Visitor Monitoring Drug History: DEMI-REGROTON
 
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Label and Approval History

Drug Name: DEMI-REGROTON
FDA Application No: (NDA) 015103
Active Ingredient(s): CHLORTHALIDONE; RESERPINE
Company: SANOFI AVENTIS US
 
Label History
 
Labels are not available on this site for DEMIREGROTON, (NDA) 015103
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/26/1988 038Labeling Revision  
9/15/1987 037Labeling Revision  
9/4/1986 036Labeling Revision  
1/8/1985 035Control Supplement  
7/18/1983 034Labeling Revision  
6/3/1983 033Control Supplement  
11/21/1977 032Formulation Revision  
9/7/1977 031Formulation Revision  
3/1/1977 029Formulation Revision  
11/12/1976 028Control Supplement  
5/3/1976 027Formulation Revision  
9/8/1976 026Manufacturing Change or Addition  
9/8/1975 025Control Supplement  
7/17/1975 024Control Supplement  
7/17/1975 023Control Supplement  
7/17/1975 022Control Supplement  
5/8/1964 000Approval  
 
There are no Therapeutic Equivalents
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