Visitor Monitoring Drug History: ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
 
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Label and Approval History

Drug Name: ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
FDA Application No: (NDA) 020403
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on August 23, 2006 for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER, (NDA) 020403


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
8/22/2006 016Labeling Revision Letter
Label 
12/27/2005 014Labeling Revision Letter
Label 
11/24/2004 013Labeling Revision Letter
Label 
11/15/2000 012Control Supplement  
12/8/2000 011Labeling Revision  
12/8/2000 010Labeling Revision  
4/11/2000 009Labeling Revision  
2/17/1999 008Labeling Revision  
3/10/1999 007Labeling Revision  
10/31/1997 005Labeling Revision Review 
4/2/1997 004Labeling Revision  
3/12/1996 003Labeling Revision  
7/26/1996 002Package Change  
5/24/1996 001Labeling Revision  
1/31/1995 000Approval  
 
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