Visitor Monitoring Drug History: ACTONEL WITH CALCIUM (COPACKAGED)
 
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Label and Approval History

Drug Name: ACTONEL WITH CALCIUM (COPACKAGED)
FDA Application No: (NDA) 021823
Active Ingredient(s): CALCIUM CARBONATE; RISEDRONATE SODIUM
Company: PROCTER AND GAMBLE
 
Label History
 
View the label approved on August 23, 2006 for ACTONEL WITH CALCIUM (COPACKAGED), (NDA) 021823


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
8/22/2006 004Labeling Revision Letter
Label 
6/19/2006 003Labeling Revision Letter 
1/24/2006 002Labeling Revision Letter
Label 
8/12/2005 000Approval Letter
Label 
 
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