DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
TEQUIN
FDA Application No:
(NDA) 021061
Active Ingredient(s):
GATIFLOXACIN
Company:
BRISTOL MYERS SQUIBB
Label History
View the
label approved on September 15, 2004
for TEQUIN, (NDA) 021061
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
3/29/2006
027
Labeling Revision
Letter
12/9/2005
026
Labeling Revision
Letter
9/14/2004
024
Labeling Revision
Letter
Label
9/14/2004
023
Labeling Revision
Letter
Label
6/30/2004
022
New or Modified Indication
Letter
Label
1/6/2004
020
Labeling Revision
Letter
Label
1/6/2004
019
Labeling Revision
Letter
Label
12/12/2002
018
Manufacturing Change or Addition
10/23/2002
017
Manufacturing Change or Addition
10/17/2002
016
Labeling Revision
Letter
Label
Review
12/19/2002
015
Labeling Revision
Letter
Label
4/22/2002
014
Manufacturing Change or Addition
1/3/2002
013
Manufacturing Change or Addition
10/31/2001
012
Labeling Revision
Label
12/19/2002
011
Package Change
Letter
Label
10/17/2002
010
Labeling Revision
Letter
Label
Review
10/31/2001
009
Labeling Revision
Label
10/31/2001
008
Labeling Revision
Label
10/12/2001
007
New Dosage Regimen
Letter
Label
Review
8/20/2001
006
Labeling Revision
Label
8/20/2001
005
Labeling Revision
Label
12/13/2000
004
Manufacturing Change or Addition
6/20/2000
001
Package Change
12/17/1999
000
Approval
Letter
Label
Review
Other Important Information from FDA
Therapeutic Equivalents
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