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Dockets Management
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| Dockets
Entered On July 29, 2003
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| Docket
#
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| Title
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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| 2002H-0443
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| Civil Money Penalty Re:
LaHaye Ctr.for Advanced Eye Care
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| 2003D-0051
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| Draft Guidance
for Industry on Pre-Approval Information for Registration of New Veterinary
Medicinal Products for Food-Producing Animals with Respect to Antimicrobial
Resistance
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| 2003D-0061
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| Comparability Protocols
Chemistry Manufacturing and controls
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| 2003D-0120
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| Multiplex Tests for Heritable
DNA Markers, Mutations & Expre
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| 2003D-0165
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| Current Good Manufacturing
Practices for Medical Gases
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| 2003D-0167
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| Draft Guidance
for Industry on Dispute Resolution Procedures for Science-based Decisions
on Products Regulated by the Center for Veterinary Medicine; Availability
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| 2003D-0228
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| Draft Guidance for Industry
on Continuous Marketing Applications: Pilot 1 b Reviewable Units for
Fast Track Products Under PDUFA
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| 2003D-0229
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| Draft Guidance
for Industry on Continuous Marketing Applications: Pilot 2 b Scientific
Feedback and Interactions During Development of Fast Track Products
Under PDUFA
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| 2003E-0147
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| Patent Extension Application
for FROVA, No. 5,464,864
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| 2003E-0153
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| Patent Extension #5,420,319
for Eloxatin (oxaliplatin)
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| 2003E-0245
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| Patent Extension for Remodulin
(Treprostinil sodium), 5,153,222
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| 2003E-0252
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| Patent Extension for A180
(danofloxacin mesylate), 4,861,779
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| 2003E-0261
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| Patent Extension for Strattera
(atomoxetine hydrochloride), 5,658,590
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| 2003N-0281
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| SARS Diagnostics: Scientific
and Regulatory Challenges Public Workshop
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| 2003N-0338
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| Secretary's Roundtable
on Obesity/Nutrition
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| 2003P-0041
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| Exemption of Section 403
for application of Name Yogurt Chee
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| 2003P-0321
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| Refrain from approving
an Abbreviated New Drug Application (ANDA's) for Riavirin
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| 2000N-1571
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| Enrofloxacin
for Poultry: Opportunity for Hearing
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| TR
14
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| Corrected May 5, 2003 Transcript
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| Vol #:
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| 386
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| 2002H-0443
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| Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care
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| LET
1
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| LaHaye Center for Advanced Eye Care of LaFayette and Leon C. Lahaye
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| Vol #:
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| 1
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| |
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| 2003D-0051
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| Draft Guidance for Industry on Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance
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| C
1
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| Animal Health Institute
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| Vol #:
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| 1
| Attachment
1
Attachment 2
Attachment 3
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| 2003D-0061
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| Comparability Protocols Chemistry Manufacturing and controls
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| C
13
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 1
| Attachment | |
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| 2003D-0118
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| Decorative Contact Lens (Import alert #86-10)
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| C 47
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| Michele Y Shape-Hinchliffe, O.D.
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| Vol #:
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| 1
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| C 48
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| Nolan Jepsen, O.D.
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| Vol #:
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| 1
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| 2003D-0120
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| Multiplex Tests for Heritable DNA Markers, Mutations & Expre
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| C
16
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| Epigenomics, Inc.
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| Vol #:
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| 1
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| 2003D-0165
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| Current Good Manufacturing Practices for Medical Gases
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| C
4
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| Complient
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| Vol #:
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| 1
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| C
5
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| SOS Technologies
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| Vol #:
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| 1
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| |
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| 2003D-0167
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| Draft Guidance for Industry on Dispute Resolution Procedures for Science-based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability
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| C
1
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| Animal Health Institute (AHI)
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| Vol #:
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| 1
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| 2003D-0228
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 1 b Reviewable Units for Fast Track Products Under PDUFA
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| C
2
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| Pfizer, Inc.
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| Vol #:
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| 1
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 b Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| C
2
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| Pfizer, Inc.
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| Vol #:
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| 1
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| 2003E-0147
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| Patent Extension Application for FROVA, No. 5,464,864
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| LET
2
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0153
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| Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
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| LET
1
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| | | | | | | | |
| |
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| 2003E-0245
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| Patent Extension for Remodulin (Treprostinil sodium), 5,153,222
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| LET
2
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0252
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| Patent Extension for A180 (danofloxacin mesylate), 4,861,779
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| LET
2
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| |
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| 2003E-0261
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| Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
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| LET
2
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| HFD-005 to US Patent and Trademark Office
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| Vol #:
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| 1
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| 2003M-0320
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| Premarket Approval, FX miniRAIL, P020037
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| AAV 1
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| X Technologies, Inc.
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| Vol #:
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| 1
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| 2003M-0332
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| P010001, Ceramic TRANSCENDB. Hip Articulation System, Premarket Approval
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| AAV 1
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| Wright Medical Technology
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| Vol #:
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| 1
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| 2003M-0333
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| STAR S4 ActiveTrakb" Excimer Laser System and WaveScan WaveFrontB. System
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| AAV 1
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| VISX, Inc.
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| Vol #:
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| 1
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| 2003M-0337
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| P000013 - Osteonics ABC System and Trident System, Premarket Approval
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| AAV 1
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| Howmedica Osteonics Corporation
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| Vol #:
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| 1
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| 2003M-0339
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| P020002 - ThinPrep Imaging System, Premarket Approval
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| AAV 1
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| Cytyc Corporation
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| Vol #:
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| 1
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| 2003N-0281
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| SARS Diagnostics: Scientific and Regulatory Challenges Public Workshop
|
|
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| TR
1
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| Transcript of the July 14, 2003 meeting
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| Vol #:
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| 2
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| TS 14
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| Experience with SARS Laboratory Diagnostics
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| Vol #:
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| 1
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| 2003N-0338
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| Secretary's Roundtable on Obesity/Nutrition
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|
|
|
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| M
1
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| Memorandum to the File regarding July 30, 2003 meeting
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| Vol #:
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| 1
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| |
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| 2003P-0041
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| Exemption of Section 403 for application of Name Yogurt Chee
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| LET
1
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| HFS-800 to Bunker Hill Cheese Co., Inc.
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| Vol #:
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| 1
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| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
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| C
1
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| Three Rivers Pharmaceuticals, LLC
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| Vol #:
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| 1
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