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) 050739
Active Ingredient(s):
CEFDINIR
Company:
ABBOTT
Label History
View the
label approved on September 19, 2007
for OMNICEF, (NDA) 050739
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
014
Labeling Revision
Letter
Label
6/15/2007
013
Labeling Revision
Letter
Label
7/19/2005
010
Labeling Revision
Letter
Label
9/2/2004
007
Labeling Revision
Letter
7/24/2002
006
Labeling Revision
Letter
6/18/2001
005
Manufacturing Change or Addition
11/9/2000
004
Package Change
11/8/1999
002
New Dosage Regimen
Letter
Label
1/13/1998
001
Expiration Date Change
12/4/1997
000
Approval
Review
Therapeutic Equivalents
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