Visitor Monitoring Drug History: ZOMETA
 
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Label and Approval History

Drug Name: ZOMETA
FDA Application No: (NDA) 021386
Active Ingredient(s): ZOLEDRONIC ACID
Company: NOVARTIS
 
Label History
 
View the label approved on March 25, 2004 for ZOMETA, (NDA) 021386


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
2/27/2004 001Efficacy Supplement with Clinical Data to Support Letter
Label 
2/22/2002 000Approval Letter
Label
Review
Consumer Information Sheet 
 
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