Visitor Monitoring Drug History: CYLERT
 
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: CYLERT
FDA Application No: (NDA) 016832
Active Ingredient(s): PEMOLINE
Company: ABBOTT
 
Label History
 
View the label approved on October 19, 2005 for CYLERT, (NDA) 016832


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
11/21/2003 022Labeling Revision Letter
Label 
1/6/2003 021Control Supplement  
9/12/2002 020Control Supplement  
9/4/2002 019Control Supplement  
5/28/1999 018Labeling Revision  
5/8/1998 016Package Change Review 
12/12/1997 015Labeling Revision Review 
9/9/1996 014Control Supplement Review 
4/11/1996 013Labeling Revision Review 
2/16/1990 012Manufacturing Change or Addition  
6/15/1987 011Labeling Revision  
9/6/1984 009Labeling Revision  
3/30/1979 006Labeling Revision  
6/6/1978 005Package Change  
10/12/1977 004Formulation Revision  
3/14/1979 003Labeling Revision  
3/25/1975 001Control Supplement  
1/27/1975 000Approval  
 
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