Visitor Monitoring Drug History: MONOKET
 
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: MONOKET
FDA Application No: (NDA) 020215
Active Ingredient(s): ISOSORBIDE MONONITRATE
Company: SCHWARZ
 
Label History
 
Labels are not available on this site for MONOKET, (NDA) 020215
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/15/2002 013Control Supplement  
2/22/2000 012Manufacturing Change or Addition  
1/19/2000 011Labeling Revision  
10/26/1999 010Manufacturing Change or Addition  
10/29/1999 009Manufacturing Change or Addition  
1/13/1999 008Labeling Revision  
8/7/1997 006Manufacturing Change or Addition  
8/25/1997 005Manufacturing Change or Addition  
11/20/1995 004Manufacturing Change or Addition  
3/12/1996 003Manufacturing Change or Addition  
9/2/1994 002Labeling Revision  
12/15/1993 001Control Supplement  
6/30/1993 000Approval  
 
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