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FDA Drug Application 018701 by JANSSEN PHARMS

Application Number018701
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/14/1986N       
AP06/10/1986SCS       
AP02/24/1987SLR       
AP06/15/1987SCM       
AP06/15/1987SCM       
AP06/15/1987SLR       
AP010/28/1986SLR       
AP01/28/1987SCM       
AP01/28/1987SLR       
AP01/28/1987SCM       
AP01/28/1987SLR       
AP011/18/1986SLR       
AP08/24/1988SCM       
AP08/24/1988SCM       
AP09/28/1987SLR       
AP06/17/1988SCM       
AP01/18/1989SCS       
AP01/18/1989SCS       
AP010/20/1988SCM       
AP010/20/1988SLR       
AP01/19/1989SLR       
AP01/31/1997SCM       
AP01/31/1997SLR       
AP02/16/1989SCP       
AP05/10/1989SCM       
AP010/31/1989SLR       
AP012/21/1990SCM       
AP04/21/1993SLR       
AP06/29/1994SCS       
AP04/27/1993SLR       
AP05/22/1995SCM       
AP09/7/1994SCM       
AP05/10/1996SCM       
AP09/11/1997SCM       
AP06/23/1998SCP       
AP05/2/2000SLR       
AP04/13/2000SCM       
AP04/17/2002SLR17046046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018701_S046_HALDOL_TABLETS_AP.pdf 7/6/2007
AP05/4/2007SLR16438053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/015923s078,018701s053lbl.pdf 5/7/2007
AP05/4/2007SLR16483053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s078, 018701s053ltr.pdf 5/9/2007
AP08/12/2011SLR29783054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s079,018701s054ltr.pdf 8/15/2011
AP08/12/2011SLR29791054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018701s054lbl.pdf 8/16/2011
AP09/19/2007SLR17943055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/015923s080, 018701s055ltr.pdf 9/25/2007
AP05/13/2008SLR19826056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s081,018701s056ltr.pdf 5/14/2008
AP05/13/2008SLR19944056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s081,018701s056lbl.pdf 6/5/2008
AP08/14/2008SLR20620057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015923s082, 018701s057ltr.pdf 8/19/2008
AP08/14/2008SLR20708057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf 8/29/2008
AP07/19/2009SLR23024059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018701s059lbl.pdf 7/23/2009
AP07/19/2009SLR23114059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015923s084,018701s059ltr.pdf 8/4/2009
AP012/1/2010SLR27188062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018701s062lbl.pdf 12/4/2010
AP012/1/2010SLR27201062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/015923s085,018701s062ltr.pdf 12/6/2010
AP03/1/2011SLR28087063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/015923s086,018701s063lbl.pdf 3/4/2011
AP03/1/2011SLR28095063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/015923s086,018701s063ltr.pdf 3/7/2011
AP05/6/2013SLR35976065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/015923Orig1s089,018701Orig1s065ltr.pdf 5/7/2013
AP05/24/2013SCM       
AP06/5/2013SCM       
AP012/19/2013SCM       
AP05/18/2016SLR46072072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015923Orig1s094,018701Orig1s072ltr.pdf 5/20/2016
AP05/18/2016SLR46092072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015923s094,018701s072lbl.pdf 5/20/2016




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