Visitor Monitoring Drug History: ORUDIS
 
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: ORUDIS
FDA Application No: (NDA) 018754
Active Ingredient(s): KETOPROFEN
Company: WYETH AYERST
 
Label History
 
Labels are not available on this site for ORUDIS, (NDA) 018754
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/18/2006 027Labeling Revision Letter 
8/18/2003 026Labeling Revision Letter 
8/5/1997 025Labeling Revision Review 
2/8/1995 024Labeling Revision  
7/11/1994 023Control Supplement  
7/11/1994 022Control Supplement  
2/17/1995 020Manufacturing Change or Addition  
1/6/1994 018New or Modified Indication  
10/26/1988 015Package Change  
10/5/1989 014Package Change  
1/16/1990 013Formulation Revision  
1/11/1989 012Manufacturing Change or Addition  
2/18/1988 011Labeling Revision  
9/5/1990 010Package Change  
10/5/1989 009Package Change  
7/23/1987 007Labeling Revision  
4/10/1989 006Manufacturing Change or Addition  
7/16/1986 005Manufacturing Change or Addition  
7/31/1987 004Labeling Revision  
7/31/1987 003New or Modified Indication  
3/17/1987 002Manufacturing Change or Addition  
1/27/1986 001Labeling Revision  
1/9/1986 000Approval  
 
Therapeutic Equivalents
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