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FDA Drug Application 050718 by JANSSEN RES AND DEV

Application Number050718
Application Type New Drug Application
Sponsor ApplicantJANSSEN RES AND DEV
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/17/1995N       
AP03/8/1996SLR       
AP07/10/1996SCE       
AP07/31/1997SLR       
AP03/31/1998SCS       
AP06/28/1999SE11177006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50718s06ltr.pdf 6/28/1999
AP06/28/1999SE11178006   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50718s06lbl.pdf 6/28/1999
AP03/30/2000SCM       
AP06/13/2000SCP       
AP01/10/2002SLR8929010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50718s10ltr.pdf 6/2/2004
AP04/18/2002SCS       
AP08/9/2002SCP       
AP012/17/2002SCS       
AP010/27/2004SE810503019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50718s019ltr.pdf 10/29/2004
AP010/27/2004SE810525019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50718s019lbl.pdf 11/1/2004
AP010/27/2004SE830824019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050718Orig1s019.pdf 10/10/2011
AP01/28/2005SE711067020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50718s019,020ltr.pdf 2/3/2005
AP01/28/2005SE711068020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/50718s019,020lbl.pdf 2/3/2005
AP05/17/2007SLR16616028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050718s028,s029ltr.pdf 5/29/2007
AP05/17/2007SLR16631028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s028s029lbl.pdf 5/29/2007
AP05/17/2007SE116580029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050718s029lbl.pdf 5/18/2007
AP05/17/2007SE116617029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050718s028,s029ltr.pdf 5/29/2007
AP012/12/2013SCM       
AP06/10/2008SE720013033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050718s033ltr.pdf 6/13/2008
AP06/10/2008SE720036033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050718s033lbl.pdf 6/19/2008
AP06/10/2008SE720250033   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/050718se7-033_SUMR.pdf 7/17/2008
AP09/19/2012SLR33801043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050718s043lbl.pdf 9/20/2012
AP09/19/2012SLR33817043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050718Orig1s043ltr.pdf 9/24/2012
AP08/30/2013SLR36947045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050718Orig1s045ltr.pdf 9/4/2013
AP08/30/2013SLR37020045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050718s045lbl.pdf 9/9/2013
AP01/22/2015SCM41721046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050718s046lbl.pdf 1/29/2015
AP04/14/2014SCM       
AP04/16/2015SE842559048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050718Orig1s048ltr.pdf 4/17/2015
AP04/16/2015SE842566048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050718s048lbl.pdf 4/17/2015
AP010/9/2015SCM       
AP012/28/2015SCM44897050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050718Orig1s050ltr.pdf 12/29/2015
AP03/29/2016SCM       
AP04/25/2016SCM       




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