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FDA Drug Application 020603 by J AND J CONSUMER INC

Application Number020603
Application Type New Drug Application
Sponsor ApplicantJ AND J CONSUMER INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/10/1996N       
AP06/12/1998SLR2395001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_Approv.pdf 6/12/1998
AP06/12/1998SLR2396001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_prntlbl.pdf 6/12/1998
AP06/12/1998SLR2397001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603s001_Ibuprofen.cfm 6/12/1998
AP09/13/1999SLR2407002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf 9/13/1999
AP09/13/1999SLR2408002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf 9/13/1999
AP09/13/1999SLR2409002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm 9/13/1999
AP04/15/1999SE51890003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S3_InfantsMotrin.pdf 4/15/1999
AP05/3/2001SCS       
AP01/16/2002SCP1891005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20603s5ltr.pdf 1/16/2002
AP01/16/2002SCP1892005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20603s5lbl.pdf 1/16/2002
AP02/27/2006SLR13674011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020603s011ltr.pdf 3/1/2006
AP04/29/2009SLR22434013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020603s013ltr.pdf 5/6/2009
AP07/15/2010SLR25974014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020603s014ltr.pdf 7/19/2010
AP012/4/2015SCM       
AP08/29/2016SLR46921021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020603Orig1s021lbl.pdf 8/30/2016
AP08/29/2016SLR46931021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020603Orig1s021ltr.pdf 9/1/2016




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