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| Dockets Entered
On August 12, 2005
Table of Contents
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| Docket #
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| Title
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| 2002P-0120
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| Request the immediate ban of Meridia (sibutramine)
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| 2003P-0464
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| ANDA for Clonazepam Oral Solution
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005P-0072
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| Withholding of safety information regarding risks of Steven s Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Ibuprofen products
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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| 2002P-0120
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| Request the immediate ban of Meridia (sibutramine)
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| PDN
1
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| HFD-001 to Public Citzen Health Research Group
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| 1
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| 2003P-0464
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| ANDA for Clonazepam Oral Solution
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| AMD
3
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| Lachman Consultant Services, Inc.
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| 1
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS 12
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| HFA-305
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| 2
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| OR 11
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| HF-3
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| 2
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| 2004P-0520
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| 180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Inhalation solution
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| RC
3
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| IVAX Pharmaceuticals, Inc.
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| 2
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| 2005D-0062
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| Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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| C
17
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| Bristol-Myers Squibb (BMS)
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| 2
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| MO 1
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| TMJ Implants, Inc.
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| 1
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| 2005P-0072
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| Withholding of safety information regarding risks of Steven s Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Ibuprofen products
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| LET
1
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| HFD-005 to New York Medical College, et al
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| 1
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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| ACK 1
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| HFA-305 to David S. Lowe
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| 1
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| CP 1
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| David S. Lowe
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| 1
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