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| Dockets Entered
On January 27, 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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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005N-0190
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005N-0327
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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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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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| 2005P-0300
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| Determine that the drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg tablets (NDA 07-935) was voluntarily withdrawn from sale for reasons other than safety or effectiveness
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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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| 2006D-0011
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| Global Harmonization Task Force, Study Groups 1, 2, 3, and 4; New Proposed and Final Documents
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| 2006V-0055
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| Variance for a laser Light Show
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| PSA
5
Attachment
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| Pharmaceutical Distributors Association
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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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| PSA
5
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| Pharmaceutical Distributors Assciation
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| Vol #:
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| 10
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| BKG
1
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| Background Material
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| Vol #:
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| 2
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C 530
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| J. Lesher, DVM
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| Vol #:
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| 45
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| EC
7
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| Dr. Richard Sassetti
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| Vol #:
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| 6
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| EC
8
Attachment
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| Florida Blood Services
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| Vol #:
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| 6
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| EC
9
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| Ms. Mellody Descoteaux
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| Vol #:
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| 6
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| EC
10
Attachment
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| Inland Northwest Blood Center
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| Vol #:
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| 6
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| EC
11
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| South Texas Blood and Tissue Center, San Antonio,
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| Vol #:
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| 6
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| EC
12
Attachment
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| Blood Assurance, Inc.
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| Vol #:
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| 6
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| EC
13
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| Community Blood Services
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| Vol #:
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| 6
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| EC
14
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| Americas Blood Centers
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| Vol #:
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| 6
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| EC
15
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| Winter Haven Hospital
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| Vol #:
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| 6
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| EC
16
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| Blood Assurance, Inc.
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| Vol #:
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| 6
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| EC
17
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| Houchin Blood Bank
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| Vol #:
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| 6
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| EC
18
Attachment
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| Inland Northwest Blood Center
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| Vol #:
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| 6
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| EC
19
Attachment
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| Inland Northwest Blood Center
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| Vol #:
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| 6
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| EC
20
Attachment
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| Inland Northwest Blood Center
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| Vol #:
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| 6
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| EC
21
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| St. Luke's Episcopal Hospital
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| Vol #:
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| 6
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| EC
22
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| Medic Regional Blood Center
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| Vol #:
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| 6
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| EC
23
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| Stanford Blood Center
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| Vol #:
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| 6
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| EC
24
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| Virginia Blood Services
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| Vol #:
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| 6
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| EC
25
Attachment
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| Inland Northwest Blood Center
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| Vol #:
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| 6
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| EC
26
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| Gambro BCT, Inc.
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| Vol #:
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| 6
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| EC
27
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| BloodSource
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| Vol #:
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| 6
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| EC
28
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| Advanced Medical Technology Association
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| Vol #:
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| 6
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| EC
29
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| Blood Systems Inc
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| Vol #:
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| 6
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| EC
30
Attachment
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| Dr. Jeffrey Winters
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| Vol #:
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| 6
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| EC
31
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| University of California, Los Angeles
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| Vol #:
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| 6
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| 2005N-0190
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Export of FDA Regulated Products Export Certificates
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| N
2
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| FDA
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| Vol #:
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| 1
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| LET 6
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| Wyeth Pharmaceuticals
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| Vol #:
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| 2
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| 2005N-0327
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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| N
2
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| FDA
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| Vol #:
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| 1
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| |
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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
5
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| Animal Health Institute (AHI)
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| Vol #:
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| 1
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| C 497
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| K. Maxwell
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| Vol #:
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| 165
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|
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| 2005P-0300
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| Determine that the drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg tablets (NDA 07-935) was voluntarily withdrawn from sale for reasons other than safety or effectiveness
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| LET
1
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| HFD-005 to Amide Pharmaceutical, Inc.
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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 455
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| S. Godwin
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| Vol #:
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| 6
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| C 456
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| L. Speaks
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| Vol #:
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| 6
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| C 457
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| M. Kleinekate
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| Vol #:
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| 6
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| C 458
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| M. Hopkins
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| Vol #:
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| 6
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