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| Dockets Entered
On December 9, 2003
Table of Contents
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| Docket #
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| Title
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| 1978N-0021
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| Skin Protectant Drugs for OTC Human Use
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| 1978N-0021P
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| Skin Protectant Drug Products for OTC Human Use
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| 1978N-0064
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| OTC Antiperspirant
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| |
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| |
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| 2001P-0572
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| Petition for Regulation of Ariva Tobacco Lozenges
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| 2001P-0573
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| Petition for Regulation of S & F Nicotine Water
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0276
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| Bioterrorism Preparedness; Registration of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002N-0466
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| Safety, Clinical and Immune Response of Dryvax
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| 2002P-0075
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| Flavored Candy-like Products Containing Tobacco
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| 2002P-0166
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| Print clear, legible & intelligible product expiration date
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| 2003D-0165
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| Current Good Manufacturing Practices for Medical Gases
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| 2003N-0066
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| Inspection by Accredited Persons Under MDUFMA
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| 2003N-0496
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| Food Labeling: Health Claims; Dietary Guidance
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| 2003N-0525
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
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| 2003N-0529
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| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
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| 2003P-0266
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| Lovenos(enoxaparin sodlium),NDA 20-164(90mg/0.6ml(product number 006),was not withdrawn from sale for reasons of safety or effectiveness sponsored by Aventis Pharmaceuticalls inc.
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| 2003P-0274
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| In re Tier 1 initial Approval Program
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0398
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| (ANDA) for Oral Capsule Dosage Form Containing Hydrocodone Bitartrate 5 mg/Butalbital 50 mmg/ Cafferine 40mg/ Acetaminophen 325mg
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2003P-0551
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| Citalopram Hydrobromide Capsules
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| 2003V-0550
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| Laser Light Show
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| MM
25
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| Minutes of Meeting Held on 11/19/2003 between FDA and BayerHealthCare
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| Vol #:
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| 235
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| 1978N-0021
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| Skin Protectant Drugs for OTC Human Use
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| NFR
2
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| FDA
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| Vol #:
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| 43
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| 1978N-0021P
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| Skin Protectant Drug Products for OTC Human Use
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| NFR
2
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| FDA
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| Vol #:
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| 1
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| 1978N-0064
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| OTC Antiperspirant
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| C 53
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| HFD-560 to Ms. Pamela H. Barba
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| Vol #:
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| 51
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| LET
11856
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| Flora
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| Vol #:
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| 93
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| LET
11857
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| Flora
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| Vol #:
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| 93
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| LET
11858
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| Flora
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| Vol #:
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| 93
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| LET
11859
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 93
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| LET
11860
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 93
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| LET
11861
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| Magnus Enerprises, Inc.
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| Vol #:
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| 93
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| LET
11862
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| Lapte Enterprises, Inc.
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| Vol #:
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| 93
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| LET
11863
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| Functional Integrated Therapies, L.L.C.
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| Vol #:
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| 93
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| LET
11864
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| Solstice Medicine Company
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| Vol #:
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| 93
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| LET
11865
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| Integrative Therapeutics Inc.
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| Vol #:
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| 93
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| LET
11866
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| Integrative Therapeutics Inc.
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| Vol #:
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| 93
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| LET
11867
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| Integrative Therapeutics Inc.
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| Vol #:
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| 93
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| LET
11868
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| Integrative Therapeutics Inc.
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| Vol #:
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| 93
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| LET
11869
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 93
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| |
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| LET
11870
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| LET
11871
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| LET
11872
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| LET
11873
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| LET
11874
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| Market America, Inc.
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| Vol #:
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| 93
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| LET
11875
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| Integrative Therapeutics Inc.
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| Vol #:
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| 93
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| LET
11876
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| Integrative Therapeutics Inc.
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| Vol #:
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| 93
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| |
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| LET
11877
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| Integrative Therapeutics Inc.
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| Vol #:
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| 93
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| LET
11878
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| Integrative Therapeutics Inc.
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| Vol #:
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| 93
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| LET
11879
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| Botanic Gardens, Inc.
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| Vol #:
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| 93
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| |
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| LET
11880
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| Botanic Gardens, Inc.
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| Vol #:
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| 93
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| LET
11881
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| Botanic Gardens, Inc.
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| Vol #:
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| 93
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| LET
11882
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| Indian Botanic Gardens, Inc.
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| Vol #:
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| 93
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| |
|
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| LET
11883
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| PhytoPharmica Natural Medicines
|
| Vol #:
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| 93
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| |
|
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| LET
11884
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 93
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| |
|
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| LET
11885
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| PhytoPharmica Natural Medicines
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| Vol #:
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| 93
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| |
|
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| LET
11886
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| |
|
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| LET
11887
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| |
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| LET
11888
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| Enzymatic Therapy Natural Medicines
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| Vol #:
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| 93
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| | | | | | | | |
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| C 7299
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| Paul McDaniel
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| Vol #:
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| 305
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| |
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| C 7300
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| Gail Douglas
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| Vol #:
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| 305
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| |
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| C 7301
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| Diane Koon
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| Vol #:
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| 305
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| |
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| C 7302
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| Sandra Goldstein
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| Vol #:
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| 305
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| C 7303
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| Anna Kot
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| Vol #:
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| 305
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| |
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| C 7304
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| Cassie Senneff
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| Vol #:
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| 305
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| EMC 4006
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| Despo Pullaro
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| Vol #:
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| 304
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| |
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| EMC 4007
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| Ashley Lubyk
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| Vol #:
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| 304
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| |
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| EMC 4008
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| Gail Douglas
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| Vol #:
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| 304
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| |
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| EMC 4009
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| Geneva Hultenius
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| Vol #:
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| 304
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| |
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| EMC 4010
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| Wendy Raffel
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| Vol #:
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| 304
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| |
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| EMC 4011
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| Angela Browne
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| Vol #:
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| 304
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| |
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| EMC 4012
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| Kelly & Ralph Hochendoner
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| Vol #:
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| 304
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| |
|
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| EMC 4013
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| No signature
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| Vol #:
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| 304
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| |
|
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| EMC 4014
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| Crystal King
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| Vol #:
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| 304
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| |
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| EMC 4015
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| No signature
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| Vol #:
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| 304
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| |
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| EMC 4016
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| Michele Pulling
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| Vol #:
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| 304
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| |
|
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| EMC 4017
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| DiSarlo
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| Vol #:
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| 304
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| |
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| EMC 4018
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| Rita C. Evans
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| Vol #:
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| 304
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| |
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| EMC 4019
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| Silvia Pacheco
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| Vol #:
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| 304
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| |
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| EMC 4020
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| John E. Kenney
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| Vol #:
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| 304
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| |
|
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| EMC 4021
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| Dara Eddy
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| Vol #:
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| 304
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| |
|
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| EMC 4022
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| Mary
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| Vol #:
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| 304
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| |
|
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| EMC 4023
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| Diane Miller
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| Vol #:
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| 304
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| |
|
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| EMC 4024
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| Deborah Beattie
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| Vol #:
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| 304
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| |
|
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| EMC 4025
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| Krista Francescut
|
| Vol #:
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| 304
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| |
|
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| EMC 4026
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| Tami
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| Vol #:
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| 304
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| |
|
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| EMC 4027
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| Andra J. Heide
|
| Vol #:
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| 304
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| |
|
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| EMC 4028
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| Elizabeth I. Benson
|
| Vol #:
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| 304
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| |
|
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| EMC 4029
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| Stephanie Rose
|
| Vol #:
|
| 304
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| |
|
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| EMC 4030
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| Fleurette Hamilton
|
| Vol #:
|
| 304
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| |
|
|
| EMC 4031
|
| Leland Stoelwinder
|
| Vol #:
|
| 304
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| C
293
|
| Program for Appropriate Technology in Health (PATH)
|
| Vol #:
|
| 39
|
| |
|
|
| C
294
Attachment
|
| The Alan Guttmacher Institute
|
| Vol #:
|
| 39
|
|
| | | | | | | |
| |
|
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| C
295
|
| US Conference of Catholic Bishops
|
| Vol #:
|
| 39
|
| |
|
|
| C 296
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| M.E. Smitham
|
| Vol #:
|
| 39
|
| |
|
|
| C
297
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| Gainesville (Florida) Women's Liberation
|
| Vol #:
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| 39
|
| |
|
|
| C
298
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| American College Health Assn (ACHA)
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| Vol #:
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| 39
|
| |
|
|
| C
299
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| American Society for Reproductive Medicine
|
| Vol #:
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| 39
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| |
|
|
| C
300
|
| Family Planning Advocates of NYS et al.
|
| Vol #:
|
| 39
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| |
|
|
| C
301
Attachments
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| Gainesville Area National Organization for Women et al.
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| Vol #:
|
| 39
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| |
|
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| C
302
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| Form Letters
|
| Vol #:
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| 119
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| |
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| EC 6
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| Matrisciano, Richard
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| Vol #:
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| 39
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| |
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| EC 7
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| Ramirez, Maria
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| Vol #:
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| 39
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| |
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| EC 8
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| DETAR, Julie
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| Vol #:
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| 39
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| |
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| EC 9
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| Burrhus-Clay, Anette
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| Vol #:
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| 39
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| |
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| EC 10
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| Uttley, Lois
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| Vol #:
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| 39
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| |
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| EC 11
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| Dallinga, Bree
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| Vol #:
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| 39
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| |
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| EC 12
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| Schedler, Sara
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| Vol #:
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| 39
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| |
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| EC 13
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| Anderson, Keith
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| Vol #:
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| 39
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| |
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| EC 14
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| Heitman, Timothy
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| Vol #:
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| 39
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| |
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| EC 15
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| Bergland, Rev. Craig
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| Vol #:
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| 39
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| |
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| EC 16
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| Kasprowicz, Alfred
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| Vol #:
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| 39
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| |
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| EC 17
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| Irish, Robin
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| Vol #:
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| 39
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| |
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| EC 18
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| McDermott, Daniel
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| Vol #:
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| 39
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| |
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| EC 20
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| Jones, Timothy
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| Vol #:
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| 39
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| |
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| EC 21
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| Harrison, Patty
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| Vol #:
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| 39
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| |
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| EC 22
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| Spiegel-Ootie, L
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| Vol #:
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| 39
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| |
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| EC 23
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| McIntosh, Jennifer
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| Vol #:
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| 39
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| |
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| EC 24
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| Panich, Ronald
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| Vol #:
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| 39
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| |
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| EC 25
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| Johnson, Sandi
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| Vol #:
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| 39
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| |
|
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| EC 26
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| Lopez, Destiny
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| Vol #:
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| 39
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| |
|
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| EC 27
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| Rest, Neil
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| Vol #:
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| 39
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| |
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| EC 28
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| Clardie, Serena
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| Vol #:
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| 39
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| |
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| EC 29
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| Wheat, Sarah
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| Vol #:
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| 39
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| |
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| EC 30
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| Wysocki, Susan
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| Vol #:
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| 39
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| |
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| EC 31
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| Laffin CNM, MaryAnne
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| Vol #:
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| 39
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| |
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| EC 33
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| Cole, Marian
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| Vol #:
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| 39
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| |
|
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| EC 34
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| Singer, Emily
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| Vol #:
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| 39
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| |
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| EC 35
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| Kaighin-Shields, Rachael
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| Vol #:
|
| 39
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| |
|
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| EC 36
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| Moosnick, Marcia
|
| Vol #:
|
| 39
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|
| | | | | | | | |
| |
|
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| EC 37
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| Lawrence, Rebecca
|
| Vol #:
|
| 39
|
| |
|
|
| EC 38
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| Boocock, Paul
|
| Vol #:
|
| 39
|
| |
|
|
| EC 39
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| Shipley, Alison
|
| Vol #:
|
| 39
|
| |
|
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| EC 40
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| Hatz, Madeleine
|
| Vol #:
|
| 39
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| |
|
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| EC 41
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| Armstrong, Elizabeth
|
| Vol #:
|
| 39
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| |
|
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| EC 42
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| Fell, James
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| Vol #:
|
| 39
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| |
|
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| EC 43
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| Polaneczky, Margaret
|
| Vol #:
|
| 39
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| |
|
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| EC 44
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| Hevesi, Alan G.
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| Vol #:
|
| 39
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| |
|
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| EC 45
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| Rand, Abby
|
| Vol #:
|
| 39
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| |
|
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| EC 46
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| Signer, Marjorie
|
| Vol #:
|
| 39
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| |
|
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| EC 47
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| Mair, Nadja
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| Vol #:
|
| 39
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| |
|
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| EC 48
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| tateossian, marion
|
| Vol #:
|
| 39
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| |
|
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| EC 49
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| davis, jessica
|
| Vol #:
|
| 39
|
| |
|
|
| EC 50
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| Carr, Vanessa
|
| Vol #:
|
| 39
|
| |
|
|
| EC 51
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| DiLieto, Patricia
|
| Vol #:
|
| 39
|
| |
|
|
| EC 52
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| Schick, Nance
|
| Vol #:
|
| 39
|
| |
|
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| EC 53
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| Trumps, Jeff
|
| Vol #:
|
| 39
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| |
|
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| EC 54
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| Grussgott, Jordana
|
| Vol #:
|
| 39
|
| |
|
|
| EC 55
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| Sonalkar, Sarita
|
| Vol #:
|
| 39
|
| |
|
|
| EC 56
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| Kane, Leah
|
| Vol #:
|
| 39
|
| |
|
|
| EC 57
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| Compton, Caryn
|
| Vol #:
|
| 39
|
| |
|
|
| EC 58
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| Sabatini, Sandra
|
| Vol #:
|
| 39
|
| |
|
|
| EC 59
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| Moloney, Sheila
|
| Vol #:
|
| 39
|
| |
|
|
| EC 60
|
| Mendoza, Sandy
|
| Vol #:
|
| 39
|
| |
|
|
| 2001P-0572
|
| Petition for Regulation of Ariva Tobacco Lozenges
|
| |
|
|
| C
11
|
| Homoeopathic Pharmacopoeia Convention of the United States
|
| Vol #:
|
| 3
|
| |
|
|
| 2001P-0573
|
| Petition for Regulation of S & F Nicotine Water
|
| |
|
|
| C
4
|
| Homoeopathic Pharmacopoeia Convention of the United States
|
| Vol #:
|
| 1
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 137
|
| Kathleen Robertson
|
| Vol #:
|
| 3
|
| |
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
| |
|
|
| C
170
|
| National Restaurant Assn
|
| Vol #:
|
| 15
|
| |
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
| |
|
|
| C
237
|
| National Restaurant Assn
|
| Vol #:
|
| 17
|
|
| | | | | | | | |
|
| |
|
| C
238
Attachment
|
| International Federation of Essential Oils and Aroma Trades (IFEAT)
|
| Vol #:
|
| 17
|
| |
|
|
| 2002N-0466
|
| Safety, Clinical and Immune Response of Dryvax
|
| |
|
|
| EMC 254
|
| A Trahan
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 255
|
| R Koester
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 256
|
| C Koester
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 257
|
| jim
|
| Vol #:
|
| 5
|
| |
|
|
| 2002P-0075
|
| Flavored Candy-like Products Containing Tobacco
|
| |
|
|
| C
11
|
| Homoeopathic Pharmacopoeia Convention of the United States
|
| Vol #:
|
| 3
|
| |
|
|
| 2002P-0166
|
| Print clear, legible & intelligible product expiration date
|
| |
|
|
| C 2
|
| Kenneth R. Emmel
|
| Vol #:
|
| 1
|
| |
|
|
| 2003D-0165
|
| Current Good Manufacturing Practices for Medical Gases
|
| |
|
|
| C
41
|
| U O Equipment Company (UOE)
|
| Vol #:
|
| 3
|
| |
|
|
| 2003N-0066
|
| Inspection by Accredited Persons Under MDUFMA
|
| |
|
|
| N
3
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| SS
2
|
| Supporting Statement
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0496
|
| Food Labeling: Health Claims; Dietary Guidance
|
| |
|
|
| EMC
1
|
| Georgetown University Law Center
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0525
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Jui
|
|
|
|
|
|
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0529
|
| Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0266
|
| Lovenos(enoxaparin sodlium),NDA 20-164(90mg/0.6ml(product number 006),was not withdrawn from sale for reasons of safety or effectiveness sponsored by Aventis Pharmaceuticalls inc.
|
|
|
|
|
|
|
| |
|
|
| LET
1
|
| HFD-5 to Olsson, Frank and Weeda
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0274
|
| In re Tier 1 initial Approval Program
|
| |
|
|
| C
11
|
| American Society of Clinical Oncology et al.
|
| Vol #:
|
| 1
|
| |
|
|
| C 12
|
| Kevin J. Pyle, PhD
|
| Vol #:
|
| 1
|
| |
|
|
| C 13
|
| Don N. Caswell
|
| Vol #:
|
| 1
|
| |
|
|
| C 14
|
| Afton D. Steele
|
| Vol #:
|
| 1
|
| |
|
|
| C 15
|
| Sue Schaefer
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| C 16
|
| Cheryl L. Sayre
|
| Vol #:
|
| 1
|
| |
|
|
| C
17
|
| Form Letters
|
| Vol #:
|
| 2
|
| |
|
|
| C
18
|
| Form Letters
|
| Vol #:
|
| 3
|
| |
|
|
| RC
2
|
| Abigail Alliance
|
| Vol #:
|
| 1
|
| |
|
|
| RC
3
|
| Abigail Alliance
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0362
|
| Over-the-counter Hearing Aids
|
| |
|
|
| C 5
|
| E Devilbiss
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0398
|
| (ANDA) for Oral Capsule Dosage Form Containing Hydrocodone Bitartrate 5 mg/Butalbital 50 mmg/ Cafferine 40mg/ Acetaminophen 325mg
|
| |
|
|
| WDL
1
|
| International Regulatory Business Consultants, LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
| |
|
|
| WDL
1
|
| The Center for Food Safety & Public Citizen
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0551
|
| Citalopram Hydrobromide Capsules
|
| |
|
|
| ACK 1
|
| HFA-305 to Frommer Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
| |
|
|
| ACK 2
|
| ACK 2 NUMBER NOT USED
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Tab 1,
2, 3,
4
|
| Frommer Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2003V-0550
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| HFA-305 to Whatergy Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| VAR
1
|
| Whatergy Inc.
|
| Vol #:
|
| 1
|
|
|
