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| Dockets Entered
On February 2, 2006
Table of Contents
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| Docket #
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| Title
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| |
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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| |
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| |
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| 2004E-0394
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| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
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| |
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| 2004E-0445
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| Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
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| 2004N-0366
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| Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| 2004P-0512
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| Health Claim Petition for Soluble Fiber from Barley
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| 2005D-0438
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| Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| |
|
|
| 2005E-0233
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| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
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| |
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| 2005E-0247
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| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
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| |
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| 2005E-0258
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| Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
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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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| |
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| |
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| |
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| 2005N-0428
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| Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requ
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| 2005P-0096
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| ANDA 77-421 Loratadine Syrup- Hives relief
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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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| 2005P-0433
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| Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
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| 2005P-0452
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| FDA's decisions concerning approvals of generic versions of atorvastatin
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| 2005P-0487
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| Require manufacturers to stop using xylene, toluene, and dibutyl phthalate in nail polish marketed for children under the age of 14.
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| 2005P-0496
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| ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
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| 2005P-0498
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| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
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| 2006P-0001
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| Date of Approval for Lunesta (Eszopiclone) Tablets
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| 2006P-0002
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| Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)
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| 2006P-0007
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| Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
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| 2006P-0060
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| ANADA for Unibute Granules 200 mg phenylbutazone per g of of granules instant of paste
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| 1998P-0724
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| Prohibition of Cochineal Extract and Carmine Color Additives
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| EC
1
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| Mr. Sean Larson
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| Vol #:
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| 1
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| EC
2
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| Ms. Kristina Sularz
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| Vol #:
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| 1
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| EC
3
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| Ms. Shannon Weisenberg
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| Vol #:
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| 1
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| | | | | | | | |
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| EC
4
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| Mr. Kevin Heckman
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| Vol #:
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| 1
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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| EC
1
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| Dabur Research Foundation
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| Vol #:
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| 1
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| EC
2
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| Dabur Research Foundation
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| Vol #:
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| 1
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| EC
3
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| Ms. Roberta Smith
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| Vol #:
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| 1
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| EC
4
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| Mr. Robert Bowolick
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| Vol #:
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| 1
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| EC
5
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| individual consumer
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| Vol #:
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| 1
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| |
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| C 5
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| J. Fitch, M.D., P.A
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| Vol #:
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| 3
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| 2004E-0394
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| Patent Extension for ALOXI (palonosetron hydrochloride) injection, U.S. Patent No. 5,202,333
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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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| |
|
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| 2004E-0445
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| Patent Extension for HUMIRA (adalimumab), U.S. Patent No. 6,090,382
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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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| 2004N-0366
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| Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies
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| C
1
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| Plasma Protein Therapeutics Association (PPTA)
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| Vol #:
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| 1
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| 2004N-0556
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| Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
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| C 2
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| J. Fitch, M.D., P.A.
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| Vol #:
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| 4
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| 2004P-0512
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| Health Claim Petition for Soluble Fiber from Barley
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|
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| EC
1
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| Dsystem
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| Vol #:
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| 10
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| |
|
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| 2005D-0438
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| Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
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| EC
1
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| ACAAI
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| Vol #:
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| 1
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| EC
1
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| Mr. Bryan Wagner
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| Vol #:
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| 1
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| EC
2
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| Mr. Bryan Wagner
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| Vol #:
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| 1
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| |
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| |
|
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| EC
1
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| Bien Padre Foods
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| Vol #:
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| 1
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| EC
2
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| Idea Food Inc.
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| Vol #:
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| 1
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| EC
3
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| Mrs. Melanie Fisher
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| Vol #:
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| 1
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| EC
4
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| Mr. Larry Hasenour
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| Vol #:
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| 1
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| | | | | | | | |
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| |
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| EC
1
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| Mrs. angela hart
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| Vol #:
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| 1
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| EC
2
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| Mrs. Frances Ablondi
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| Vol #:
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| 1
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| EC
3
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| individual
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| Vol #:
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| 1
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| EC
4
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| Ms. Tarra Stocker
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| Vol #:
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| 1
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| EC
5
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| Mr. Gregg Stocker
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| Vol #:
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| 1
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| EC
6
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| Home
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| Vol #:
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| 1
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| |
|
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| 2005E-0233
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| Patent Extension for OMACOR (EPA ethyl ester and DHA ethyl ester), U.S. Patent No. 5,502,077
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| |
|
|
| N
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
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| 2005E-0247
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| Patent Term Extension Application for Omacor, U.S. Patent No. 5,698,594
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| |
|
|
| N
1
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| FDA
|
| Vol #:
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| 1
|
| |
|
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| 2005E-0258
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| Patent Term Extension Application for OMACOR, U.S. Patent No. 5, 656,667
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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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|
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| EC
2
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| Keep Antibiotics Working
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| Vol #:
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| 1
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| EC
3
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| American Veterinary Medical Association
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| Vol #:
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| 1
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| EC
4
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| American Veterinary Medical Association
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| Vol #:
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| 1
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| |
|
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| EC
431
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| Genetic Alliance
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| Vol #:
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| 10
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| |
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| EC
432
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| Mrs. Debra Scofield
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| Vol #:
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| 10
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| |
|
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| EC
433
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| Ms. Denise Munsterman
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| Vol #:
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| 10
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| |
|
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| 2005N-0374
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| Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
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| |
|
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| C 4
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| A. Smith
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| Vol #:
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| 1
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| |
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| EC
9
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| Mr. Richard M. Kerestan Kerestan
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| Vol #:
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| 1
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| |
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| EC
10
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| American Pharmacists Association
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| Vol #:
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| 1
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| |
|
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| EC
11
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| Mr. Mike Kiernan
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| Vol #:
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| 1
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| |
|
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| EC
12
|
| Mr. D Kusta
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| Vol #:
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| 1
|
| |
|
|
| 2005N-0428
|
| Distribution of Blood Derivatives by Registered Blood Establishments that Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requ
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|
|
|
|
|
|
|
|
| NPR
1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2005P-0096
|
| ANDA 77-421 Loratadine Syrup- Hives relief
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 524
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| S. Castleman
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| Vol #:
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| 6
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| |
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| C 525
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| N. Bergfeld
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| Vol #:
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| 6
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| |
|
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| C 526
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| S. Mawhinney
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| Vol #:
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| 6
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| |
|
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| C 527
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| K. DuBois
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| Vol #:
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| 6
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| |
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| C 528
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| J. Durni
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| Vol #:
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| 6
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| |
|
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| C 529
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| P. Sluder
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| Vol #:
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| 6
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| |
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| C 530
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| J. Ledebahr
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| Vol #:
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| 6
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| C 531
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| V. Curtis
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| Vol #:
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| 6
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| C 532
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| L. Switter
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| Vol #:
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| 6
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| |
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| C 533
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| L. Newby
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| Vol #:
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| 6
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| |
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| C 534
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| P. Thomas
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| Vol #:
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| 6
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| |
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| C 535
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| C. Green
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| Vol #:
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| 6
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| |
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| C 536
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| K. Samelian
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| Vol #:
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| 6
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| |
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| C 537
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| K. Samelian
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| Vol #:
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| 6
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| |
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| C 538
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| K. Matthews
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| Vol #:
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| 6
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| |
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| C 539
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| M. Nagel
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| Vol #:
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| 6
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| |
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| C 540
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| L. Ells
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| Vol #:
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| 6
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| |
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| C 541
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| K. Humphrey
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| Vol #:
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| 6
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| |
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| C 542
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| J. Massara
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| Vol #:
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| 6
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| |
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| C 543
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| D. White
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| Vol #:
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| 6
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| |
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| EC
454
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| Dr. steven sinclair
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| Vol #:
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| 7
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| |
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| EC
455
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| Mrs. Jill Oman
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| Vol #:
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| 7
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| |
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| EC
456
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| Clinical Apothecaries Pharmacy
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| Vol #:
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| 7
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| |
|
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| EC
457
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| Plante and Moran
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| Vol #:
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| 7
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| |
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| EC
458
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| Mrs. Jane Citizen
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| Vol #:
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| 7
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| |
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| EC
459
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| Mrs. Brenda Blackburn
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| Vol #:
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| 7
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| |
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| EC
460
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| Mr. Eric Dietrich
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| Vol #:
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| 7
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| |
|
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| EC
461
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| Mrs. Rhonda Howell
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| Vol #:
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| 7
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| |
|
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| EC
462
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| Ms. Jone Franco
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| Vol #:
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| 7
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| |
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| EC
463
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| Mrs. Sharon Howell
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| Vol #:
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| 7
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| |
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| EC
464
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| Caring Medical
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| Vol #:
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| 7
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| |
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| EC
465
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| Ms. Marion Hauser
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| Vol #:
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| 7
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| |
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| EC
466
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| Dr. Audrey Boxwell
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| Vol #:
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| 7
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| |
|
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| EC
467
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| Sonrisa Renewal Center--Spirit-Creativity-Integrat
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| Vol #:
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| 7
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| |
|
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| EC
468
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| Longevity Medical Clinic
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| Vol #:
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| 7
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| | | | | | | |
|
| |
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| EC
469
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| Mrs. Carol Burson
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| Vol #:
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| 7
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| |
|
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| EC
470
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| University of Louisville
|
| Vol #:
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| 7
|
| |
|
|
| EC
471
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| Mrs. Clare Baros
|
| Vol #:
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| 7
|
| |
|
|
| EC
472
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| Ms. Sue Hackenmiller
|
| Vol #:
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| 7
|
| |
|
|
| EC
473
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| Mrs. Terri Winters
|
| Vol #:
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| 7
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| |
|
|
| EC
474
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| Individual Consumer
|
| Vol #:
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| 7
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| |
|
|
| EC
475
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| Mrs. Sarah Rose
|
| Vol #:
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| 7
|
| |
|
|
| EC
476
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| Mrs. Beth Kruse
|
| Vol #:
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| 7
|
| |
|
|
| EC
477
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| Mrs. Martha Lovejoy
|
| Vol #:
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| 7
|
| |
|
|
| EC
478
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| Dr. Richard Shames MD
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| Vol #:
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| 7
|
| |
|
|
| EC
479
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| Mrs. Patricia Reveille
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| Vol #:
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| 7
|
| |
|
|
| EC
480
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| Mrs. Diane Cabiness
|
| Vol #:
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| 7
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| |
|
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| EC
481
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| peggy fishman, md psc
|
| Vol #:
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| 7
|
| |
|
|
| EC
482
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| Mr. Edward Dannhaus
|
| Vol #:
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| 7
|
| |
|
|
| EC
483
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| Mrs. Sandy Broussard
|
| Vol #:
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| 7
|
| |
|
|
| EC
484
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| Ms. Deborah Hughes
|
| Vol #:
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| 7
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| |
|
|
| EC
485
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| Mrs. Holly Collins-Doan
|
| Vol #:
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| 7
|
| |
|
|
| EC
486
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| Ms. Kendal Keyes
|
| Vol #:
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| 7
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| |
|
|
| EC
487
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| Mrs. Cristina Vasquez
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| Vol #:
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| 7
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| |
|
|
| EC
488
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| Mrs. Edath Yoffee
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| Vol #:
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| 7
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| |
|
|
| EC
489
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| Mr. Jeff McGeary
|
| Vol #:
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| 7
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| |
|
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| EC
490
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| Ms. Catherine Granger
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| Vol #:
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| 7
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| |
|
|
| EC
491
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| Mrs. Diane Cabiness
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| Vol #:
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| 7
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| |
|
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| EC
492
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| Ms. Stephanie Kilpatrick
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| Vol #:
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| 7
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| |
|
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| EC
493
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| Mrs. Greta Beach
|
| Vol #:
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| 7
|
| |
|
|
| EC
494
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| Mrs. Donna Jason
|
| Vol #:
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| 7
|
| |
|
|
| EC
495
|
| Mr. David Ganim
|
| Vol #:
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| 7
|
| |
|
|
| EC
496
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| Mrs. Joyce Greenberg
|
| Vol #:
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| 7
|
| |
|
|
| EC
497
|
| Mrs. Amanda Moyers
|
| Vol #:
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| 7
|
| |
|
|
| EC
498
|
| Mr. Ken Greenberg
|
| Vol #:
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| 7
|
| |
|
|
| EC
499
|
| Dr. Larry Hanus
|
| Vol #:
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| 7
|
| |
|
|
| EC
500
|
| Mr. Verne Harnish
|
| Vol #:
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| 7
|
| |
|
|
| EC
501
|
| Dr. Alonzo McLeod
|
| Vol #:
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| 7
|
| |
|
|
| EC
502
|
| Mrs. Lynn McCloskey
|
| Vol #:
|
| 7
|
| |
|
|
| EC
503
|
| Mr. Michael Horton
|
| Vol #:
|
| 7
|
| |
|
|
| EC
504
|
| Katy isd
|
| Vol #:
|
| 7
|
| |
|
|
| EC
505
|
| Ms. Nancy Rinaldi
|
| Vol #:
|
| 7
|
|
| | | | | | | |
|
| |
|
| EC
506
|
| Mr. Andrew Wolf
|
| Vol #:
|
| 7
|
| |
|
|
| EC
507
|
| Mrs. michelle barton
|
| Vol #:
|
| 7
|
| |
|
|
| EC
508
|
| Mr. Henry Sonner-Bidwell
|
| Vol #:
|
| 7
|
| |
|
|
| EC
509
|
| Mrs. Gabrielle Tarr
|
| Vol #:
|
| 7
|
| |
|
|
| EC
510
|
| self
|
| Vol #:
|
| 7
|
| |
|
|
| EC
511
|
| Ms. Ulrike Gross
|
| Vol #:
|
| 7
|
| |
|
|
| EC
512
|
| Dr. Rachel Dale
|
| Vol #:
|
| 7
|
| |
|
|
| EC
513
|
| Mrs. Sarah McDowell
|
| Vol #:
|
| 7
|
| |
|
|
| EC
514
|
| Ms. Linda McCombs
|
| Vol #:
|
| 7
|
| |
|
|
| EC
515
|
| Mrs. Olga Grassi
|
| Vol #:
|
| 7
|
| |
|
|
| EC
516
|
| Mrs. Kathy Gorgey
|
| Vol #:
|
| 7
|
| |
|
|
| EC
517
|
| Heart On productions
|
| Vol #:
|
| 7
|
| |
|
|
| EC
518
|
| Mrs. Beth Dorman
|
| Vol #:
|
| 7
|
| |
|
|
| EC
519
|
| Mrs. Terre Helffrich
|
| Vol #:
|
| 7
|
| |
|
|
| EC
520
|
| Ms. Marcia Jeffers
|
| Vol #:
|
| 7
|
| |
|
|
| EC
521
|
| justforus@earthlink.net
|
| Vol #:
|
| 7
|
| |
|
|
| EC
522
|
| Kohll's Pharmacy
|
| Vol #:
|
| 7
|
| |
|
|
| EC
523
|
| Mr. Stephen Gorgey
|
| Vol #:
|
| 7
|
| |
|
|
| EC
524
|
| Ms. Margaret Dascher
|
| Vol #:
|
| 7
|
| |
|
|
| EC
525
|
| Mrs. Roxanne Stockslager
|
| Vol #:
|
| 7
|
| |
|
|
| EC
526
|
| Mrs. Diane Kerlin
|
| Vol #:
|
| 7
|
| |
|
|
| EC
527
|
| Mrs. susan mintz
|
| Vol #:
|
| 7
|
| |
|
|
| EC
528
|
| Ms. georganna cook
|
| Vol #:
|
| 7
|
| |
|
|
| EC
529
|
| Harmony Health and Wellness
|
| Vol #:
|
| 7
|
| |
|
|
| EC
530
|
| Mrs. Jan Long
|
| Vol #:
|
| 7
|
| |
|
|
| EC
531
|
| Ms. Judy M. Olsen
|
| Vol #:
|
| 7
|
| |
|
|
| EC
532
|
| Hotze Health
|
| Vol #:
|
| 7
|
| |
|
|
| EC
533
|
| Miss. Laird Roach
|
| Vol #:
|
| 7
|
| |
|
|
| EC
534
|
| Individual Consumer
|
| Vol #:
|
| 7
|
| |
|
|
| EC
535
|
| Mrs. jessica herrera
|
| Vol #:
|
| 7
|
| |
|
|
| EC
536
|
| Mr. Jim Meyers
|
| Vol #:
|
| 7
|
| |
|
|
| EC
537
|
| Mr. don fleming
|
| Vol #:
|
| 7
|
| |
|
|
| EC
538
|
| Ms. Marsha McClanahan
|
| Vol #:
|
| 7
|
| |
|
|
| EC
539
|
| Mr. Will Shepard
|
| Vol #:
|
| 7
|
| |
|
|
| EC
540
|
| Boulder Valley Women's Health Center
|
| Vol #:
|
| 7
|
| |
|
|
| EC
541
|
| Dr. Terry Bysom
|
| Vol #:
|
| 7
|
| |
|
|
| EC
542
|
| Mrs. Cathy Barnett
|
| Vol #:
|
| 7
|
|
| | | | | | | | |
|
| |
|
| EC
543
|
| Mrs. vanessa williams
|
| Vol #:
|
| 7
|
| |
|
|
| EC
544
|
| Ms. Elizabeth Radelet
|
| Vol #:
|
| 7
|
| |
|
|
| EC
545
|
| Govind S. Gill, MD
|
| Vol #:
|
| 7
|
| |
|
|
| EC
546
|
| Ms. Merylee Appel
|
| Vol #:
|
| 7
|
| |
|
|
| EC
547
|
| Ms. Patricia Wheeler
|
| Vol #:
|
| 7
|
| |
|
|
| EC
548
|
| Ms. Lee Sullivan
|
| Vol #:
|
| 7
|
| |
|
|
| EC
549
|
| Mrs. Rebecca Bacsik
|
| Vol #:
|
| 7
|
| |
|
|
| EC
550
|
| Integrated Counseling Associates
|
| Vol #:
|
| 7
|
| |
|
|
| EC
551
|
| Mr. Ken Hughes
|
| Vol #:
|
| 7
|
| |
|
|
| EC
552
|
| Mrs. Judy Rowell
|
| Vol #:
|
| 7
|
| |
|
|
| EC
553
|
| Mrs. Suzette Carter
|
| Vol #:
|
| 7
|
| |
|
|
| EC
554
|
| Mrs. Debbie Bruce
|
| Vol #:
|
| 7
|
| |
|
|
| EC
555
|
| Mrs. Nancy Hodges
|
| Vol #:
|
| 7
|
| |
|
|
| EC
556
|
| Mrs. DeAnne Gabel
|
| Vol #:
|
| 7
|
| |
|
|
| 2005P-0433
|
| Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
|
| |
|
|
| SUP
1
|
| Natural Solutions Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| SUP
2
|
| Natural Solutions Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0452
|
| FDA's decisions concerning approvals of generic versions of atorvastatin
|
| |
|
|
| EC
1
|
| Ms. David Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0487
|
| Require manufacturers to stop using xylene, toluene, and dibutyl phthalate in nail polish marketed for children under the age of 14.
|
| |
|
|
| EC
1
|
| Mr. DAVID HALPERN
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0496
|
| ANDA Suitability for Irinotecan Hydrochloride Injection, 20 mg/mL
|
| |
|
|
| EC
1
|
| Mr. Dave Lowe
|
| Vol #:
|
| 2
|
| |
|
|
| 2005P-0498
|
| Criteria of generic version of Wellbutrin XL (bupropion hydrochloride extended-release tablets)
|
| |
|
|
| EC
1
Attachment
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| EC
2
Attachment
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| EC
3
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0001
|
| Date of Approval for Lunesta (Eszopiclone) Tablets
|
| |
|
|
| EC
1
Attachment
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| EC
2
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| EC
3
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| EC
4
Attachment
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| EC
5
|
| Mr. Gregory Osment
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
| 2006P-0002
|
| Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)
|
| |
|
|
| EC
1
Attachment
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0007
|
| Oxycocone Hydrochloride and Acetaminophen Oral Solution, 10 mg/ 300 mg/5 mL.
|
| |
|
|
| EC
1
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0060
|
| ANADA for Unibute Granules 200 mg phenylbutazone per g of of granules instant of paste
|
| |
|
|
| ACK
1
|
| HFA-305 to Macleod Pharmaceuticals Inc.
|
| Vol #:
|
| 1
|
|
|
