Visitor Monitoring Drug History: BETAPACE AF
 
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Label and Approval History

Drug Name: BETAPACE AF
FDA Application No: (NDA) 021151
Active Ingredient(s): SOTALOL HYDROCHLORIDE
Company: BAYER HLTHC
 
Label History
 
View the label approved on February 22, 2000 for BETAPACE AF, (NDA) 021151


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
4/2/2003 005Control Supplement Letter 
3/14/2003 004Control Supplement Letter 
10/1/2001 003Labeling Revision  
11/22/2000 001Control Supplement  
2/22/2000 000Approval Letter
Label
Review 
 
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