Visitor Monitoring Drug History: MOTRIN
 
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Label and Approval History

Drug Name: MOTRIN
FDA Application No: (NDA) 017463
Active Ingredient(s): IBUPROFEN
Company: MCNEIL PED
 
Label History
 
View the label approved on September 11, 2007 for MOTRIN, (NDA) 017463


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
9/10/2007 105Labeling Revision Letter
Label 
1/24/2006 104Labeling Revision Letter
Label 
5/14/2001 103Control Supplement  
6/20/2001 102Manufacturing Change or Addition  
11/29/1999 101Control Supplement  
7/20/1999 099Manufacturing Change or Addition  
11/20/1995 098Control Supplement  
11/15/1995 097Control Supplement  
3/23/1995 095Control Supplement  
10/19/1992 091Manufacturing Change or Addition  
12/26/1990 089Control Supplement  
7/25/1989 087Manufacturing Change or Addition  
6/22/1994 085Control Supplement  
10/2/1990 082Control Supplement  
2/16/1988 079Labeling Revision  
2/16/1988 078Labeling Revision  
2/16/1988 077Labeling Revision  
11/27/1987 075Labeling Revision  
12/16/1986 074Manufacturing Change or Addition  
10/10/1986 072Labeling Revision  
10/10/1986 071Labeling Revision  
10/10/1986 070Package Change  
11/6/1985 069Labeling Revision  
10/31/1990 068Formulation Revision  
12/22/1986 065Formulation Revision  
5/22/1985 063Labeling Revision  
5/29/1984 062Control Supplement  
4/9/1983 057Labeling Revision  
5/22/1985 053Labeling Revision  
3/1/1982 052Labeling Revision  
7/2/1981 051Expiration Date Change  
7/2/1981 050Expiration Date Change  
3/1/1982 049Labeling Revision  
3/31/1981 048Labeling Revision  
9/12/1980 047Expiration Date Change  
3/1/1982 046Labeling Revision  
12/21/1979 045Control Supplement  
1/31/1980 044Control Supplement  
6/20/1979 042Manufacturing Change or Addition  
4/16/1979 041Manufacturing Change or Addition  
8/21/1979 040General Efficacy (MarkIV)  
3/22/1979 039Package Change  
2/27/1979 038Expiration Date Change  
9/12/1978 035Package Change  
2/9/1979 034Control Supplement  
8/8/1978 032Manufacturing Change or Addition  
2/23/1978 031Control Supplement  
4/21/1978 030Manufacturing Change or Addition  
2/3/1978 029Expiration Date Change  
4/7/1977 028Supplement  
8/21/1979 024Labeling Revision  
12/14/1976 022Distributor  
9/8/1976 019Manufacturing Change or Addition  
8/27/1976 018Labeling Revision  
5/3/1976 017   
3/1/1976 016Labeling Revision  
11/12/1975 013Labeling Revision  
11/12/1975 012Control Supplement  
11/12/1975 011Labeling Revision  
5/3/1976 010Control Supplement  
11/11/1975 008Control Supplement  
9/19/1974 000Approval  
 
Therapeutic Equivalents
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