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FDA Drug Application 018817 by GD SEARLE LLC

Application Number018817
Application Type New Drug Application
Sponsor ApplicantGD SEARLE LLC
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
AP09/10/1984N       
AP06/4/1985SCF       
AP012/16/1986SE1       
AP010/20/1986SCS       
AP05/6/1986SCS       
AP06/27/1986SLR       
AP02/23/1988SE2       
AP04/29/1987SCS       
AP04/29/1987SLR       
AP04/29/1987SLR       
AP02/23/1988SLR       
AP04/13/1988SPF       
AP02/14/1990SLR       
AP08/12/1991SLR       
AP09/27/1991SLR       
AP011/4/1994SLR       
AP02/7/1996SCP       
AP05/14/1996SCM       
AP01/13/1998SLR       
AP07/9/2009SLR22980021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018817s021ltr.pdf 7/17/2009
AP07/9/2009SLR23037021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf 7/23/2009
AP04/13/2010SLR25274022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018817s022ltr.pdf 4/19/2010
AP04/13/2010SLR25299022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018817s022lbl.pdf 4/19/2010
AP06/29/2011SLR29370024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s024lbl.pdf 6/30/2011
AP06/29/2011SLR29397024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s024ltr.pdf 7/5/2011
AP011/2/2011SLR30490027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s027lbl.pdf 11/4/2011
AP011/2/2011SLR30522027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s027ltr.pdf 11/7/2011
AP02/13/2013SCM       
AP010/25/2013SLR37594031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018817Orig1s031ltr.pdf 10/28/2013
AP010/25/2013SLR37655031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018817s031lbl.pdf 10/31/2013
AP08/24/2016SLR46886032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018817Orig1s032ltr.pdf 8/25/2016
AP08/24/2016SLR46979032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018817s032lbl.pdf 9/6/2016




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