Visitor Monitoring Drug History: PROTONIX
 
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: PROTONIX
FDA Application No: (NDA) 020987
Active Ingredient(s): PANTOPRAZOLE SODIUM
Company: WYETH PHARMS INC
 
Label History
 
View the label approved on April 5, 2004 for PROTONIX, (NDA) 020987


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
7/25/2006 032Labeling Revision Letter 
11/18/2004 026Labeling Revision Letter 
3/12/2004 023Labeling Revision Letter
Label 
1/9/2004 022Labeling Revision Letter
Label 
12/30/2003 021Labeling Revision Letter 
5/5/2004 020Labeling Revision Letter
Label 
3/5/2004 017Labeling Revision Letter
Label 
12/4/2002 016Control Supplement  
12/3/2002 015Control Supplement  
12/6/2002 014Manufacturing Change or Addition  
10/28/2002 013Labeling Revision Letter 
7/22/2002 012Manufacturing Change or Addition  
9/5/2002 011Control Supplement  
5/14/2002 010Manufacturing Change or Addition  
7/2/2002 009Control Supplement  
3/12/2002 008Manufacturing Change or Addition  
4/19/2002 007New or Modified Indication Letter
Label
Review 
6/12/2002 006Manufacturing Change or Addition  
7/20/2001 005Labeling Revision Label 
5/21/2001 004Labeling Revision  
10/19/2000 003Manufacturing Change or Addition  
6/12/2001 002Formulation Revision Letter 
6/12/2001 001New or Modified Indication Letter
Label 
2/2/2000 000Approval Letter
Label
Review
Consumer Information Sheet 
 
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