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| Lovenos(enoxaparin sodlium),NDA 20-164(90mg/0.6ml(product number 006),was not withdrawn from sale for reasons of safety or effectiveness sponsored by Aventis Pharmaceuticalls inc.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