DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
CARDIZEM
FDA Application No:
(NDA) 020027
Active Ingredient(s):
DILTIAZEM HYDROCHLORIDE
Company:
BIOVAIL LABS INTL
Label History
Labels are not available on this site for CARDIZEM, (NDA) 020027
Approval History
Action Date
Supplement Number
Approval Type
Letters, Reviews, Labels, Patient Package Insert
6/4/2001
020
Control Supplement
12/21/2004
019
Labeling Revision
Letter
2/5/1998
018
Manufacturing Change or Addition
11/20/1997
017
Control Supplement
9/2/1997
016
Control Supplement
8/5/1997
015
Control Supplement
1/14/1997
014
Manufacturing Change or Addition
5/28/1996
013
Control Supplement
6/4/1996
012
Formulation Revision
4/2/1996
011
Labeling Revision
1/4/1996
010
Control Supplement
4/2/1996
009
Labeling Revision
10/24/1995
008
Control Supplement
1/12/1995
007
Control Supplement
8/18/1995
006
Formulation Revision
9/28/1994
005
Manufacturing Change or Addition
8/15/1994
004
Package Change
4/28/1993
003
Labeling Revision
5/24/1994
002
Manufacturing Change or Addition
4/1/1992
001
Labeling Revision
10/24/1991
000
Approval
Therapeutic Equivalents
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