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FDA Drug Application 019842 by MCNEIL CONSUMER

Application Number019842
Application Type New Drug Application
Sponsor ApplicantMCNEIL CONSUMER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/19/1989N       
AP03/23/1993SLR       
AP03/24/1995SE1       
AP06/13/1994SCS       
AP06/23/1995SCS       
AP06/23/1995SCS       
AP06/23/1995SCS       
AP02/7/1996SCS       
AP02/22/1996SCS       
AP02/4/2002SLR14076013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20476s2_MotrinTOC.cfm 5/8/2006
AP07/18/2000SCS       
AP05/14/2001SCS       
AP01/24/2006SLR13490019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf 1/25/2006
AP01/24/2006SLR13536019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019842s019ltr.pdf 1/30/2006
AP09/10/2007SLR17838020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019842s020lbl.pdf 9/11/2007
AP09/10/2007SLR17853020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019842s020ltr.pdf 9/11/2007




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