Visitor Monitoring Drug History: TOBREX
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: TOBREX
FDA Application No: (NDA) 050555
Active Ingredient(s): TOBRAMYCIN
Company: ALCON
 
Label History
 
View the label approved on July 21, 2004 for TOBREX, (NDA) 050555


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/15/2004 022Package Change Letter
Label 
7/15/2004 021Labeling Revision Letter
Label 
3/18/2003 019Labeling Revision Letter
Label 
3/18/2003 018Manufacturing Change or Addition Letter
Label 
3/18/2003 017Labeling Revision Letter
Label 
9/28/1999 016Package Change  
4/7/1999 015Manufacturing Change or Addition  
2/5/1999 014Manufacturing Change or Addition  
5/29/1998 013Manufacturing Change or Addition  
11/29/1996 011Control Supplement  
5/18/1994 010Labeling Revision  
2/3/1992 009Control Supplement  
9/17/1992 008Chemistry Generic  
11/25/1981 000Approval  
 
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