Visitor Monitoring Drug History: ACCOLATE
 
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: ACCOLATE
FDA Application No: (NDA) 020547
Active Ingredient(s): ZAFIRLUKAST
Company: ASTRAZENECA
 
Label History
 
View the label approved on June 8, 2005 for ACCOLATE, (NDA) 020547


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
6/6/2005 022Labeling Revision Letter
Label 
3/26/2004 019Labeling Revision Label 
10/31/2003 017Labeling Revision Letter 
1/8/2001 016Manufacturing Change or Addition  
9/19/2000 015Manufacturing Change or Addition  
4/27/2001 014New or Modified Indication Letter 
6/12/2000 013Labeling Revision  
11/12/1999 012Manufacturing Change or Addition  
2/7/2000 011Labeling Revision Review 
9/9/1999 010Manufacturing Change or Addition  
4/30/1999 009Manufacturing Change or Addition  
3/17/1999 008Labeling Revision Review 
9/17/1999 007New or Modified Indication Letter
Review 
8/17/1998 006Labeling Revision  
5/6/1998 005Manufacturing Change or Addition  
1/23/1998 004Labeling Revision  
5/6/1998 003Manufacturing Change or Addition  
7/10/1997 002Labeling Revision  
4/28/1997 001Labeling Revision  
9/26/1996 000Approval  
 
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