Visitor Monitoring Drug History: VALCYTE
 
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Label and Approval History

Drug Name: VALCYTE
FDA Application No: (NDA) 021304
Active Ingredient(s): VALGANCICLOVIR HYDROCHLORIDE
Company: ROCHE PALO
 
Label History
 
View the label approved on February 2, 2006 for VALCYTE, (NDA) 021304


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
1/31/2006 004Labeling Revision Letter
Label 
9/12/2003 001New or Modified Indication Letter
Label 
3/29/2001 000Approval Letter
Label
Review 
 
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