Visitor Monitoring Drug History: ZELNORM
 
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: ZELNORM
FDA Application No: (NDA) 021200
Active Ingredient(s): TEGASEROD MALEATE
Company: NOVARTIS
 
Label History
 
View the label approved on March 7, 2007 for ZELNORM, (NDA) 021200


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
3/1/2007 014Labeling Revision Letter
Label 
6/2/2006 012Manufacturing Change or Addition Letter 
5/25/2005 010Manufacturing Change or Addition Letter 
4/15/2004 009Labeling Revision Letter
Label 
4/21/2004 008Formulation Revision Letter
Label 
4/21/2004 007Package Change Letter
Label 
6/15/2004 006Manufacturing Change or Addition Letter
Label 
8/21/2004 005New or Modified Indication Letter
Label 
7/24/2002 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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