Visitor Monitoring Drug History: DELSYM
 
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: DELSYM
FDA Application No: (NDA) 018658
Active Ingredient(s): DEXTROMETHORPHAN POLISTIREX
Company: ADAMS RESP THERAP
 
Label History
 
View the label approved on October 4, 2007 for DELSYM, (NDA) 018658


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
9/28/2007 022Formulation Revision Letter
Label 
3/8/2005 018Package Change Letter 
11/10/2004 017Formulation Revision Letter
Review 
7/10/2002 016Control Supplement  
1/24/2002 015Labeling Revision Letter 
2/15/2001 014Labeling Revision  
8/9/1999 013Control Supplement  
11/8/1999 012Manufacturing Change or Addition  
12/28/1992 011Control Supplement  
10/26/1993 010Labeling Revision  
10/26/1993 009Package Change  
8/10/1993 008Control Supplement  
10/9/1986 007Expiration Date Change  
6/12/1985 005Control Supplement  
6/11/1984 004Labeling Revision  
5/10/1985 002Control Supplement  
6/11/1984 001Labeling Revision  
10/8/1982 000Approval  
 
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