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FDA Drug Application 019012 by J AND J CONSUMER INC

Application Number019012
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 manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/18/1984N       
AP01/23/1986SCE       
AP012/16/1986SCM       
AP03/31/1997SLR       
AP07/29/1987SCM       
AP010/2/1990SCS       
AP07/25/1989SCM       
AP010/2/1990SCS       
AP012/17/1990SCP       
AP012/17/1990SCM       
AP03/25/1994SCP       
AP01/10/1995SCS       
AP011/20/1995SCS       
AP04/10/1996SCM       
AP02/25/2000SE11237016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19012S16LTR.PDF 2/25/2000
AP02/25/2000SE13642016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016_Ibuprofen_prntlbl.pdf 2/25/2000
AP02/25/2000SE13643016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016.cfm 5/14/2002
AP08/25/2000SLR       
AP012/6/1999SCP       
AP02/7/2000SCM       
AP011/21/1999SCM       
AP011/21/1999SCM       
AP03/22/2000SCP       
AP03/22/2000SCM       
AP010/2/2000SLR       
AP01/3/2001SCS       
AP03/5/2001SCM       
AP05/2/2001SCS       
AP09/7/2001SLR5317028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19012s28lbl.pdf 4/16/2003
AP03/27/2002SCM       
AP010/28/2003SLR6851034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr011ltr.pdf 10/31/2003
AP02/8/2006SLR13658037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019012s037ltr.pdf 2/22/2006
AP012/8/2006SCP15565038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019012s038ltr.pdf 12/28/2006
AP011/20/2007SLR18574040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019012s040_CKD.pdf 11/26/2007
AP04/24/2009SLR22382043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019012s043ltr.pdf 5/1/2009
AP010/21/2010SLR26775046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019012s046ltr.pdf 10/26/2010
AP010/21/2010SLR32238046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019012s046lbl.pdf 3/27/2012
AP012/4/2012SCM       
AP03/28/2013SCM       
AP03/11/2014SCM44389052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/019012Orig1s052.pdf 11/5/2015
AP07/31/2015SCM44390053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/019012Orig1s053.pdf 11/5/2015
AP05/6/2016SCM       
AP08/18/2016SLR46817055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019012Orig1s055ltr.pdf 8/19/2016
AP08/18/2016SLR46841055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019012Orig1s055lbl.pdf 8/22/2016




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