Visitor Monitoring Drug History: HEPFLUSH-10
 
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Label and Approval History

Drug Name: HEPFLUSH-10
FDA Application No: (NDA) 017651
Active Ingredient(s): HEPARIN SODIUM
Company: ABRAXIS PHARM
 
Label History
 
Labels are not available on this site for HEPFLUSH10, (NDA) 017651
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/7/2003 035Manufacturing Change or Addition  
12/13/1999 033Manufacturing Change or Addition  
12/22/1997 032Manufacturing Change or Addition  
12/22/1992 031Labeling Revision  
7/31/1992 030Labeling Revision  
7/12/1995 029Control Supplement  
7/26/1996 026Control Supplement  
8/25/1993 025Labeling Revision  
2/9/1989 023Labeling Revision  
10/19/1988 022Labeling Revision  
1/8/1985 021Manufacturing Change or Addition  
7/29/1985 020Labeling Revision  
9/19/1984 019Manufacturing Change or Addition  
10/4/1984 018Labeling Revision  
6/26/1984 016General Efficacy (MarkIV)  
12/19/1983 015General Efficacy (MarkIV)  
1/12/1983 014Manufacturing Change or Addition  
4/6/1982 013Manufacturing Change or Addition  
6/2/1981 012Control Supplement  
1/21/1980 011Distributor  
10/18/1979 010Formulation Revision  
9/18/1979 009Control Supplement  
1/25/1980 008Distributor  
5/29/1979 007Control Supplement  
1/8/1979 006Control Supplement  
10/3/1979 005Control Supplement  
1/8/1979 004Distributor  
7/13/1979 003Control Supplement  
1/8/1979 002Control Supplement  
11/15/1978 001Control Supplement  
2/10/1978 000Approval Review 
 
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