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Dockets Management
Dockets Entered On July 5, 2005
Table of Contents
Docket # Title
1978N-0064 OTC Antiperspirant
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
2004D-0333 Emergency Use Authorization of Medical Products
2004P-0068 Establish specific bioequivalence requirements for oral products contanining desmopressin
2004P-0295 To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
2004P-0297 Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
2004P-0457 Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
2005M-0270 P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05
2005P-0008 simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
2005P-0046 removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
2005P-0121 None-invasive Bone Growth Stimulator be reclassified from Class III to Class II
1978N-0064 OTC Antiperspirant
SUP 7 Numark Laboratories, Inc. Vol #: 53
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7490 T. Lee Vol #: 319
C 7491 A. Andrekos Vol #: 319
2004D-0333 Emergency Use Authorization of Medical Products
GDL 1 Guidance Vol #: 1
2004P-0068 Establish specific bioequivalence requirements for oral products contanining desmopressin
PDN 1 HFD-001 to Buchanan Ingersoll, P.C. Vol #: 1
2004P-0295 To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
LET 1 HFD-007 to Lachman Consultant Services Inc. Vol #: 1
2004P-0297 Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free
LET 3 Center for Science in the Public Interest (CSPI) Vol #: 3
2004P-0457 Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
LET 2 HFZ-400 to Endotec, Incorporated Vol #: 2
2005M-0270 P030049 - ADVIA Centaur HBsAg ReadyPack Reagents, ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, and ADVIA Centaur HBsAg Quality Control Material - Approved 5/31/05
AAV 1 Bayer HealthCare LLC Vol #: 1
2005P-0008 simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
C 4 Ranbaxy Laboratories, Inc. (Ranbaxy) Vol #: 2
LET 1 HFD-005 to Ivax Pharmaceuticals, Inc. Vol #: 2
2005P-0046 removal of patent listings by reinserting the info in the orange book and maintain the listing until Ranbaxy's term of exclusivity has elapsed
RC 1 Ranbaxy Laboratories, INc. (Ranbaxy) Vol #: 1
2005P-0121 None-invasive Bone Growth Stimulator be reclassified from Class III to Class II
C 1 H. Yuan, M.D. Vol #: 1

Page created on July 13, 2005 RSC

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