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FDA Drug Application 020516 by J AND J CONSUMER INC

Application Number020516
Application Type New Drug Application
Sponsor ApplicantJ AND J CONSUMER INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/16/1995N       
AP03/31/1997SLR       
AP06/4/1998SLR       
AP012/18/1998SCF       
AP09/13/1999SLR2398004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf 9/13/1999
AP09/13/1999SLR2399004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf 9/13/1999
AP09/13/1999SLR2400004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm 9/13/1999
AP010/2/2000SLR       
AP07/18/2000SCS       
AP05/2/2001SCS       
AP010/28/2003SLR6852011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr011ltr.pdf 10/31/2003
AP012/19/2003SLR7349012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20516slr012,21128slr003ltr.pdf 12/23/2003
AP02/7/2005SCF11097016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20516s016ltr.pdf 2/9/2005
AP012/7/2005SLR13278018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020516s018ltr.pdf 12/15/2005
AP06/22/2006SCS14366020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020516s020LTR.pdf 6/28/2006
AP04/29/2009SLR22433021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020516s021ltr.pdf 5/6/2009
AP010/19/2010SLR26729022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020516s022ltr.pdf 10/22/2010
AP012/6/2011SLR30896024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020516s024ltr.pdf 12/8/2011
AP08/12/2012SCM       
AP011/19/2012SCM       
AP012/11/2014SLR41235029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020516Orig1s029ltr.pdf 12/12/2014
AP012/11/2014SLR41319029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020516Orig1s029lbl.pdf 12/19/2014
AP04/16/2015SLR42557030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020516Orig1s030ltr.pdf 4/17/2015
AP04/16/2015SLR42596030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf 4/21/2015
AP012/7/2015SCM       
AP06/17/2016SCM       
AP06/16/2016SLR46359033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020516Orig1s033ltr.pdf 6/21/2016
AP06/16/2016SLR46399033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020516Orig1s033lbl.pdf 6/22/2016




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