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| Dockets Management
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| Dockets Entered On
July 28, 2006
Table of Contents
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| Docket #
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| Title
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| 1999E-5113
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| Patent Extension: Clinacox (diclazuril), #4,631,278
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| 2003E-0418
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| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005E-0250
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| Patent Term Extension Application for NSURE U.S. Patent No. 4,600,706
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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| 2006N-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2006P-0093
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| ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128-409, Merial LTD.,
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0159
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| Recommend changes to NIST Handbook 44 (through the NIST and NCWM), and the U.S. Pharmacopeia to reflect the required pharmacy quality control practices
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| 2006P-0280
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| Emergency Request to Open Blood Products Advisory Committee Meeting on Friday, July 14, 2006
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| 2006P-0287
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| determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| 2006P-0300
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| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
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| 1999E-5113
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| Patent Extension: Clinacox (diclazuril), #4,631,278
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| LET 5
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| FDA/CDER to U.S. Patent and Trademark Office
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| 1
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| 2003E-0418
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| Emend (Aprepitant), Patent Term Extension Application; U.S. Patent No. 5,719,147
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| LET 4
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| FDA/CDER to U.S. Patent and Trademark Office
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| 1
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC 18
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005E-0250
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| Patent Term Extension Application for NSURE U.S. Patent No. 4,600,706
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| LET 2
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| FDA/CDER to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 17953
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| D. Briggs
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| Vol #:
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| 193
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| C 17954
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| S. Hodas
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| Vol #:
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| 193
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| C 17955
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| R. Morse
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| Vol #:
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| 193
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| C 17956
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| L. Semple
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| Vol #:
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| 193
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| C 17957
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| T. Mardorf
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| Vol #:
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| 193
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| C 17958
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| E. Kelley
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| Vol #:
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| 193
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| C 17959
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| S. Haughy
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| Vol #:
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| 193
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| C 17960
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| M. McCravy
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| Vol #:
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| 193
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| C 17961
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| C. Skousen
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| Vol #:
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| 193
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| C 17962
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| C. Lambert
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| Vol #:
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| 193
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| C 17963
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| L. Trounig
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| Vol #:
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| 193
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| C 17964
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| S. Minor
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| Vol #:
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| 193
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| EC 33257
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| Ms. Patti Shaffner,LDH
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| Vol #:
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| 142
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| EC 33258
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| Ms. Sandra M. Goguen
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| Vol #:
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| 142
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| 2006E-0189
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| Patent Extension Application for IPLEX (mecasermin rinfabate rDNA origin injection), U.S. Patent No. 5,681,818
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| LET 4
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| FDA/CDER to U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0261
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| Patent Extension Application for EXJADE (deferasirox), U.S. Patent No. 6,465,504
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| LET 2
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| FDA/CDER to U.S. Patent and Tradmark Office
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| Vol #:
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| 1
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| 2006N-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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| EC 2
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| OPTN/UNOS
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| Vol #:
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| 1
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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| EC 1
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| Tracon Consultants Ltd.
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| Vol #:
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| 1
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| EC 2
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| Tracon Consultants Ltd.
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| Vol #:
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| 1
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| 2006P-0093
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| ECOAnimal Health seeks permission to file an ANADA for a generic equivalent of the innovator product Ivomec (ivermectin) injection for cattle and swine , 1% sterile solution NADA 128-409, Merial LTD.,
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| EC 670
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| National Organization for Women
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| Vol #:
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| 3
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| EC 671
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| Ms. Judy Trompeter
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| Vol #:
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| 3
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| EC 672
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| Ms. Gayle` Kaplan
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| Vol #:
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| 3
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| EC 673
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| Ms. Kelly Angel
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| Vol #:
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| 3
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| EC 674
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| Ms. Alison Spears
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| Vol #:
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| 3
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| 2006P-0159
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| Recommend changes to NIST Handbook 44 (through the NIST and NCWM), and the U.S. Pharmacopeia to reflect the required pharmacy quality control practices
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| PDN 1
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| FDA/CDER to James Q. Maloy
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| Vol #:
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| 1
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| 2006P-0209
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| Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml
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| EC 12
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0280
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| Emergency Request to Open Blood Products Advisory Committee Meeting on Friday, July 14, 2006
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| WDL 1
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| Public Citizen Litigation Group
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| Vol #:
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| 1
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| 2006P-0287
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| determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0299
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| Determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials (NDA #21-492 has been withdrawn for safety or effectiveness reasons
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006P-0300
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| ANDA Suitability for Glycoprrolate Tablets, USP 1.5 mg
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| ACK 1
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| FDA/DDM to Lachman Consultant Services Inc.
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| Vol #:
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| 1
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| CP 1
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| Lachman Consultant Services Inc.
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| Vol #:
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| 1
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