Visitor Monitoring Drug History: CHILDREN'S MOTRIN
 
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: CHILDREN'S MOTRIN
FDA Application No: (NDA) 020516
Active Ingredient(s): IBUPROFEN
Company: MCNEIL
 
Label History
 
View the label approved on September 13, 1999 for CHILDREN'S MOTRIN, (NDA) 020516


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
6/22/2006 020Control Supplement Letter 
12/7/2005 018Labeling Revision Letter 
2/7/2005 016Formulation Revision Letter 
12/19/2003 012Labeling Revision Letter 
10/28/2003 011Labeling Revision Letter 
5/2/2001 008Control Supplement  
7/18/2000 007Control Supplement  
10/2/2000 006Labeling Revision  
9/13/1999 004Labeling Revision Letter
Label
Review 
12/18/1998 003Formulation Revision  
6/4/1998 002Labeling Revision  
3/31/1997 001Labeling Revision  
6/16/1995 000Approval  
 
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