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) 050670
Active Ingredient(s): AZITHROMYCIN
Company: PFIZER
 
Label History
 
View the label approved on April 5, 2004 for ZITHROMAX, (NDA) 050670


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 022Labeling Revision Letter 
3/24/2004 021Labeling Revision Letter
Label 
7/22/2002 019Labeling Revision Letter 
10/16/2002 017Labeling Revision Letter 
11/13/2000 015New or Modified Indication Letter
Label
Review 
11/11/2000 014Labeling Revision  
11/22/1999 013Manufacturing Change or Addition  
2/24/1999 012Control Supplement  
7/12/1996 011Manufacturing Change or Addition  
12/20/1996 010Patient Population Altered  
11/22/1996 008New or Modified Indication Review 
5/11/1994 007Manufacturing Change or Addition  
11/30/1993 006Manufacturing Change or Addition  
11/30/1993 005Manufacturing Change or Addition  
2/29/1996 003Labeling Revision  
2/11/1992 002Labeling Revision  
4/13/1992 001Package Change  
11/1/1991 000Approval  
 
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