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| Dockets Entered
On July 5, 2005
Table of Contents
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| Docket #
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| Title
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| 1978N-0064
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| OTC Antiperspirant
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| 2004P-0068
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| Establish specific bioequivalence requirements for oral products contanining desmopressin
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| 2004P-0295
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| To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
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| 2004P-0297
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| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
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| 2004P-0457
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| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
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| 2005M-0270
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| P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 2005P-0046
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| removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
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| 2005P-0121
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| None-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 1978N-0064
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| OTC Antiperspirant
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| SUP
7
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| Numark Laboratories, Inc.
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| Vol #:
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| 53
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7490
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| T. Lee
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| Vol #:
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| 319
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| C 7491
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| A. Andrekos
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| Vol #:
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| 319
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| 2004D-0333
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| Emergency Use Authorization of Medical Products
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| GDL
1
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| Guidance
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| 1
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| 2004P-0068
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| Establish specific bioequivalence requirements for oral products contanining desmopressin
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| PDN
1
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| HFD-001 to Buchanan Ingersoll, P.C.
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| 1
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| 2004P-0295
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| To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
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| LET
1
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| HFD-007 to Lachman Consultant Services Inc.
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| Vol #:
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| 1
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| 2004P-0297
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| Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
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| LET 3
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 3
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| 2004P-0457
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| Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
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| LET
2
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| HFZ-400 to Endotec, Incorporated
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| Vol #:
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| 2
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| 2005M-0270
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| P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05
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| AAV
1
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| Bayer HealthCare LLC
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| Vol #:
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| 1
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| C
4
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| Ranbaxy Laboratories, Inc. (Ranbaxy)
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| Vol #:
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| 2
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