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2006P-0371: Immediately Add a Black Box Warning Regarding the Risks of Tendinopathy and Tendon Rupture to the Product Labels of all Fluoroquinolone Antibiotics Presently on the Market in the United States

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 08/29/2006 09/08/2006 Consumer Group Public Citizen's Health Research Group       pdf  
Signature: Jay Parkinson, MD, MPH and Sidney
ACK1 09/08/2006 09/08/2006 Federal Government FDA/DDM to Public Citizen's Health Research Group       pdf  
Signature: Lyle D. Jaffe
EC1 10/10/2006 10/08/2006 Individual Consumer Mr. Dave Lowe       htm
Attachment
 

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