Visitor Monitoring Drug History: ROWASA
 
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: ROWASA
FDA Application No: (NDA) 019618
Active Ingredient(s): MESALAMINE
Company: ALAVEN PHARM
 
Label History
 
Labels are not available on this site for ROWASA, (NDA) 019618
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/29/2005 016Labeling Revision Letter 
7/26/2002 015Control Supplement  
10/1/2001 013Labeling Revision  
7/22/1996 011Manufacturing Change or Addition  
11/22/1993 008Labeling Revision  
2/19/1992 007Labeling Revision  
3/31/1992 006Package Change  
8/20/1991 005Control Supplement  
5/24/1989 002Labeling Revision  
11/7/1988 001Manufacturing Change or Addition  
12/24/1987 000Approval  
 
Therapeutic Equivalents
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