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FDA Drug Application 084349 by PARKE DAVIS

Application Number084349
Application Type Abbreviated New Drug Application
Sponsor ApplicantPARKE DAVIS
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
AP08/27/1976N       
AP05/27/1982SC       
AP06/2/1982SC       
AP06/2/1982SC       
AP05/18/1982SC       
AP04/9/1984SC       
AP04/9/1984SC       
AP04/9/1984SC       
AP06/14/1984SC       
AP010/15/1986SC       
AP02/11/1986SC       
AP08/25/1988SC       
AP08/25/1988SC       
AP03/22/1990SB       
AP011/15/1993SC       
AP02/12/1997SC       
AP02/11/1997SC       
AP04/3/1997SC       
AP09/19/1996SC       
AP03/25/1998SC       
AP03/25/1998SC       
AP08/8/2007SCM32247045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/084349Orig1s045BIOEQ_REV.pdf 3/28/2012
AP05/6/2009SLR23634060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf 10/19/2009
AP02/27/2014SLR38681062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf 3/6/2014
AP02/27/2014SLR38684062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072ltr.pdf 3/6/2014
AP04/8/2011SLR28718064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023MedG.pdf 5/5/2011
AP04/8/2011SLR28745064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf 5/6/2011
AP011/27/2012SLR34513067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084349s067lbl.pdf 11/30/2012
AP011/27/2012SLR34563067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/084349Orig1s067ltr.pdf 12/6/2012
AP08/6/2013SLR36725070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/084349Orig1s070ltr.pdf 8/8/2013
AP08/6/2013SLR37168070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084349Orig1s070lbl.pdf 9/19/2013
AP02/27/2014SLR38682072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf 3/6/2014
AP02/27/2014SLR38685072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/084349Orig1s062,s072ltr.pdf 3/6/2014
AP07/3/2014SLR40045073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s073lbl.pdf 7/29/2014
AP04/16/2015SLR42636074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084349Orig1s074lbl.pdf 4/23/2015
AP04/16/2015SLR42637074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/084349Orig1s074ltr.pdf 4/23/2015




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