Visitor Monitoring Drug History: DEXTROSTAT
 
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Label and Approval History

Drug Name: DEXTROSTAT
FDA Application No: (ANDA) 084051
Active Ingredient(s): DEXTROAMPHETAMINE SULFATE
Company: SHIRE
 
Label History
 
Labels are not available on this site for DEXTROSTAT, (ANDA) 084051
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
11/20/2002 024Control Supplement  
1/17/2002 023Facility Addition  
2/28/2000 022Manufacturing Revision  
1/27/2000 021Chemistry  
10/26/1998 020Labeling  
4/15/1998 019Chemistry  
5/13/1998 018Labeling  
9/26/1997 017Chemistry  
9/26/1997 016Chemistry  
8/18/1997 015Labeling  
2/28/1997 014Chemistry  
8/18/1997 013Labeling  
1/9/1998 012Chemistry  
12/8/1995 011Chemistry  
12/8/1995 010Chemistry  
5/29/1990 009Labeling  
5/29/1975 000Approval  
 
Therapeutic Equivalents
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