Visitor Monitoring Drug History: TEQUIN
 
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Label and Approval History

Drug Name: TEQUIN
FDA Application No: (NDA) 021062
Active Ingredient(s): GATIFLOXACIN
Company: BRISTOL MYERS SQUIBB
 
Label History
 
View the label approved on April 27, 2005 for TEQUIN, (NDA) 021062


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
3/29/2006 031Labeling Revision Letter 
12/9/2005 030Labeling Revision Letter 
9/14/2004 027Labeling Revision Letter
Label 
9/14/2004 026Labeling Revision Letter
Label 
6/30/2004 023New or Modified Indication Letter
Label 
1/6/2004 022Labeling Revision Letter
Label 
1/6/2004 021Labeling Revision Letter
Label 
12/12/2002 019Manufacturing Change or Addition  
10/23/2002 018Manufacturing Change or Addition  
10/17/2002 017Labeling Revision Letter
Label
Review 
4/17/2002 016Manufacturing Change or Addition  
12/19/2002 015Labeling Revision Letter
Label 
4/22/2002 014Manufacturing Change or Addition  
1/3/2002 013Manufacturing Change or Addition  
10/31/2001 012Labeling Revision Label 
10/17/2002 011Labeling Revision Letter
Label
Review 
10/31/2001 010Labeling Revision Label 
10/31/2001 009Labeling Revision Label 
10/12/2001 008New Dosage Regimen Letter
Label
Review 
8/20/2001 007Labeling Revision Label 
8/20/2001 006Labeling Revision Label 
3/23/2001 005Package Change  
2/2/2001 004Control Supplement  
12/13/2000 003Manufacturing Change or Addition  
12/17/1999 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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