Visitor Monitoring Drug History: FLOXIN IN DEXTROSE 5%
 
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Label and Approval History

Drug Name: FLOXIN IN DEXTROSE 5%
FDA Application No: (NDA) 020087
Active Ingredient(s): OFLOXACIN
Company: ORTHO MCNEIL PHARM
 
Label History
 
Labels are not available on this site for FLOXIN IN DEXTROSE 5, (NDA) 020087
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/8/1999 024Labeling Revision  
12/8/1999 023Labeling Revision  
3/25/1999 022Manufacturing Change or Addition  
12/8/1999 021Labeling Revision  
10/20/1998 020Control Supplement  
5/12/1998 019Manufacturing Change or Addition  
4/16/1997 018Manufacturing Change or Addition  
12/19/1996 017New or Modified Indication  
8/11/1997 016Labeling Revision  
9/11/1996 015Labeling Revision  
3/22/1994 013Control Supplement  
12/27/1993 012Control Supplement  
12/7/1993 011Expiration Date Change  
5/10/1993 002Manufacturing Change or Addition  
5/19/1992 001Package Change  
3/31/1992 000Approval  
 
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