Visitor Monitoring Drug History: FLOXIN OTIC
 
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: FLOXIN OTIC
FDA Application No: (NDA) 020799
Active Ingredient(s): OFLOXACIN
Company: DAIICHI
 
Label History
 
View the label approved on October 10, 2003 for FLOXIN OTIC, (NDA) 020799


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
5/4/2005 016Labeling Revision Letter 
2/24/2004 015Labeling Revision Letter 
10/7/2003 012Labeling Revision Letter
Label 
1/3/2003 009Control Supplement  
5/7/2002 007Manufacturing Change or Addition  
9/30/2003 006New Dosage Regimen Letter
Label 
3/16/2000 005Control Supplement  
12/22/1999 004Package Change  
8/30/1999 003Control Supplement  
2/11/1999 002Control Supplement  
3/16/1999 001Manufacturing Change or Addition  
12/16/1997 000Approval Review 
 
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