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| Dockets Entered
On January 30, 2006
Table of Contents
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| Docket #
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| Title
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| 2004E-0021
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| Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
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| 2004P-0513
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| to amend regulation update 'Estrogens Increase The Risk of Endometrial Cancer prescribing info of all strengths of Premarin tablets
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| 2005E-0249
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| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
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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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| 2006A-0041
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| genetic toxicology testing: the Ames Assay, Mouse Lymphoma Assay and the Micronucleus Assay
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| ACK
6
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| HFA-305 to Kleinfeld, Kaplan, & Becker, LLP
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| Vol #:
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| 6
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| ACK
7
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| HFA-305 to Kleinfeld,Kaplan, & Becker, LLP
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| Vol #:
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| 10
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
17188
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| Phytomer, part of Codif International
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| Vol #:
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| 157
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| LET
17189
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| Enzymatic Therapy
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| Vol #:
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| 157
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| LET
17190
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| Enzymatic Therapy
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| Vol #:
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| 157
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| LET
17191
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| Enzymatic Therapy
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| Vol #:
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| 157
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| LET
17192
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| Doctor's Best, Inc.
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| Vol #:
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| 157
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| LET
17193
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| Doctor's Best, Inc.
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| Vol #:
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| 157
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| LET
17194
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| Enzymatic Therapy
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| Vol #:
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| 157
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| LET
17195
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| Enzymatic Therapy
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| Vol #:
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| 157
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| LET
17196
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| Enzymatic Therapy
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| Vol #:
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| 157
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| NPR
1
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| FDA
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| Vol #:
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| 1
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| 2000N-1269
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| Labeling for human prescription drug/Biologic Products
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| BKG
2
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| Background Material
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| Vol #:
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| 7
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| C 36
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| J. Keste
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| Vol #:
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| 3
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| 2004E-0021
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| Patent Extension, XOLAIR (omalizumab), U.S. Patent No. 6,267,958
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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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| 2004P-0513
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| to amend regulation update 'Estrogens Increase The Risk of Endometrial Cancer prescribing info of all strengths of Premarin tablets
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| PDN 1
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| HFD-001 to Beth Rosenshein
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| Vol #:
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| 1
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| 2005E-0249
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| Patent Term Extension Application for Enablex, U.S. Patent No. 5,096,890
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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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| 2005N-0329
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| Designation of New Animal Drugs for Minor Uses or Minor Species
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| C
6
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| American Veterinary Medical Association (AVMA)
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| Vol #:
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| 1
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| SUP
4
Enclosures
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| Department of the Planet Earth
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| Vol #:
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| 3
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| 2005P-0402
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| Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
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| C
1
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| Suicide Awareness Voices of Education (SAVE)
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| Vol #:
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| 5
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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 473
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| B. Chandler
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| Vol #:
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| 6
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| C 474
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| F. Jaddox
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| Vol #:
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| 6
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| C 475
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| L. Edwards
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| Vol #:
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| 6
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| C 476
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| L. Gregorius
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| Vol #:
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| 6
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| C 477
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| G. Crank
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| Vol #:
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| 6
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| C
478
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| Center for Women Policy Studies
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| Vol #:
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| 6
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| C 479
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| S. Gavitt
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| Vol #:
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| 6
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| C 480
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| N. Bogovich
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| Vol #:
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| 6
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| C 481
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| R. Brown
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| Vol #:
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| 6
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| C 482
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| M. Boland
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| Vol #:
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| 6
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| 2006A-0041
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| genetic toxicology testing: the Ames Assay, Mouse Lymphoma Assay and the Micronucleus Assay
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| ACK
1
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| HFA-305 to Litron Laboratories
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| Vol #:
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| 1
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