DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
COREG
FDA Application No:
(NDA) 020297
Active Ingredient(s):
CARVEDILOL
Company:
SMITHKLINE BEECHAM
Label History
View the
label approved on February 26, 2007
for COREG, (NDA) 020297
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 Date
Supplement Number
Approval Type
Letters, Reviews, Labels, Patient Package Insert
2/23/2007
022
Patient Population Altered
Letter
Label
12/20/2006
021
Labeling Revision
Letter
9/5/2006
020
Labeling Revision
Letter
Patient Information Sheet
8/28/2006
018
Efficacy Supplement with Clinical Data to Support
Letter
Label
8/17/2005
017
Labeling Revision
Letter
4/29/2005
013
New or Modified Indication
Letter
Label
9/29/2003
011
Labeling Revision
Letter
3/27/2003
009
New or Modified Indication
Letter
Review
11/8/2002
008
Control Supplement
11/1/2001
007
New or Modified Indication
Letter
Label
Review
7/10/2001
006
Manufacturing Change or Addition
10/25/2000
005
Package Change
9/8/1999
004
Labeling Revision
Review
7/28/1998
003
Labeling Revision
5/20/1996
002
Control Supplement
5/29/1997
001
New or Modified Indication
9/14/1995
000
Approval
Therapeutic Equivalents
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