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FDA Drug Application 012151 by GD SEARLE LLC

Application Number012151
Application Type New Drug Application
Sponsor ApplicantGD SEARLE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/21/1960N       
AP011/10/1976SLR       
AP06/30/1981SES       
AP03/4/1981SCP       
AP011/29/1983SCF       
AP06/22/1981SCM       
AP07/30/1997SPD       
AP011/29/1983SCF       
AP05/3/1982SLR       
AP012/30/1982SCF       
AP04/7/1983SCF       
AP07/29/1983SLR       
AP012/20/1983SLR       
AP03/22/1984SLR       
AP011/5/1984SLR       
AP08/15/1985SCM       
AP09/26/1985SLR       
AP01/13/1986SLR       
AP011/23/1987SCE       
AP06/15/1987SCS       
AP011/9/1988SLR       
AP010/30/1989SLR       
AP03/15/1990SLR       
AP01/23/1990SCM       
AP05/7/1992SLR       
AP07/30/1997SLR       
AP05/31/1995SCP       
AP05/14/1996SCM       
AP01/13/1999SLR       
AP03/26/1999SLR       
AP011/26/2002SCS       
AP011/25/2008SLR21282062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/012151s062ltr.pdf 11/26/2008
AP011/25/2008SLR21496062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf 1/2/2009
AP09/22/2011SLR30081067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012151s067ltr.pdf 9/26/2011
AP09/17/2012N33791068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012151s068lbl.pdf 9/17/2012
AP09/17/2012N33799068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012151Orig1s068ltr.pdf 9/20/2012
AP06/12/2013SLR36289071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012151Orig1s071ltr.pdf 6/13/2013
AP06/12/2013SLR36311071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012151s071lbl.pdf 6/18/2013
AP010/22/2014SLR40873072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012151s072lbl.pdf 10/24/2014
AP05/1/2015SCM       
AP04/11/2016SCM       




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