Visitor Monitoring Drug History: ZITHROMAX
 
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: ZITHROMAX
FDA Application No: (NDA) 050710
Active Ingredient(s): AZITHROMYCIN
Company: PFIZER
 
Label History
 
View the label approved on January 22, 2004 for ZITHROMAX, (NDA) 050710


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
1/15/2004 021Labeling Revision Letter
Label 
12/18/2003 020Labeling Revision Letter 
4/27/2004 019Labeling Revision Letter 
1/15/2004 017Labeling Revision Letter
Label 
6/20/2003 016Labeling Revision Letter 
7/22/2002 014Labeling Revision Letter 
12/10/2001 012Manufacturing Change or Addition  
5/24/2002 011Labeling Revision Letter
Label
Review 
12/14/2001 009New Dosage Regimen Letter
Label 
12/14/2001 008New Dosage Regimen Letter
Label 
10/16/2002 007Labeling Revision Letter 
11/11/2000 006Labeling Revision  
11/22/1999 005Manufacturing Change or Addition  
11/8/1999 004Package Change  
3/18/1996 003Control Supplement  
3/14/1996 002Control Supplement  
12/20/1996 001Patient Population Altered  
10/19/1995 000Approval  
 
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