Visitor Monitoring Drug History: SONATA
 
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Label and Approval History

Drug Name: SONATA
FDA Application No: (NDA) 020859
Active Ingredient(s): ZALEPLON
Company: KING PHARMS
 
Label History
 
View the label approved on February 22, 2001 for SONATA, (NDA) 020859


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
5/19/2003 005Labeling Revision Letter 
5/19/2003 004Labeling Revision Letter 
5/31/2002 003Labeling Revision Letter 
5/31/2002 002Labeling Revision Letter 
2/22/2001 001Efficacy Supplement with Clinical Data to Support Letter
Label 
8/13/1999 000Approval Letter
Label
Review
Other Important Information from FDA 
 
Therapeutic Equivalents
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