DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
EMLA
FDA Application No:
(NDA) 019941
Active Ingredient(s):
LIDOCAINE; PRILOCAINE
Company:
ABRAXIS BIOSCIENCE
Label History
View the
label approved on May 1, 2006
for EMLA, (NDA) 019941
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
4/27/2006
018
Labeling Revision
Letter
Label
12/19/2005
017
Labeling Revision
Letter
Label
1/27/2003
015
Package Change
Letter
6/2/2000
013
Control Supplement
4/20/2000
012
Labeling Revision
1/28/2000
011
New or Modified Indication
Letter
Label
Review
3/11/1999
010
Efficacy Supplement with Clinical Data to Support
Letter
2/4/1998
009
Labeling Revision
Review
2/4/1998
008
Comparative Efficacy Claim
Review
2/4/1998
007
Labeling Revision
Review
5/31/1996
006
Manufacturing Change or Addition
5/31/1996
005
Manufacturing Change or Addition
9/27/1995
003
Manufacturing Change or Addition
4/11/1994
002
Labeling Revision
12/30/1992
000
Approval
There are no Therapeutic Equivalents
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