Visitor Monitoring Drug History: FAZACLO ODT
 
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Label and Approval History

Drug Name: FAZACLO ODT
FDA Application No: (NDA) 021590
Active Ingredient(s): CLOZAPINE
Company: AZUR PHARMA INTL
 
Label History
 
View the label approved on June 4, 2007 for FAZACLO ODT, (NDA) 021590


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
5/30/2007 010Manufacturing Change or Addition Letter
Label 
2/16/2006 009Labeling Revision Letter
Label 
8/12/2005 008Labeling Revision Letter
Label 
6/8/2005 007Labeling Revision Letter
Label 
8/12/2005 003Labeling Revision Letter 
8/27/2004 002Labeling Revision Letter 
6/17/2004 001Labeling Revision Letter 
2/9/2004 000Approval Letter
Label
Review 
 
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