Visitor Monitoring Drug History: BETAPACE
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: BETAPACE
FDA Application No: (NDA) 019865
Active Ingredient(s): SOTALOL HYDROCHLORIDE
Company: BAYER HLTHC
 
Label History
 
View the label approved on October 1, 2001 for BETAPACE, (NDA) 019865


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
7/26/2001 014Control Supplement  
11/22/2000 012Control Supplement  
7/7/2000 011Labeling Revision  
10/1/2001 010Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
4/9/1999 009Manufacturing Change or Addition  
8/23/1999 008Labeling Revision  
12/4/1995 006Manufacturing Change or Addition  
7/26/1995 005Labeling Revision  
4/20/1994 004Labeling Revision  
9/6/1994 003Manufacturing Change or Addition  
4/20/1994 002Manufacturing Change or Addition  
4/13/1993 001Manufacturing Change or Addition  
10/30/1992 000Approval  
 
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