Visitor Monitoring Drug History: CORDARONE
 
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Label and Approval History

Drug Name: CORDARONE
FDA Application No: (NDA) 018972
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
Company: WYETH PHARMS INC
 
Label History
 
View the label approved on December 6, 2004 for CORDARONE, (NDA) 018972


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/2/2007 035Labeling Revision Letter 
3/30/2007 034Labeling Revision Letter 
8/28/2006 033Labeling Revision Letter 
9/21/2006 032Labeling Revision Letter 
8/23/2005 031Labeling Revision Letter 
12/3/2004 030Labeling Revision Letter
Label
Review 
11/1/2004 029Labeling Revision Letter 
9/2/2004 028Labeling Revision Letter 
5/21/2004 027Labeling Revision Letter 
5/6/2003 026Labeling Revision Letter 
12/18/2002 025Labeling Revision Letter 
9/20/2002 024Control Supplement  
4/30/2003 023Labeling Revision Letter 
5/21/2004 022Labeling Revision Letter 
12/18/2001 021Labeling Revision  
10/8/1999 020Labeling Revision Review 
10/8/1999 019Labeling Revision Review 
6/15/1998 018Labeling Revision Review 
1/5/1999 017Labeling Revision Letter
Review 
6/15/1998 016Labeling Revision Review 
1/5/1999 015Labeling Revision Letter
Review 
10/18/1995 014Labeling Revision Review 
4/14/1994 012Labeling Revision  
8/9/1990 011Manufacturing Change or Addition  
8/9/1990 010Labeling Revision  
2/10/1989 009Labeling Revision  
7/28/1989 008Formulation Revision  
6/29/1988 007Labeling Revision  
10/28/1987 006Manufacturing Change or Addition  
8/7/1987 005Package Change  
9/14/1988 004Labeling Revision  
5/15/1987 003Labeling Revision  
12/13/1988 002Package Change  
10/7/1986 001Labeling Revision  
12/24/1985 000Approval Review
Other Important Information from FDA 
 
Therapeutic Equivalents
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