Visitor Monitoring Drug History: GYNAZOLE-1
 
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: GYNAZOLE-1
FDA Application No: (NDA) 019881
Active Ingredient(s): BUTOCONAZOLE NITRATE
Company: KV PHARM
 
Label History
 
View the label approved on August 6, 2003 for GYNAZOLE1, (NDA) 019881


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
7/24/2003 009Labeling Revision Letter
Label 
8/2/2002 008Control Supplement  
9/28/2000 006Manufacturing Change or Addition  
5/1/2000 005Manufacturing Change or Addition  
4/12/2000 004Manufacturing Change or Addition  
4/30/2003 002Labeling Revision Letter
Label 
2/7/1997 000Approval  
 
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