DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
PROZAC
FDA Application No:
(NDA) 020974
Active Ingredient(s):
FLUOXETINE HYDROCHLORIDE
Company:
LILLY
Label History
View the
label approved on September 21, 2006
for PROZAC, (NDA) 020974
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
008
Labeling Revision
Label
4/11/2006
007
Labeling Revision
Letter
2/18/2005
006
Labeling Revision
Letter
12/1/2005
005
Labeling Revision
Letter
8/19/2004
004
Labeling Revision
Letter
7/29/2002
001
Efficacy Supplement with Clinical Data to Support
3/9/1999
000
Approval
Letter
Review
Other Important Information from FDA
Therapeutic Equivalents
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