Visitor Monitoring Drug History: ZINACEF IN PLASTIC CONTAINER
 
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Label and Approval History

Drug Name: ZINACEF IN PLASTIC CONTAINER
FDA Application No: (NDA) 050643
Active Ingredient(s): CEFUROXIME SODIUM
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on July 31, 2007 for ZINACEF IN PLASTIC CONTAINER, (NDA) 050643


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 021Labeling Revision Letter
Label 
5/19/2004 015Labeling Revision Letter
Label 
11/9/2001 013Control Supplement  
4/13/2001 012Control Supplement  
10/12/2001 011Labeling Revision Label 
7/12/2001 010Labeling Revision  
12/23/1996 009Labeling Revision  
9/11/1996 008Labeling Revision  
12/23/1996 007Labeling Revision  
9/29/1995 006Labeling Revision  
10/27/1994 005Labeling Revision  
2/6/1995 004Labeling Revision  
3/30/1992 003Manufacturing Change or Addition  
10/23/1995 002Labeling Revision  
1/15/1993 001Control Supplement  
4/28/1989 000Approval  
 
There are no Therapeutic Equivalents
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