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Dockets
Entered On June 30, 2003
Table of Contents |
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Docket # |
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Title |
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OTC Laxative |
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2000N-1571 |
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Enrofloxacin for Poultry: Opportunity for Hearing
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2002P-0135 |
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Orally-Administered Levothyroxine Sodium all NDAs &
ANDAs |
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2003N-0056 |
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Patient Examination & Surgeons' Gloves; Test Procedures
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2003P-0297 |
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Exemption from 510(k) process for an Accessory to Electrode
Cable |
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2003P-0298 |
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Diclofenac Potassium Capusles 25 mg suitable for submission
as ANDA |
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2003P-0300 |
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Cataflam (diclofenac potassium) Tablets 25 mg (NDA
20-142,mfged by Novartis have been voluntarily withdrawn or wtihheld
from sale for safety or effectiveness reasons |
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| Contents |
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1978N-0036L |
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OTC
Laxative |
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ACK 28 |
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HFA-305 to C.B. Fleet Company |
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Vol #: |
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131 |
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CP 28 |
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C.B. Fleet Company |
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Vol #: |
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131 |
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1998P-0151 |
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Introduction Of Downed Cattle Into The Food Supply |
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C 6669 |
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Kimberlie Wilcox |
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Vol #: |
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284 |
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C 6670 |
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Antoinette Dwinga |
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Vol #: |
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284 |
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C 6671 |
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John Michalski |
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Vol #: |
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284 |
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C 6672 |
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Travis Mapes |
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Vol #: |
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284 |
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C 6673 |
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Keith Norris |
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Vol #: |
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284 |
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C 6674 |
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P. Catlin |
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Vol #: |
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284 |
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C 6675 |
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Heidi Covelli |
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Vol #: |
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284 |
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C 6676 |
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Marise Pzadic |
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Vol #: |
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284 |
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C 6677 |
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Monica Eddy |
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Vol #: |
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284 |
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C 6678 |
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Jean A. Lundell |
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Vol #: |
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284 |
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C 6679 |
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D. L. Fersch |
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Vol #: |
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284 |
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C 6680 |
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Don & Sharon Stearns |
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Vol #: |
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284 |
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C 6681 |
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Nelly Chin |
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Vol #: |
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284 |
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C 6682 |
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Marlene Campagna |
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Vol #: |
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284 |
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C 6683
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Toni Siegrist
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Vol #:
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284
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C 6684
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Veronica Proksch
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Vol #:
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284
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C 6685
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Sarah O' Farrell
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Vol #:
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284
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C 6686
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Juliet Kim
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Vol #:
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284
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C 6687
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Tiffany Kim
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Vol #:
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284
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C 6688
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Lodi McClellan
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Vol #:
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284
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C 6689
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Nancy Kim
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Vol #:
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284
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C 6690
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Sayaka Rifu
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Vol #:
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284
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C 6691
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Genevieve Dawson
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Vol #:
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284
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C 6692
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Kathy Westfall
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Vol #:
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284
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2000N-1571
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Enrofloxacin for Poultry: Opportunity for
Hearing
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SF 3
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HF-1
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Vol #:
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378
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SF 4
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HF-1
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Vol #:
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378
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2002N-0275
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Bioterrorism Preparedness; Administrative Detention
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C 24
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Irish Exporters Association
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Vol #:
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3
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C 25
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Color Pigments Manufacturers Association, Inc.
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Vol #:
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1
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MM 9
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FDA & Sandler, Travis & Rosenberg, Flegenheimer
International, Inc, Produce Broker, FedE
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Vol #:
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3
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2002N-0276
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Bioterrorism Preparedness; Registration of Food Facilities
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C 159
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Irish Exporters Association
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Vol #:
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13
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C 160
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North American Tomato Trade Work Group
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Vol #:
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13
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MM 13
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FDA & Sandler, Travis & Rosenberg, FedEx, Flegenheimer
International, Inc., Produce Brok
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Vol #:
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13
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2002N-0277
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Bioterrorism; Establishment & Maintenance of Records
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C 33
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Irish Exporters Association
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Vol #:
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8
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MM 9
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FDA & Sandler, Travis & Rosenberg, FedEx, Flegenheimer
International, Inc., Produce Brok
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Vol #:
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8
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2002N-0278
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Bioterrorism; Prior Notice of Imported Food Shipments
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C 223
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Irish Exporters Association
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Vol #:
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36
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C 224
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North American Tomato Trade Work Group
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Vol #:
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25
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MM 12
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FDA & Sandler, Travis & Rosenberg, Flegenheimer
International, Produce Broker
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Vol #:
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14
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2002P-0135
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Orally-Administered Levothyroxine Sodium all
NDAs & ANDAs
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M 7
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HFD-820 Approval of NDA 21-135
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Vol #:
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1
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2003N-0056
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Patient Examination & Surgeons' Gloves; Test
Procedures
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C 1
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Kimberly-Clark
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Vol #:
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1
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2003N-0168
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July 31, 2003 Public Meeting on Consumer Medication Information
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APE 1
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Public Citizen's Health Research Group
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Vol #:
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2
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APE 2
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Sara J. Doruska, Pharm.D.
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Vol #:
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2
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APE 3
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American Society of Health-System Pharmacists
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Vol #:
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2
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APE 4
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PhRMA
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Vol #:
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2
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APE 5
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National Council on Patient Information & Education (NCPIE)
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Vol #:
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2
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APE 6
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National Association of Chain Drug Stores
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Vol #:
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2
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2003N-0268
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Agency Information Collection Activities: Proposed Collection;
Comment Request; Biological Products: Reporting of Biological Product
Deviations in Manufacturing
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N 1
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FDA
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Vol #:
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1
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2003N-0273
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Agency Information Collection Activities; Proposed Collection;
Comment Request; Research Study Complaint Form
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N 1
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FDA
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Vol #:
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1
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2003P-0297
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Exemption from 510(k) process for an Accessory
to Electrode Cable
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ACK 1
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HFA-305 to Peter M. Rothenberg, M.D., MA.
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Vol #:
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1
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CP 1
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Peter M. Rothenberg, M.D., MA.
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Vol #:
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1
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Attachments
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2003P-0298
|
|
Diclofenac Potassium Capusles 25 mg suitable for
submission as ANDA
|
|
|
|
ACK 1
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HFA-305 to The Weinberg Group, Inc.
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Vol #:
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1
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CP 1
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The Weinberg Group, Inc.
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Vol #:
|
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1
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|
|
|
|
|
2003P-0300
|
|
Cataflam (diclofenac potassium) Tablets 25 mg
(NDA 20-142,mfged by Novartis have been voluntarily withdrawn or wtihheld
from sale for safety or effectiveness reasons
|
|
|
|
ACK 1
|
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HFA-305 to The Weinberg Group Inc.
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Vol #:
|
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1
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CP 1
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The Weinberg Group Inc.
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Vol #:
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1
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