Visitor Monitoring Drug History: MIACALCIN
 
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Label and Approval History

Drug Name: MIACALCIN
FDA Application No: (NDA) 020313
Active Ingredient(s): CALCITONIN, SALMON
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for MIACALCIN, (NDA) 020313
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/22/2003 023Control Supplement Letter
Review 
1/6/2006 021Labeling Revision Letter 
5/10/2002 020Control Supplement  
11/2/2001 018Manufacturing Change or Addition  
7/14/2000 017Control Supplement  
7/23/1999 015Control Supplement  
1/13/1999 014Manufacturing Change or Addition  
12/17/1998 012Manufacturing Change or Addition  
8/14/1998 011Manufacturing Change or Addition  
1/12/1998 010Labeling Revision  
9/15/1997 008Control Supplement  
8/1/1997 007Control Supplement  
4/24/1997 006Control Supplement  
3/27/1997 005Control Supplement  
12/24/1998 004Package Change  
3/7/1997 003Labeling Revision  
10/22/1996 002Labeling Revision  
8/17/1995 000Approval  
 
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