Visitor Monitoring Drug History: LOTENSIN
 
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Label and Approval History

Drug Name: LOTENSIN
FDA Application No: (NDA) 019851
Active Ingredient(s): BENAZEPRIL HYDROCHLORIDE
Company: NOVARTIS
 
Label History
 
View the label approved on April 5, 2004 for LOTENSIN, (NDA) 019851


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
2/2/2007 034Labeling Revision Letter 
10/29/2003 029Labeling Revision Letter 
3/2/2004 028Patient Population Altered Letter
Label 
10/25/2002 026Control Supplement  
9/20/2002 025Manufacturing Change or Addition  
4/29/2002 024Manufacturing Change or Addition  
11/30/2001 023Control Supplement  
8/13/2001 022Package Change  
12/14/2001 021Labeling Revision  
11/2/2000 020Manufacturing Change or Addition  
5/10/2000 019Manufacturing Change or Addition  
4/28/1999 018Package Change  
7/20/1998 017Control Supplement  
7/29/1998 016Labeling Revision  
8/13/1997 015Package Change  
4/18/1997 014Package Change  
1/13/1997 013Expiration Date Change  
6/25/1996 012Package Change  
11/2/1995 011Manufacturing Change or Addition  
7/7/1995 010Control Supplement  
11/22/1995 009Labeling Revision  
2/8/1995 008Control Supplement  
5/5/1995 007Labeling Revision  
3/15/1994 006Control Supplement  
10/21/1993 005Labeling Revision  
11/20/1992 004Labeling Revision  
6/25/1992 003Labeling Revision  
3/13/1992 002Package Change  
1/9/1992 001Labeling Revision  
6/25/1991 000Approval Other Important Information from FDA 
 
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