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DOCKETS ENTERED on 04/16/03

76N-0377 Certain Drugs Containing Fluoxymesterone & Ethinyl Estrad

NPH 3 Vol#: 1

NWL 2 Vol#: 1

80N-0280 Vaginal Contraceptive Drug Products-OTC Use

C 51 Citizens Alliance for VD Awareness CAVDA Vol#: 12

C 52 Pacific Institute for Women's Health Vol#: 12

C 53 Apothecus Pharmaceutical Corp (Apothecus Vol#: 12

84N-0102 Orphan Product Designations

LST 100 Cumulative List Through 12/02 Vol#: 5

NAD 17 Vol#: 5

87F-0179 Sucrose polyester-replace fats & oil in food

RPT 5 CSPI Vol#: 41

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3995 Public Citizen & CSPI Vol#: 348

C 3996 Center for Natural Medicine Vol#: 348

C 3997 Virginia Wenzel, R.Ph Vol#: 348

C 3998 Honorable Walter B. Jones et al. Vol#: 348

C 3999 Ephedra Education Council (EEC) Vol#: 349

C 4000 American Nutritional Corp et al. Vol#: 351

96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements

NCR 1 Vol#: 7

98D-0834 Non-Contraceptive Estrogen Class Labeling

C 17 Wyeth Pharmaceuticals, Inc. Vol#: 6

98N-0718 Withdrawal of3 NDA for Estrogen-Androgen Combination Drugs

NWL 2 Vol#: 1

98P-1041 Withdrawn from sale of Tylosterone Tablets

NPH 1 Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing

CS 36 HFA-305 Vol#: 362

MO 42 Center for Veterinary Medicine Vol#: 362

OR 38 HF-3 Vol#: 362

00P-1322 Food Labeling and Allergen Contamination Control

C 526 Ray Gordon Vol#: 29

01D-0368 Submitting Marketing Applications according to ICH/CTD Forma

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

02F-0160 Safe use-Vitamin D3-Calcium-Fortified Fruit Juices

OB 9 King & Spalding LLP Pediatrics Vol#: 1

02N-0275 Bioterrorism Preparedness; Administrative Detention

C 21 CIAJ, Camara de la Industria Alimenticia Vol#: 3

LET 2 HFA-305 to CIAJ Vol#: 3

LET 3 HFA-305 to Non Traditional Products Expo Vol#: 3

MM 8 Summary of 3/10/03 meeting w/Japanese Re Vol#: 3

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

C 155 International Foodservice Distributors Vol#: 12

LET 3 HFA-305-Ministry of Agriculture, Ecuador Vol#: 13

LET 4 HFA-305 to Gobierno de Chile Vol#: 13

LET 5 HFA-305 to Ivannia Chaves Jimenez Vol#: 13

LET 6 HFA-305 to Non Traditional Products Expo Vol#: 13

MM 11 Summary of 3/10/03 meeting w/Japanese Re Vol#: 13

02N-0277 Bioterrorism; Establishment & Maintenance of Records

C 28 International Air Transport Assn (IATA) Vol#: 3

LET 2 HFA-305 to Non Traditional Products Expo Vol#: 3

MM 8 Summary of 3/10/03 meeting w/Japanese Re Vol#: 3

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

LET 3 HFA-305 to Vero Exports, SA de CV Vol#: 14

LET 4 HFA-305-Ministry of Agriculture, Ecuador Vol#: 14

LET 5 HFA-305 to Gobierno de Chile Vol#: 14

LET 6 HFA-305-Federacion Ecuatoriana de Export Vol#: 14

LET 7 HFA-305 to Ivannia Chaves Jimenez Vol#: 14

LET 8 HFA-305 to ANFPA Vol#: 14

LET 9 HFA-305 to Non Traditional Products Expo Vol#: 14

MM 11 Summary of 3/10/03 meeting w/Japanese Re Vol#: 14

02N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

C 1 University of Pennsylvania School of Med Vol#: 1

02P-0450 Withhold Approval of ANDA for Amino Acid Solution Drug Prod.

LET 1 HFD-001 to B. Braun Medical Inc. Vol#: 1

03D-0063 Small Business Qualification Worksheet and Certification

C 1 Oridion Medical Vol#: 1

03N-0016 MedWatch: The FDA Medical Products Reporting Program

C 3 Aventis Pasteur, Inc. Vol#: 1

C 4 National Center for Policy Research for Vol#: 1

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

C 2 APhA, American Pharmacists Assn. Vol#: 1

C 3 National Assn of Chain Drug Stores NACDS Vol#: 1

03P-0159 Venlafaxine Hydrochloride Extended-Release Tablets

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

03P-0160 FDA to send letter ruling refusing to approve loratadine tab

ACK 1 HFA-305 Vol#: 1

CP 1 Genpharm, Inc. of Etobicoke (Canada) Vol#: 1