Visitor Monitoring Drug History: CALDEROL
 
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Label and Approval History

Drug Name: CALDEROL
FDA Application No: (NDA) 018312
Active Ingredient(s): CALCIFEDIOL
Company: ORGANON USA INC
 
Label History
 
Labels are not available on this site for CALDEROL, (NDA) 018312
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/15/2000 012Labeling Revision  
12/9/1997 011Manufacturing Change or Addition  
2/18/1994 010Manufacturing Change or Addition  
11/30/1988 009Manufacturing Change or Addition  
6/16/1986 008Labeling Revision  
6/16/1986 007Control Supplement  
6/12/1984 004Labeling Revision  
8/5/1980 000Approval  
 
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