Visitor Monitoring Drug History: CORDARONE
 
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Label and Approval History

Drug Name: CORDARONE
FDA Application No: (NDA) 020377
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
Company: WYETH PHARMS INC
 
Label History
 
Labels are not available on this site for CORDARONE, (NDA) 020377
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/28/2006 020Labeling Revision Letter 
9/15/2005 018Labeling Revision Letter 
11/2/2004 017Labeling Revision Letter 
9/2/2004 016Labeling Revision Letter 
11/4/2004 015Labeling Revision Letter 
5/6/2003 014Labeling Revision Letter 
5/6/2003 013Labeling Revision Letter 
5/9/2003 012Labeling Revision Letter 
5/9/2003 010Labeling Revision Letter 
4/11/2002 009Manufacturing Change or Addition  
11/4/2004 008Labeling Revision Letter 
11/4/2004 007Labeling Revision Letter 
5/2/2001 006Expiration Date Change  
7/11/2001 005Labeling Revision Letter 
7/11/2001 004Labeling Revision Letter 
5/14/1998 003Manufacturing Change or Addition  
12/10/1997 002Labeling Revision Review 
10/18/1995 001Labeling Revision Review 
8/3/1995 000Approval Other Important Information from FDA 
 
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