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DOCKETS ENTERED on 2/28/03

Docket Number - Title

88N-0058 New Animal Drug Regulations *
99P-5198 Request amendment of the definition of milk *
02D-0468 Manufacture and Labeling of Raw Meat Foods *
02D-0509 Intl Conference on Harmonisation/M4 Common Technical Documen *
02N-0178 Canned Tomatoes Deviating from Identity Standard *
02N-0471 Cox-2 Inhibitors: Vioxx and Celebrex *
02N-0532 Nonclinical Datasets; Notice of Pilot Project *
02P-0163 Expedite Over-the-Counter Approval for Desloratidine *
02P-0346 ANDA Amiodarone Hydrochloride Injection 450mg/9ml single use *
02P-0363 NDA 20-560: Fosamax (Alendronate Sodium Tablets) *
02P-0465 ANDA Suitability for Oxycodone & Acetaminophen Tablets *
02P-0473 ANDA for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox *
02P-0480 Amiodarone Hydrochloride Injection , 50mg/mL,9mL vial *
02P-0484 ANDA for Amiodarone Hydrochloride Injection 50 mg/mL *
02P-0505 Labeling nuts & eligible nut containing products reduce risk *
03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach * 75N-0235 POLYVINYL CHLORIDE RESIN

ACK 2 BF-334 to U.S. Enviromental Protection Vol#: 1

ACK 3 BF-334 to Society plastic Industry, Inc. Vol#: 1

88N-0058 New Animal Drug Regulations

WDL 1 Pharmaceutical Distributors Assn Vol#: 1

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

WDL 2 Pharmaceutical Distributors Assn Vol#: 1

99P-5198 Request amendment of the definition of milk

LET 3 HFS-800 to American Dairy Products Insti Vol#: 1

02d-0468-c000005-01-vol1.pdf

01P-0574 Referencing discontinued labeling for Octreotide acetate inj

C 3 Mitchell Berger Vol#: 1

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

C 619 Eligible Vol#: 13

C 620 Pat Helvey Vol#: 13

C 621 Jean M. Gussler Vol#: 13

C 622 Scott Stuckman Vol#: 13

C 623 Dorothea Harrington Vol#: 13

C 624 Gisela S. Ray Vol#: 13

02D-0468 Manufacture and Labeling of Raw Meat Foods

C 5 Assn of American Feed Control Officials Vol#: 1

C 6 Mary Syslo Vol#: 1

C 7 Martha Wunsch Vol#: 1

C 8 Laurleen Scholz Vol#: 1

C 9 Jill Zavis Vol#: 1

C 10 Lidija Thompson Ward Vol#: 1

C 11 Fur Commission USA Vol#: 1

02D-0509 Intl Conference on Harmonisation/M4 Common Technical Documen

C 4 Aventis Pharmaceuticals, Inc. Vol#: 1

C 5 Novartis Vol#: 1

02N-0178 Canned Tomatoes Deviating from Identity Standard

LET 5 HFS-822 to Keller & Heckman Vol#: 1

02N-0471 Cox-2 Inhibitors: Vioxx and Celebrex

C 2 Merck & Co., Inc. Vol#: 1

02N-0532 Nonclinical Datasets; Notice of Pilot Project

LET 2 AstraZeneca Pharmaceuticals, LP Vol#: 1

02P-0163 Expedite Over-the-Counter Approval for Desloratidine

C 1 The 60 Plus Association Vol#: 1

02P-0346 ANDA Amiodarone Hydrochloride Injection 450mg/9ml single use

PAV 1 HFD-600 to Gensia Sicor Pharmaceuticals Vol#: 1

02P-0363 NDA 20-560: Fosamax (Alendronate Sodium Tablets)

PAV 1 HFD-1 to Merck Research Laboratories Vol#: 1

02P-0465 ANDA Suitability for Oxycodone & Acetaminophen Tablets

PAV 1 HFD-600 to Lachman Consultant Services, Vol#: 1

02P-0473 ANDA for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox

PAV 1 HFD-600 to Banner Pharmacaps, Inc. Vol#: 1

02P-0480 Amiodarone Hydrochloride Injection , 50mg/mL,9mL vial

PAV 1 HFD-600 to Bioniche Pharma Group Limited Vol#: 1

02P-0484 ANDA for Amiodarone Hydrochloride Injection 50 mg/mL

PAV 1 HFD-600 to Lachman Consultant Services Vol#: 1

02P-0505 Labeling nuts & eligible nut containing products reduce risk

C 3 Loma Linda University Vol#: 4

03E-0081 Patent Term Extension for ORTHO-EVRA No. 5,876,746

APP 1 Johnson & Johnson Vol#: 1

LET 1 Patent & Trademark Office Vol#: 1

03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach

C 1 PhRMA Working Group Vol#: 1

03V-0080 Laser Light Show

ACK 1 HFA-305 to Sierra Flo Co., LLC Vol#: 1

VAR 1 Sierra Flo Co., LLC Vol#: 1