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) 050541
Active Ingredient(s): TOBRAMYCIN
Company: FALCON PHARMS
 
Label History
 
View the label approved on July 28, 2003 for TOBREX, (NDA) 050541


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
12/4/2002 019Control Supplement  
5/2/2002 018Control Supplement  
7/22/2003 017Labeling Revision Letter
Label 
2/18/2000 015Manufacturing Change or Addition  
8/17/1999 014Control Supplement  
2/5/1999 013Manufacturing Change or Addition  
3/11/1999 012Control Supplement  
12/18/1998 011Manufacturing Change or Addition  
8/4/1998 010Control Supplement  
1/15/1998 009Manufacturing Change or Addition  
6/25/1996 007Manufacturing Change or Addition  
3/5/1996 006Control Supplement  
11/1/1995 005Control Supplement  
11/1/1995 004Control Supplement  
7/27/1994 003Control Supplement  
6/13/1994 002Labeling Revision  
6/13/1995 001Package Change  
12/12/1980 000Approval  
 
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