DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
OMNICEF
FDA Application No:
(NDA) 050749
Active Ingredient(s):
CEFDINIR
Company:
ABBOTT
Label History
View the
label approved on September 19, 2007
for OMNICEF, (NDA) 050749
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
9/14/2007
018
Labeling Revision
Letter
Label
6/15/2007
017
Labeling Revision
Letter
Label
7/19/2005
013
Labeling Revision
Letter
Label
7/29/2004
010
Control Supplement
Letter
9/2/2004
009
Labeling Revision
Letter
6/18/2001
006
Manufacturing Change or Addition
7/13/1999
004
Labeling Revision
7/14/1999
002
New Dosage Regimen
Letter
Label
4/22/1998
001
Control Supplement
12/4/1997
000
Approval
Review
Therapeutic Equivalents
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