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| Dockets Entered
On December 6, 2004
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1979P-0484
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| MEMO RE "PAPER NDA'S"
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| 1990P-0201
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| Optimum size & Style of print to be used to label OTC Drugs
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| 1993N-0195
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| Safe Processing & Importing of Fish & Fishery Products
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| 1995N-0259
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| Over the Counter Drug Labeling; Public Hearing
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| 1996N-0420
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| OTC Human Drugs; Proposed Labeling Requirements
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998N-0337
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| Over the counter human drugs labeling requirements
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| 2000N-0504
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| Egg Safety Action Plan
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| 2002N-0291
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| Proposal to Debar Baldev Raj Bhutani;Notice of Opportunity
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| 2002N-0434
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| Withdrawal of Certain Proposed rules & other propose action
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| 2003D-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| 2003N-0059
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| Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
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| 2003P-0365
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| Galderma product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922 can be formulated as a topical solution with the substitution of Hydroquinone at 4% for the 2% mequinol as an ANDA
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| 2003P-0414
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| Hydrocondone Bitartrate and Acetaminophen tablets 5 mg/300 mg as an ANDA
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0493
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| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
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| 2004D-0509
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| Guidance and Protocol for Industry and Food and Drug Administration Staff: Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association
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| 2004D-0510
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| Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and
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| 2004N-0062
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
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| 2004N-0416
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| Beverages: Bottled Water
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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| 2004P-0141
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| NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
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| 2004P-0298
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| Nutrient Content Claims for the Carbohydrate Content of Food
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| 2004P-0299
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| Nutrient Content Claims for Carbohydrates
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| 2004P-0324
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| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
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| 2004P-0339
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| Refuse to file an ANDA for the combination drug amlodipine besylate-benazepril hydrochloride (amlodipine-benazepril)
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| 2004V-0537
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| Projector for a Laser Light Show
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| 1976N-0052N
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| OTC Nasal Decongestants
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| BKG
3
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| Background Material
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| Vol #:
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| 77
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| GDL
1
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| Guidance
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| Vol #:
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| 77
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| 1979P-0484
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| MEMO RE "PAPER NDA'S"
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| ACK 3
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| HFA-305 to Alan Kaplan
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| Vol #:
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| 1
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| 1990P-0201
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| Optimum size & Style of print to be used to label OTC Drugs
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| C
83
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| Cosmetic, Toiletry, and Fragrance Assn (CFTA)
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| Vol #:
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| 8
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| 1993N-0195
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| Safe Processing & Importing of Fish & Fishery Products
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| BKG 2
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| Background Material
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| Vol #:
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| 2
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| 1995N-0259
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| Over the Counter Drug Labeling; Public Hearing
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| C
29
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| Cosmetic, Toiletry, and Fragrance Assn (CTFA)
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| Vol #:
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| 13
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| 1996N-0420
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| OTC Human Drugs; Proposed Labeling Requirements
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| C
1035
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| Cosmetic, Toiletry, and Fragrance Assn (CTFA)
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| Vol #:
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| 25
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
14941
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14942
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14943
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14944
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14945
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14946
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14947
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14948
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14949
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14950
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14951
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14952
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14953
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14954
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14955
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| Leiner Health Products
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| Vol #:
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| 132
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| LET
14956
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| Lleiner Health Products
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| Vol #:
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| 132
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| 1998N-0337
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| Over the counter human drugs labeling requirements
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| C
16
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| Cosmetic, Toiletry, and Fragrance Assn (CTFA)
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| Vol #:
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| 9
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| 2000N-0504
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| Egg Safety Action Plan
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| C 148
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| M. Mulligan
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| Vol #:
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| 10
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| C 149
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| I. Mills
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| Vol #:
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| 10
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| C 150
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| K. Green
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| Vol #:
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| 10
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| C
151
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| Monty Produce Co.
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| Vol #:
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| 10
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| C 152
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| P. Dasgupta
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| Vol #:
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| 10
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| C 153
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| T. Siegrist
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| Vol #:
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| 10
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| C
154
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| Galivants Ferry Farms Corporation
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| Vol #:
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| 10
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| C 155
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| L. Allen
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| Vol #:
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| 10
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| C
156
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| Global Poultry Marketing ServicesGilman T. Dedrick
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| Vol #:
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| 10
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| C 157
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| C. McCardell
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| Vol #:
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| 10
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| 2002N-0291
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| Proposal to Debar Baldev Raj Bhutani;Notice of Opportunity
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| ND
1
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| FDA
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| Vol #:
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| 4
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| 2002N-0434
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| Withdrawal of Certain Proposed rules & other propose action
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| NWL
1
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| FDA
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| Vol #:
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| 3
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| 2003D-0112
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| Independent Consultants for Biotechnology Clinical Trias
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| CR 1
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| M. Van Hoef, MD, Ph.D., MBA
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| Vol #:
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| 1
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| 2003N-0059
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| Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach
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| C
7
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| Pfizer, Inc.
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| Vol #:
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| 13
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| 2003P-0365
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| Galderma product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922 can be formulated as a topical solution with the substitution of Hydroquinone at 4% for the 2% mequinol as an ANDA
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| PDN
2
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| HFD-600 to Jerussi Consulting, Inc.
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| Vol #:
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| 1
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| 2003P-0414
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| Hydrocondone Bitartrate and Acetaminophen tablets 5 mg/300 mg as an ANDA
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| PAV
1
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| HFD-600 to Lachman Consultant Services, Inc
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| Vol #:
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| 1
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| C
9
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| American Assn of Homes and Services for the Aging (AAHSA)
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| Vol #:
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| 1
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| C
10
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| St. Joseph Mercy Health Center
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| Vol #:
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| 1
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| C
11
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| Beaumont Services Company, LLC
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| Vol #:
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| 1
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| 2004D-0493
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| Draft Guidance for Industry on Recommended Approaches to Integration of Genetic Toxicology Study Results
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|
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|
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| GDL
1
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| Guidelines
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004D-0509
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| Guidance and Protocol for Industry and Food and Drug Administration Staff: Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association
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|
|
|
|
|
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|
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| GDL
1
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| GUIDANCE
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004D-0510
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| Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live
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|
| | | | | | | | |
|
|
|
|
| and Perishable Fish and
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|
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|
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| GDL
1
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| GUIDANCE
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004N-0062
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004N-0416
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| Beverages: Bottled Water
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| BKG
1
References
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| Quality Standard Regulation for Arsenic in Bottled Water
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| Vol #:
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| 1
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| NPR
1
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| FDA
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| Vol #:
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| 2
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| 2004N-0516
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| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
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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-0141
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| NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons
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| LET
2
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| HFD-7 to Abbott Laboratories
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| Vol #:
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| 1
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| 2004P-0202
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| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
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| C 10
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| D. Hall
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| Vol #:
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| 1
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| 2004P-0298
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| Nutrient Content Claims for the Carbohydrate Content of Food
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| LET
1
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| Unilever United States Inc
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| Vol #:
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| 2
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| SUP
3
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| Unilever United States Inc
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| Vol #:
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| 2
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| 2004P-0299
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| Nutrient Content Claims for Carbohydrates
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| LET
1
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| Frito-Lay Inc
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| Vol #:
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| 1
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| 2004P-0324
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| ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb subject to a 30-month stay of approval
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| AMD
2
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| Dey, L.P.
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| Vol #:
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| 1
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| 2004P-0339
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| Refuse to file an ANDA for the combination drug amlodipine besylate-benazepril hydrochloride (amlodipine-benazepril)
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| C
1
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| Dr. Reddy's Laboratories (Dr. Reddy's)
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| Vol #:
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| 1
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| 2004Q-0083
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| Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer
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| ANS
1
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| HFS-830 to Fleminger, Inc
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| Vol #:
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| 8
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| LET
3
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| Fleminger, Inc
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| Vol #:
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| 8
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| LET
4
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| Fleminger, Inc
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| Vol #:
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| 8
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| 2004V-0537
|
| Projector for a Laser Light Show
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| ACK
1
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| HFA-305 to Tribal Existance Productions
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| Vol #:
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| 1
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