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FDA Drug Application 021336 by SOMERSET

Application Number021336
Application Type New Drug Application
Sponsor ApplicantSOMERSET
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/27/2006N13711000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf 3/3/2006
AP02/27/2006N13717000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021708s000_021336s000ltr.pdf 3/3/2006
AP02/27/2006N15835000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088589.pdf 2/20/2007
AP02/27/2006N16499000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP02/27/2006N17812000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021336s000_021708s000TOC.cfm 9/10/2007
AP02/13/2008SLR19093001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021336s001ltr.pdf 2/14/2008
AP07/30/2007SLR17438002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021336s002lbl.pdf 7/31/2007
AP07/30/2007SLR17466002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021336s002ltr.pdf 8/2/2007
AP09/10/2014SLR40490005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf 9/16/2014
AP09/10/2014SLR40660005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf 9/30/2014
AP09/10/2014SE840491010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf 9/16/2014
AP03/27/2015SLR42339011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021336Orig1s011ltr.pdf 4/1/2015
AP03/27/2015SLR42367011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf 4/1/2015
AP010/16/2015SCM       




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