulations;Agency Information Coll

N 3 Vol#: 1

SS 1 Supporting Statement Vol#: 1

02N-0417 Applications for FDA Approval to Market a New Drug

EXT 1 Covington & Burling Vol#: 4

02N-0516 Request for Samples and Protocols;Agency Information Collect

C 1 Merck & Co., Inc. Vol#: 1

03D-0025 Mammography Quality Standards Act

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

03F-0023 Creamers for Use in Alcoholic Beverages

NFL 1 Kerry, Inc. Vol#: 1

03N-0008 Ophthalmic Drug Products for Over-the-Counter Human Use

NFR 1 Vol#: 1

03N-0017 Rick Management Programs on the Practice of Pharmacy

BKG 1 Survey Vol#: 1

N 1 Vol#: 1

03N-0034 FDA Safety Alert/ Public Health Advisory Readership Survey

N 1 Vol#: 1

03P-0064 Withhold Approval of Generic Lovenox (enoxaparin sodium inje

ACK 1 HFA-305 Vol#: 1

CP 1 Aventis Pharmaceuticals Inc. Vol#: 1