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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 |
|
Enrofloxacin for Poultry: Opportunity for Hearing
|
|
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2002P-0135 |
|
Orally-Administered Levothyroxine Sodium all NDAs &
ANDAs |
|
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2003N-0056 |
|
Patient Examination & Surgeons' Gloves; Test Procedures
|
|
|
2003P-0297 |
|
Exemption from 510(k) process for an Accessory to Electrode
Cable |
|
|
2003P-0298 |
|
Diclofenac Potassium Capusles 25 mg suitable for submission
as ANDA |
|
|
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20-142,mfged by Novartis have been voluntarily withdrawn or wtihheld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 |
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Contents |
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1978N-0036L |
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OTC
Laxative |
|
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ACK 28 |
|
HFA-305 to C.B. Fleet Company |
|
Vol #: |
|
131 |
|
|
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CP 28 |
|
C.B. Fleet Company |
|
Vol #: |
|
131 |
|
|
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1998P-0151 |
|
Introduction Of Downed Cattle Into The Food Supply |
|
|
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|
|
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C 6669 |
|
Kimberlie Wilcox |
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Vol #: |
|
284 |
|
|
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C 6670 |
|
Antoinette Dwinga |
|
Vol #: |
|
284 |
|
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C 6671 |
|
John Michalski |
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Vol #: |
|
284 |
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C 6672 |
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Travis Mapes |
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Vol #: |
|
284 |
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C 6673 |
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Keith Norris |
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Vol #: |
|
284 |
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C 6674 |
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P. Catlin |
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Vol #: |
|
284 |
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|
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C 6675 |
|
Heidi Covelli |
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Vol #: |
|
284 |
|
|
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C 6676 |
|
Marise Pzadic |
|
Vol #: |
|
284 |
|
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C 6677 |
|
Monica Eddy |
|
Vol #: |
|
284 |
|
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C 6678 |
|
Jean A. Lundell |
|
Vol #: |
|
284 |
|
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C 6679 |
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D. L. Fersch |
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Vol #: |
|
284 |
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C 6680 |
|
Don & Sharon Stearns |
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Vol #: |
|
284 |
|
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C 6681 |
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Nelly Chin |
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Vol #: |
|
284 |
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C 6682 |
|
Marlene Campagna |
|
Vol #: |
|
284 |
|
|
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|
|
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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 #:
|
|
284
|
|
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C 6686
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Juliet Kim
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Vol #:
|
|
284
|
|
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C 6687
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Tiffany Kim
|
|
Vol #:
|
|
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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|
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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 #:
|
|
284
|
|
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C 6691
|
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Genevieve Dawson
|
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Vol #:
|
|
284
|
|
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C 6692
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Kathy Westfall
|
|
Vol #:
|
|
284
|
|
|
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2000N-1571
|
|
Enrofloxacin for Poultry: Opportunity for
Hearing
|
|
|
SF 3
|
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HF-1
|
|
Vol #:
|
|
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
|
|
Color Pigments Manufacturers Association, Inc.
|
|
Vol #:
|
|
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
|
|
Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
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C 223
|
|
Irish Exporters Association
|
|
Vol #:
|
|
36
|
|
|
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C 224
|
|
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
|
|
Vol #:
|
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14
|
|
|
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2002P-0135
|
|
Orally-Administered Levothyroxine Sodium all
NDAs & ANDAs
|
|
|
M 7
|
|
HFD-820 Approval of NDA 21-135
|
|
Vol #:
|
|
1
|
|
|
|
2003N-0056
|
|
Patient Examination & Surgeons' Gloves; Test
Procedures
|
|
|
|
|
|
|
|
|
|
|
|
|
C 1
|
|
Kimberly-Clark
|
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Vol #:
|
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1
|
|
|
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2003N-0168
|
|
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
|
|
Agency Information Collection Activities: Proposed Collection;
Comment Request; Biological Products: Reporting of Biological Product
Deviations in Manufacturing
|
|
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N 1
|
|
FDA
|
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Vol #:
|
|
1
|
|
|
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2003N-0273
|
|
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 #:
|
|
1
|
|
|
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2003P-0297
|
|
Exemption from 510(k) process for an Accessory
to Electrode Cable
|
|
|
ACK 1
|
|
HFA-305 to Peter M. Rothenberg, M.D., MA.
|
|
Vol #:
|
|
1
|
|
|
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CP 1
|
|
Peter M. Rothenberg, M.D., MA.
|
|
Vol #:
|
|
1
|
Attachments
|
|
|
2003P-0298
|
|
Diclofenac Potassium Capusles 25 mg suitable for
submission as ANDA
|
|
|
ACK 1
|
|
HFA-305 to The Weinberg Group, Inc.
|
|
Vol #:
|
|
1
|
|
|
|
CP 1
|
|
The Weinberg Group, Inc.
|
|
Vol #:
|
|
1
|
|
|
|
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
|
|
HFA-305 to The Weinberg Group Inc.
|
|
Vol #:
|
|
1
|
|
|
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CP 1
|
|
The Weinberg Group Inc.
|
|
Vol #:
|
|
1
|
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