Visitor Monitoring Drug History: SKELAXIN
 
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: SKELAXIN
FDA Application No: (NDA) 013217
Active Ingredient(s): METAXALONE
Company: KING PHARMS
 
Label History
 
View the label approved on December 4, 2006 for SKELAXIN, (NDA) 013217


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
11/24/2006 046Labeling Revision Letter
Label 
6/3/2002 045Control Supplement  
6/20/2002 044Labeling Revision Letter
Review 
4/16/2002 043Manufacturing Change or Addition  
9/26/2001 041Manufacturing Change or Addition  
1/31/2001 040Manufacturing Change or Addition  
5/4/2000 037Control Supplement  
8/30/2002 036Formulation Revision Letter
Label 
9/18/1998 035Manufacturing Change or Addition  
4/13/1999 034Control Supplement  
3/26/1998 033Manufacturing Change or Addition  
4/13/1999 032Control Supplement  
3/20/1997 031Manufacturing Change or Addition  
7/7/1997 030Control Supplement  
6/28/1995 029Control Supplement  
3/27/1995 028Package Change  
1/5/1995 027Manufacturing Change or Addition  
7/27/1992 025Package Change  
2/28/1989 024Control Supplement  
2/26/1987 020Manufacturing Change or Addition  
12/31/1985 019Control Supplement  
5/31/1985 018Control Supplement  
12/4/1985 017Labeling Revision  
3/27/1984 015Package Change  
3/27/1984 014Manufacturing Change or Addition  
1/16/1981 012Manufacturing Change or Addition  
1/16/1981 011Labeling Revision  
4/15/1980 010Manufacturing Change or Addition  
2/13/1980 009Labeling Revision  
2/26/1979 008Expiration Date Change  
4/4/1977 006Formulation Revision  
8/13/1962 000Approval  
 
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