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FDA Drug Application 022363 by KOWA CO

Application Number022363
Application Type New Drug Application
Sponsor ApplicantKOWA CO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/3/2009N23227000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022363s000lbl.pdf 8/26/2009
AP08/3/2009N23234000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022363s000ltr.pdf 8/26/2009
AP08/3/2009N24109000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022363s000TOC.cfm 11/23/2009
AP06/1/2010SLR25713002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022363s002ltr.pdf 6/8/2010
AP06/16/2011SLR29190005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s005lbl.pdf 6/16/2011
AP06/16/2011SLR29264005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022363s005ltr.pdf 6/27/2011
AP08/3/2011SLR29682006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022363s006ltr.pdf 8/5/2011
AP08/3/2011SLR29708006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s006lbl.pdf 8/5/2011
AP02/28/2012SLR31942008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363s008,s009ltr.pdf 2/28/2012
AP02/28/2012SLR31953008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009lbl.pdf 2/28/2012
AP02/28/2012SLR31955008Tracked Changes Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009-trackedchangeslbl.pdf 2/28/2012
AP02/28/2012SLR32298008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022363s008s009.pdf 3/30/2012
AP02/28/2012SLR32523009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022363s008s009.pdf 4/24/2012
AP02/28/2012SLR31956009Tracked Changes Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009-trackedchangeslbl.pdf 2/28/2012
AP02/28/2012SLR31954009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009lbl.pdf 2/28/2012
AP02/28/2012SLR31943009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363s008,s009ltr.pdf 2/28/2012
AP010/31/2012SLR34276010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363Orig1s010ltr.pdf 11/6/2012
AP010/31/2012SLR34316010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s010lbl.pdf 11/6/2012
AP010/16/2013SLR37451012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022363Orig1s012ltr.pdf 10/18/2013
AP010/16/2013SLR37463012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022363s012lbl.pdf 10/18/2013
AP04/21/2015SCM       




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