Visitor Monitoring Drug History: PENTASA
 
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: PENTASA
FDA Application No: (NDA) 020049
Active Ingredient(s): MESALAMINE
Company: SHIRE
 
Label History
 
View the label approved on September 10, 1999 for PENTASA, (NDA) 020049


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/26/2007 019Labeling Revision Letter 
6/27/2006 017Labeling Revision Letter 
7/8/2004 015Control Supplement Letter 
9/3/2002 009Manufacturing Change or Addition  
10/12/2000 008Control Supplement  
8/24/2000 007Manufacturing Change or Addition  
9/10/1999 006Labeling Revision Letter
Label
Review 
8/5/1998 005Control Supplement  
3/19/1998 004Control Supplement  
2/19/1998 003Package Change  
10/29/1997 002Manufacturing Change or Addition  
3/11/1996 001Labeling Revision  
5/10/1993 000Approval Review 
 
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