Visitor Monitoring Drug History: ROCALTROL
 
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Label and Approval History

Drug Name: ROCALTROL
FDA Application No: (NDA) 021068
Active Ingredient(s): CALCITRIOL
Company: ROCHE
 
Label History
 
View the label approved on November 20, 1998 for ROCALTROL, (NDA) 021068


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
7/7/2004 002Labeling Revision Letter 
2/1/2002 001Labeling Revision Letter 
11/20/1998 000Approval Letter
Label
Review 
 
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