Visitor Monitoring Drug History: CARNITOR
 
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Label and Approval History

Drug Name: CARNITOR
FDA Application No: (NDA) 018948
Active Ingredient(s): LEVOCARNITINE
Company: SIGMA TAU
 
Label History
 
View the label approved on March 31, 2007 for CARNITOR, (NDA) 018948


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
3/28/2007 024Labeling Revision Letter
Label 
4/15/2002 022Labeling Revision Letter
Label 
12/15/1998 021Labeling Revision  
10/21/1997 020Manufacturing Change or Addition  
1/27/1997 019Control Supplement  
4/16/1996 018Control Supplement  
12/20/1995 017Package Change  
7/14/1992 016Labeling Revision Review 
7/22/1992 015Labeling Revision  
4/14/1992 013Control Supplement  
4/13/1994 012Control Supplement  
5/11/1993 011Manufacturing Change or Addition  
2/21/1992 010Labeling Revision  
12/16/1992 009New or Modified Indication  
12/7/1989 008Package Change  
12/7/1989 007Formulation Revision  
3/22/1989 006Formulation Revision  
9/16/1988 005Labeling Revision  
4/27/1988 004Formulation Revision  
12/27/1985 000Approval  
 
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