Visitor Monitoring Drug History: PRELONE
 
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Label and Approval History

Drug Name: PRELONE
FDA Application No: (ANDA) 089081
Active Ingredient(s): PREDNISOLONE
Company: TEVA
 
Label History
 
Labels are not available on this site for PRELONE, (ANDA) 089081
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/9/2002 023Facility Addition  
9/11/2002 022Labeling  
9/11/2002 021Labeling  
8/5/1998 020Labeling  
6/29/1998 019Chemistry  
5/15/1998 018Labeling  
7/28/1997 017Chemistry  
5/10/1994 016Chemistry  
5/12/1994 015Labeling  
10/15/1993 014Chemistry in Effect  
7/6/1992 013Labeling in Effect  
9/3/1992 012Chemistry  
9/3/1992 011Chemistry  
9/3/1992 010Labeling  
5/10/1991 009Chemistry  
1/28/1988 008Chemistry  
1/28/1988 007Chemistry  
1/28/1988 006Chemistry  
3/24/1987 005Chemistry  
3/24/1987 004Chemistry  
5/15/1986 003Chemistry  
2/4/1986 000Approval Review 
 
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