Visitor Monitoring Drug History: ZOFRAN PRESERVATIVE FREE
 
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: ZOFRAN PRESERVATIVE FREE
FDA Application No: (NDA) 020007
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on August 23, 2006 for ZOFRAN PRESERVATIVE FREE, (NDA) 020007


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 039Labeling Revision Letter
Label 
12/27/2005 037Labeling Revision Label 
3/25/2005 035Patient Population Altered Letter
Label 
11/24/2004 034Labeling Revision Letter
Label 
12/8/2000 032Labeling Revision  
12/8/2000 031Labeling Revision  
4/11/2000 030Labeling Revision  
5/14/1999 029Manufacturing Change or Addition  
2/17/1999 028Labeling Revision  
3/10/1999 027Labeling Revision  
8/12/1997 024Manufacturing Change or Addition  
4/2/1997 023Labeling Revision  
10/31/1997 022New Route of Administration Review 
3/12/1996 021Labeling Revision  
5/16/1996 020New or Modified Indication  
7/29/1996 019Package Change  
2/14/1995 018Manufacturing Change or Addition  
4/27/1994 016Labeling Revision  
3/31/1994 015Manufacturing Change or Addition  
1/31/1995 014Formulation Revision  
4/28/1993 013Labeling Revision  
2/9/1993 012Control Supplement  
3/24/1993 011Control Supplement  
1/22/1993 010Control Supplement  
12/10/1993 009Formulation Revision  
2/2/1993 008Labeling Revision  
2/2/1993 007Labeling Revision  
8/18/1992 006Control Supplement  
8/13/1993 005New or Modified Indication  
2/2/1993 004Labeling Revision  
2/2/1993 003New Dosage Regimen  
2/2/1993 002Labeling Revision  
2/2/1993 001Labeling Revision  
1/4/1991 000Approval Other Important Information from FDA 
 
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