Visitor Monitoring Drug History: CARDIZEM SR
 
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Label and Approval History

Drug Name: CARDIZEM SR
FDA Application No: (NDA) 019471
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
Company: BIOVAIL
 
Label History
 
Labels are not available on this site for CARDIZEM SR, (NDA) 019471
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/4/2001 031Control Supplement  
12/6/1999 030Manufacturing Change or Addition  
3/21/2003 029Labeling Revision  
12/3/1998 028Manufacturing Change or Addition  
11/20/1997 027Control Supplement  
8/5/1997 026Control Supplement  
5/16/1996 025Control Supplement  
5/28/1996 024Labeling Revision  
3/17/1995 023Control Supplement  
9/14/1994 021Package Change  
9/14/1994 020Manufacturing Change or Addition  
4/3/1995 019Package Change  
3/18/1994 018Control Supplement  
3/15/1994 017Control Supplement  
8/2/1993 016Manufacturing Change or Addition  
4/1/1993 015Labeling Revision  
10/22/1992 014Control Supplement  
10/22/1992 013Control Supplement  
6/13/1991 011Labeling Revision  
7/1/1992 010Labeling Revision  
1/7/1991 008Package Change  
9/14/1990 007Control Supplement  
5/3/1991 006Manufacturing Change or Addition  
7/27/1990 005Package Change  
8/16/1990 004Control Supplement  
4/23/1990 002Package Change  
3/8/1989 001Control Supplement  
1/23/1989 000Approval  
 
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