DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
ELMIRON
FDA Application No:
(NDA) 020193
Active Ingredient(s):
PENTOSAN POLYSULFATE SODIUM
Company:
ORTHO MCNEIL PHARM
Label History
View the
label approved on September 21, 2006
for ELMIRON, (NDA) 020193
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
9/20/2006
004
Labeling Revision
Letter
Label
8/24/2004
003
Labeling Revision
Letter
Label
11/8/2001
002
Control Supplement
9/26/1996
000
Approval
There are no Therapeutic Equivalents
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