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

Drug Name: FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
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 IN PLASTIC CONTAINER, (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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