Visitor Monitoring Drug History: LEUKERAN
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: LEUKERAN
FDA Application No: (NDA) 010669
Active Ingredient(s): CHLORAMBUCIL
Company: SMITHKLINE BEECHAM
 
Label History
 
View the label approved on December 2, 2003 for LEUKERAN, (NDA) 010669


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 DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/24/2005 029Labeling Revision Letter 
11/13/2003 028Labeling Revision Letter
Label 
11/14/2002 025Manufacturing Change or Addition  
6/20/2001 024Labeling Revision Letter 
7/24/2001 023Formulation Revision Letter 
7/24/2001 022Control Supplement Letter 
7/24/2001 021Manufacturing Change or Addition Letter 
6/29/1995 020Control Supplement  
2/4/1994 018Manufacturing Change or Addition  
2/9/1996 017Labeling Revision  
10/14/1992 016Control Supplement  
2/28/1989 015Labeling Revision  
3/6/1990 014Package Change  
9/22/1986 012Labeling Revision  
3/12/1984 011Practioner Draft Labeling  
8/27/1981 009Labeling Revision  
6/8/1978 008Package Change  
3/22/1978 007Control Supplement  
2/15/1979 006Control Supplement  
3/9/1977 005Control Supplement  
3/18/1957 000Approval Label 
 
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