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Dockets Management
Dockets Entered On March 24, 2005
Table of Contents
Docket # Title
1977N-0230 Penicillin-Containing Premixes
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
1990S-0308 Generic Drug Speeches & Policy and Procedure Guides
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2004D-0524 Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
2004P-0329 Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
2005P-0095 ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
2005P-0114 ANDA for Cefriaxone for injection, USP, pharmacy bulk package in a 100 gram dosage strength packaged in plastic bags that are contained within foil outer wraps
2005P-0115 Immediately remove from the market pemoline CYLER- Abbott Laboratories, and all generic versions, a stimulant drug for the treatment of attention deficit hyperactivity disorder.
1977N-0230 Penicillin-Containing Premixes
ANS 5 Joseph P, Hile to A. Karim Ahmed, Ph.D. Vol #: 24
ANS 6 Arthur Hull Hayes Jr. MD Vol #: 24
ANS 7 Phillip J. Frappaolo Vol #: 24
1980N-0208 Biological Products; Bacterial Vaccines and Toxiods
C 16 Department of the Army Vol #: 142
1990S-0308 Generic Drug Speeches & Policy and Procedure Guides
M 740 Statistical Report - Month of January 2004 Vol #: 53
M 741 Statistical Report - Month of February 2004 Vol #: 53
M 742 Statistical Report - Month of March 2004 Vol #: 53
M 743 Statistical Report - Month of April 2004 Vol #: 53
M 744 Statistical Report - Month of May 2004 Vol #: 53
M 745 Statistical Report - Month of June 2004 Vol #: 53
M 746 Statistical Report - Month of July 2004 Vol #: 53
M 747 Statistical Report - Month of August 2004 Vol #: 53
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 15698 Lyons Health Products Vol #: 138
LET 15699 Hillestad Pharmaceuticals Vol #: 138
LET 15700 Nature's Way Products, Inc. Vol #: 138
LET 15701 Hillestad Pharmaceutials Vol #: 138
LET 15702 Hillestad Pharmaceuticals Vol #: 138
LET 15703 Hillestad Pharmaceuticals Vol #: 138
LET 15704 LaneLabs USA, Inc. Vol #: 138
LET 15705 LaneLabs USA, Inc. Vol #: 138
2004D-0524 Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
C 5 GlaxoSmithKline (GSK) Vol #: 1
2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action
C 200 Pet Food Institute (PFI) Vol #: 23
2004P-0329 Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
LET 1 HFZ-001 to Russel J. Thomsen, M.D. Vol #: 1
2005P-0095 ANDA 505(b)(2) application for any generic version or other pharmaceutical alternative of Venofer(Iron sucrose injection USP
LET 1 Luitpold Pharmaceuticals, Inc., (Luitpold) Vol #: 2
2005P-0114 ANDA for Cefriaxone for injection, USP, pharmacy bulk package in a 100 gram dosage strength packaged in plastic bags that are contained within foil outer wraps
CP 1 Samson Medical Technologies, L.L.C. Vol #: 1
2005P-0115 Immediately remove from the market pemoline CYLER- Abbott Laboratories, and all generic versions, a stimulant drug for the treatment of attention deficit hyperactivity disorder.
ACK 1 HFA-305 to Public Citizen Vol #: 1
CP 1 Public Citizen Vol #: 1

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