Visitor Monitoring Drug History: SEROQUEL
 
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: SEROQUEL
FDA Application No: (NDA) 020639
Active Ingredient(s): QUETIAPINE FUMARATE
Company: ASTRAZENECA
 
Label History
 
View the label approved on October 23, 2006 for SEROQUEL, (NDA) 020639


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
7/30/2007 035Labeling Revision Letter 
10/20/2006 026New or Modified Indication Letter
Label 
9/20/2006 023Labeling Revision Letter
Label 
2/7/2006 021Manufacturing Change or Addition Letter 
7/21/2004 020Labeling Revision Letter
Label 
1/12/2004 017New or Modified Indication Letter
Label 
1/12/2004 016New or Modified Indication Letter
Label 
12/6/2002 015Manufacturing Change or Addition  
11/16/2001 013Manufacturing Change or Addition  
3/19/2001 012Package Change  
3/27/2001 011Labeling Revision Letter 
11/6/2000 010Manufacturing Change or Addition  
1/24/2001 009Manufacturing Change or Addition  
7/7/2000 008Manufacturing Change or Addition  
7/26/2000 007Manufacturing Change or Addition  
12/20/1998 003Manufacturing Change or Addition  
5/8/1998 002Manufacturing Change or Addition  
2/23/1998 001Manufacturing Change or Addition  
9/26/1997 000Approval Review
Other Important Information from FDA
Patient Information Sheet 
 
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