DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
HEPSERA
FDA Application No:
(NDA) 021449
Active Ingredient(s):
ADEFOVIR DIPIVOXIL
Company:
GILEAD
Label History
View the
label approved on September 21, 2006
for HEPSERA, (NDA) 021449
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
009
Labeling Revision
Letter
Label
10/18/2006
006
Efficacy Supplement with Clinical Data to Support
Letter
Label
4/28/2006
005
Efficacy Supplement with Clinical Data to Support
Letter
Label
8/19/2004
003
Efficacy Supplement with Clinical Data to Support
Letter
Label
9/20/2002
000
Approval
Letter
Label
Review
Consumer Information Sheet
There are no Therapeutic Equivalents
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