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FDA Drug Application 012616 by GD SEARLE LLC

Application Number012616
Application Type New Drug Application
Sponsor ApplicantGD SEARLE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/4/1978SOA       
AP01/23/1990SCM       
AP01/13/1999SLR       
AP04/21/1999SLR       
AP011/26/2002SCS       
AP05/19/2011SLR28893068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf 5/23/2011
AP05/19/2011SLR28922068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s068ltr.pdf 5/24/2011
AP09/22/2011SLR30080069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s069ltr.pdf 9/26/2011
AP06/14/2013SCM       
AP06/12/2013SLR36288073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012616Orig1s073ltr.pdf 6/13/2013
AP06/12/2013SLR36312073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf 6/18/2013
AP01/17/2014SLR38339074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s074ltr.pdf 1/21/2014
AP01/17/2014SLR38347074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s074lbl.pdf 1/22/2014
AP03/6/2014SLR38714075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s075ltr.pdf 3/7/2014
AP03/6/2014SLR38720075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s075lbl.pdf 3/7/2014
AP010/22/2014SLR40872076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf 10/24/2014




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