Visitor Monitoring Drug History: CARDIZEM
 
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: CARDIZEM
FDA Application No: (NDA) 018602
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
Company: BIOVAIL LABS INTL
 
Label History
 
Labels are not available on this site for CARDIZEM, (NDA) 018602
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/4/2001 058Control Supplement  
6/18/1999 057Control Supplement  
3/21/2003 056Labeling Revision  
2/5/1998 055Manufacturing Change or Addition  
11/19/1997 054Control Supplement  
8/4/1997 053Control Supplement  
4/2/1996 051Labeling Revision  
4/2/1996 050Labeling Revision  
8/29/1995 049Control Supplement  
12/30/1994 048Control Supplement  
11/29/1994 047Control Supplement  
5/4/1995 046Formulation Revision  
9/21/1994 045Manufacturing Change or Addition  
12/28/1994 044Package Change  
7/7/1993 043Manufacturing Change or Addition  
2/8/1993 042Package Change  
4/13/1993 041Control Supplement  
10/12/1994 040Labeling Revision  
5/27/1992 039Control Supplement  
6/13/1991 038Labeling Revision  
3/14/1991 037Manufacturing Change or Addition  
12/18/1989 036Package Change  
11/21/1989 035Package Change  
4/12/1990 034Control Supplement  
12/14/1988 033Control Supplement  
10/13/1988 032Labeling Revision  
8/12/1988 030Package Change  
2/19/1988 029Formulation Revision  
2/19/1988 028Manufacturing Change or Addition  
11/30/1987 027Expiration Date Change  
12/7/1987 026Control Supplement  
10/29/1987 025Labeling Revision  
7/1/1993 023New or Modified Indication  
7/28/1986 022Labeling Revision  
12/8/1986 020Patient Population Altered  
6/20/1985 017Package Change  
2/4/1985 014Control Supplement  
7/28/1986 011New Dosage Regimen  
6/8/1984 010Formulation Revision  
2/28/1984 009Expiration Date Change  
6/8/1984 008Control Supplement  
9/6/1983 007Expiration Date Change  
10/6/1983 006Control Supplement  
10/6/1983 005Control Supplement  
5/27/1983 004Manufacturing Change or Addition  
5/27/1983 003Package Change  
3/11/1983 002Package Change  
3/11/1983 001Formulation Revision  
11/5/1982 000Approval  
 
Therapeutic Equivalents
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