Visitor Monitoring Drug History: FLUDARA
 
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: FLUDARA
FDA Application No: (NDA) 020038
Active Ingredient(s): FLUDARABINE PHOSPHATE
Company: BAYER HLTHC
 
Label History
 
View the label approved on August 14, 2003 for FLUDARA, (NDA) 020038


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
8/1/2003 028Efficacy Supplement with Clinical Data to Support Letter
Label 
5/1/2002 025Control Supplement  
5/1/2002 024Manufacturing Change or Addition  
3/28/2002 023Control Supplement  
7/2/2002 022Control Supplement  
7/2/2002 021Manufacturing Change or Addition  
3/8/2000 020Package Change  
12/3/2001 019Labeling Revision Label 
9/5/1996 018Control Supplement  
5/24/1999 017Labeling Revision  
1/29/1996 015Control Supplement  
9/26/1994 014Labeling Revision  
5/21/1993 013Manufacturing Change or Addition  
10/28/1992 011Labeling Revision  
1/7/1993 008Manufacturing Change or Addition  
1/7/1993 007Control Supplement  
4/2/1992 006Labeling Revision  
12/4/1991 005Control Supplement  
12/4/1991 003Control Supplement  
4/18/1991 000Approval Label 
 
Therapeutic Equivalents
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