Visitor Monitoring Drug History: PRILOSEC
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9
Label and Approval History

Drug Name: PRILOSEC
FDA Application No: (NDA) 019810
Active Ingredient(s): OMEPRAZOLE
Company: ASTRAZENECA
 
Label History
 
View the label approved on May 1, 2007 for PRILOSEC, (NDA) 019810


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
4/27/2007 085Labeling Revision Letter
Label 
9/25/2006 084Labeling Revision Letter
Label 
1/26/2006 083Labeling Revision Letter
Label 
3/7/2005 082Labeling Revision Letter
Label 
10/9/2003 080Labeling Revision Letter
Label 
12/19/2002 077Control Supplement  
12/16/2002 076Labeling Revision Letter 
5/10/2001 075Package Change  
7/12/2002 074Patient Population Altered Letter
Label 
10/30/2001 073Labeling Revision  
8/10/2000 072Control Supplement  
2/4/2002 071Package Change  
7/27/2000 070Expiration Date Change  
7/27/2000 069Control Supplement  
3/13/2000 068Control Supplement  
10/9/2003 067Labeling Revision Letter
Label 
5/16/2001 066Package Change  
11/10/1999 065Manufacturing Change or Addition  
3/16/2000 064Manufacturing Change or Addition  
8/8/2000 063Manufacturing Change or Addition  
2/23/2000 062Labeling Revision Review 
2/14/2002 061Efficacy Supplement with Clinical Data to Support Letter 
5/18/1999 060Control Supplement  
3/13/2000 059Expiration Date Change  
2/23/2004 058Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
2/3/1999 057Labeling Revision Review 
7/10/1998 056Package Change Review 
6/30/1998 055Efficacy Supplement with Clinical Data to Support  
12/1/1998 054Control Supplement  
8/17/1998 053Package Change  
7/30/1998 052Manufacturing Change or Addition  
6/17/1997 051Control Supplement  
1/7/1998 050Package Change Review 
9/3/1997 049Manufacturing Change or Addition  
4/15/1997 048Labeling Revision  
2/18/1999 045Control Supplement  
4/4/1997 043Manufacturing Change or Addition  
4/18/1997 042Manufacturing Change or Addition  
8/9/1996 041Labeling Revision  
9/11/1996 039Control Supplement  
1/15/1998 038Formulation Revision Review 
4/15/1996 037New or Modified Indication  
11/26/1996 036New or Modified Indication Review 
3/9/1995 035Labeling Revision  
11/9/1995 034Manufacturing Change or Addition  
3/22/1996 033New or Modified Indication  
3/23/1995 032Control Supplement  
3/23/1995 031Manufacturing Change or Addition  
1/31/1995 030Manufacturing Change or Addition  
1/27/1995 029Control Supplement  
1/20/1995 028Formulation Revision  
12/29/1994 026Package Change  
10/19/1995 025Package Change  
6/16/1995 024Labeling Revision  
10/5/1995 023Formulation Revision  
3/9/1995 022Labeling Revision  
12/22/1993 021Package Change  
10/13/1994 020Manufacturing Change or Addition  
6/22/1995 019New or Modified Indication  
11/4/1997 018Labeling Revision  
6/29/1993 016Package Change  
6/15/1993 015Manufacturing Change or Addition  
10/21/1992 014Package Change  
3/19/1993 013Control Supplement  
5/26/1993 012Manufacturing Change or Addition  
3/9/1995 010Labeling Revision  
3/9/1995 009Labeling Revision  
1/27/1992 008Manufacturing Change or Addition Review 
1/3/1991 007Labeling Revision  
7/19/1990 006Labeling Revision  
9/14/1992 005Manufacturing Change or Addition  
2/23/2004 003Labeling Revision Letter
Label
Review 
6/12/1991 002New or Modified Indication  
10/26/1989 001Labeling Revision  
9/14/1989 000Approval  
 
Therapeutic Equivalents
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