DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
BANAN
FDA Application No:
(NDA) 050688
Active Ingredient(s):
CEFPODOXIME PROXETIL
Company:
SANKYO
Label History
View the
label approved on February 10, 2000
for BANAN, (NDA) 050688
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
2/10/2000
013
Labeling Revision
Letter
Label
Review
2/10/2000
012
New Dosage Regimen
Letter
Label
Review
2/10/2000
011
New Dosage Regimen
Letter
Label
Review
2/10/2000
010
Labeling Revision
Letter
Label
Review
2/10/2000
009
Labeling Revision
Letter
Label
Review
2/10/2000
008
New or Modified Indication
Letter
Label
Review
5/27/1999
007
Labeling Revision
2/10/2000
006
Efficacy Supplement with Clinical Data to Support
Letter
Label
Review
5/26/1999
005
Labeling Revision
6/16/1995
004
New or Modified Indication
4/8/1993
003
Labeling Revision
10/12/1993
002
Labeling Revision
12/22/1997
001
New or Modified Indication
8/7/1992
000
Approval
There are no Therapeutic Equivalents
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