Visitor Monitoring Drug History: ORAP
 
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: ORAP
FDA Application No: (NDA) 017473
Active Ingredient(s): PIMOZIDE
Company: TEVA
 
Label History
 
Labels are not available on this site for ORAP, (NDA) 017473
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/27/2003 039Labeling Revision Letter 
11/14/2002 038Labeling Revision Letter 
11/9/1999 036Labeling Revision  
11/12/1999 035Manufacturing Change or Addition  
5/23/2000 034Control Supplement  
11/9/1999 033Labeling Revision  
5/20/1998 032Labeling Revision  
3/23/1998 031Control Supplement  
10/23/1997 030Manufacturing Change or Addition  
8/27/1997 029Manufacturing Change or Addition  
5/30/1997 027Control Supplement  
1/7/1997 026Control Supplement  
7/9/1996 024Control Supplement  
11/22/1995 023Manufacturing Change or Addition  
11/22/1995 022Manufacturing Change or Addition  
10/20/1995 021Control Supplement  
11/2/1994 020Control Supplement  
5/10/1995 019Manufacturing Change or Addition  
12/12/1994 018Control Supplement  
12/21/1990 017Manufacturing Change or Addition  
7/27/1994 016Labeling Revision  
7/27/1994 015Patient Population Altered  
2/12/1990 014Manufacturing Change or Addition  
12/16/1988 013Control Supplement  
12/21/1990 012Labeling Revision  
10/27/1988 011Labeling Revision  
11/29/1988 010Control Supplement  
10/7/1987 009Labeling Revision  
9/17/1986 008Labeling Revision  
4/20/1987 007Expiration Date Change  
8/15/1985 006Control Supplement  
3/21/1985 004Labeling Revision  
3/11/1985 002Labeling Revision  
11/14/1984 001Manufacturing Change or Addition  
7/31/1984 000Approval  
 
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