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FDA Drug Application 201277 by BAYER HLTHCARE

Application Number201277
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
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
AP03/14/2011N28249000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201277s000lbl.pdf 3/15/2011
AP03/14/2011N28264000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201277s000ltr.pdf 3/16/2011
AP03/14/2011N28496000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201277Orig1s000TOC.cfm 4/11/2011
AP03/14/2011N28497000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201277Orig1s000SumR.pdf 4/11/2011
AP03/22/2012SLR32186001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201277s001ltr.pdf 3/26/2012
AP07/31/2013SCM       
AP010/17/2013SLR37458003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201277Orig1s003ltr_replace.pdf 10/18/2013
AP010/17/2013SLR37502003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201277s003lbl.pdf 10/21/2013
AP012/18/2013SCM       
AP06/11/2014SE839531007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201277Orig1s007ltr.pdf 6/12/2014
AP012/29/2014SE841460008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201277Orig1s008ltr.pdf 12/31/2014
AP012/29/2014SE841489008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201277s008lbl.pdf 1/5/2015
AP06/1/2015SCM       
AP07/31/2015SLR43558010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201277Orig1s010ltr.pdf 8/3/2015
AP07/31/2015SLR43930010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201277s010lbl.pdf 9/21/2015
AP04/27/2016SE845793011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201277Orig1s011ltr.pdf 4/28/2016
AP04/27/2016SE845873011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201277s011lbl.pdf 5/5/2016
AP011/25/2015SCM       




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