Visitor Monitoring Drug History: TOBREX
 
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Label and Approval History

Drug Name: TOBREX
FDA Application No: (ANDA) 062535
Active Ingredient(s): TOBRAMYCIN
Company: ALCON
 
Label History
 
Labels are not available on this site for TOBREX, (ANDA) 062535
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/23/2002 021Microbiology  
10/3/2002 020Control Supplement  
10/3/2002 019Facility Addition  
4/28/2000 017Microbiology  
4/21/1999 016Chemistry  
3/23/1999 015Chemistry  
5/7/1999 014Chemistry  
12/31/1998 013Chemistry  
3/4/1999 012Microbiology  
3/19/1997 011Chemistry  
4/1/1996 009Chemistry  
10/5/1995 008Microbiology  
8/4/1995 007Chemistry  
12/6/1995 006Chemistry  
12/6/1995 005Chemistry  
7/14/1994 004Labeling  
12/4/1990 003Chemistry  
12/13/1984 000Approval  
 
Therapeutic Equivalents
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