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| Dockets Entered
On January 3, 2008
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| Docket #
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| Title
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| 1978N-0038
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| Sunscreen Drug Products
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| 1994D-0025
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| Guidelines on the Voluntary Labeling Milk & Milk Products from Cows That Have Not Been Treated with rbSt or rbGH
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| 2005P-0146
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| to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2006P-0390
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| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2008P-0002
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| Request to submit an Abbreviated New Drug Application for Tretinoin Cream in strength of 0.1%.
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| 2008P-0003
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| Determine whether a 1 gm/20 mL (50 mg/mL) presentation of Fluorouracil Injection, USP can be added to Ebewe Pharma's existing ANDA 40-772 Fluorouracil Injection USP 50 mg/mL (500 mg/10mL)
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| 1975N-0183F
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| Topical Antimicrobial Drug Products For OTC Human Use - First Aid
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| LET 10
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| FDA/CDER to Century Pharmaceuticals, Inc.
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| Vol #:
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| 13
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| 1975N-0183H
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| Health-Care Antiseptic Drug Products for OTC Human Use
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| LET 45
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| FDA/CDER to Century Pharmaceuticals, Inc.
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| Vol #:
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| 204
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| 1978N-0038
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| Sunscreen Drug Products
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| C 722
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| IMS, Inc
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| Vol #:
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| 182
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| C 723
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| SPF Consulting Labs, Inc
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| Vol #:
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| 182
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| C 724
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| Suncare Research Laboratories, LLC
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| Vol #:
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| 182
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| C 725
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| Estee Lauder Companies, Inc
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| Vol #:
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| 182
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| EREG 19
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| J. Sass
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| Vol #:
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| 182
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| EREG 20
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| S. Dozier
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| Vol #:
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| 182
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| SUP 36
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| Rapid Precision Testing Laboratories (RPTL)
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| Vol #:
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| 182
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| SUP 37
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| Skin Cancer Foundation
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| Vol #:
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| 182
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| 1994D-0025
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| Guidelines on the Voluntary Labeling Milk & Milk Products from Cows That Have Not Been Treated with rbSt or rbGH
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| ANS 11
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| FDA/Office of Consumer Affairs
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| Vol #:
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| 66
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 21253
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| Bioforce USA
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| Vol #:
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| 183
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| LET 21254
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| Doctors' Research, Inc
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| Vol #:
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| 183
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| LET 21255
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| Doctors' Research, Inc
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| Vol #:
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| 183
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| LET 21256
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| Doctors' Research, Inc
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| Vol #:
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| 183
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| LET 21257
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| Doctors' Research, Inc
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| Vol #:
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| 183
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| LET 21258
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| Isaac Marcum
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| Vol #:
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| 183
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| 2003N-0342
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| Toll-Free Number
for Reporting Adverse Events on Labeling for Human Drug Products
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| NIR 1
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| FDA
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| Vol #:
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| 2
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| 2005P-0146
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| to establish
guidance or regulations providing bioequivalence requirement for oral
locally-acting gastrointestinal(GI) drug products prior to approval
of any generic versions of such drugs
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| PDN 1
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| FDA/CDER to Salix Pharmaceuticals,
Inc.
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| Vol #:
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| 1
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| 2006N-0168
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| Food Labeling: Reference
Daily Intakes & Daily Reference Values
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| EREG 4
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| National Fisheries Institute
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| Vol #:
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| 1
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| 2006N-0454
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| Use of Ozone-Depleting
Substances; Removal of Essential-Use Designations
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| C 4274
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| Russell E. Leong
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| Vol #:
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| 40
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| C 4275
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| Alberto L. Acevedo
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| Vol #:
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| 40
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| C 4276
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| Marjorie Brown
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| Vol #:
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| 40
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| 2006P-0390
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| Order the Church
of Scientology to clearly disclose the potential health hazards inherent
in the use of the E-meter and Scientology's practice of "auditing"
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| C 3
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| Jerry Staton
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling
requirements for eggs sold in the United States
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| C 522
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| L. Grant
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| Vol #:
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| 14
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| C 523
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| K. Gibson
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| Vol #:
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| 14
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| C 524
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| L.Melian
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| Vol #:
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| 14
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| 2007P-0085
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| Adopt Regulations
of General Applicability to all Food Standards that would Permit Deviations
from the Requirements of the Individual Food Standards of Identity
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| C 152
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| Form Letter Count 177
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| Vol #:
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| 7
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| 2008P-0002
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| Request to submit
an Abbreviated New Drug Application for Tretinoin Cream in strength
of 0.1%.
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| ACK 1
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| FDA/DDM to Cobe Chem Labs
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| Vol #:
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| 1
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| CP 1
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| Cobe Chem Labs
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| Vol #:
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| 1
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| 2008P-0003
|
| Determine
whether a 1 gm/20 mL (50 mg/mL) presentation of Fluorouracil Injection,
USP can be added to Ebewe Pharma's existing ANDA 40-772 Fluorouracil
Injection USP 50 mg/mL (500 mg/10mL)
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| ACK 1
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| FDA/DDM to Ebewe Parenta Pharmaceuticals,
Inc.
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| Vol #:
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| 1
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| CP 1
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| Ebewe Pharma
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| Vol #:
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| 1
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