DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
Label and Approval History
Drug Name:
KYTRIL
FDA Application No:
(NDA) 020239
Active Ingredient(s):
GRANISETRON HYDROCHLORIDE
Company:
ROCHE
Label History
View the
label approved on November 30, 2005
for KYTRIL, (NDA) 020239
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
11/23/2005
018
Labeling Revision
Letter
Label
9/17/2004
017
Manufacturing Change or Addition
Letter
9/17/2004
016
Formulation Revision
Letter
8/20/2004
015
Formulation Revision
Letter
Label
11/25/2002
011
Control Supplement
11/5/2002
009
Manufacturing Change or Addition
8/16/2002
008
New or Modified Indication
Letter
Label
3/20/1997
007
Labeling Revision
5/30/1997
006
Formulation Revision
10/24/1996
005
Manufacturing Change or Addition
1/21/1997
004
New Dosage Regimen
11/21/1995
003
Labeling Revision
1/21/1997
002
Labeling Revision
3/11/1994
001
Formulation Revision
12/29/1993
000
Approval
There are no Therapeutic Equivalents
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